{"id":"AIBD-0905","title":"FDA found that white cell differentials from Medica's EasyCell, preclassified by a neural network, correlated 0.93 to 0.99 with manual microscopy","summary":"In FDA's review, EasyCell's technologist-reviewed white cell differentials on 304 specimens correlated with manual microscopy at 0.93 to 0.99, including 0.99 for neutrophils.","date_observed":"2010-05-12","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Medica Corporation makes the EasyCell Cell Locator. It scans stained blood smears, captures images of the cells and preclassifies white cells with a neural-network classifier. A trained technologist accepts or changes each suggested class. In a method comparison study, 304 specimens were collected and analyzed at three sites. Of these, 155 came from healthy people and 149 from people with specific diseases. Two technologists at each site read blinded slides with EasyCell and by manual microscopy. FDA reviewers report correlation coefficients of 0.99 for neutrophils, 0.98 for lymphocytes, 0.97 for eosinophils and 0.93 for monocytes. In flagging abnormal slides, EasyCell agreed with the manual reading on 84% of slides, with 91% sensitivity and 72% specificity. FDA cleared the device as substantially equivalent on 12 May 2010. The results include the technologists' review, so the classifier's accuracy alone is not reported.","category":"aggregate result","unexpected":false,"purpose":"Medica built the EasyCell Cell Locator to locate and display images of blood cells on stained smears and to suggest a class for each white cell, which a technologist confirms.","system":"EasyCell Cell Locator (EasyCell)","model_version":null,"developer":"Medica Corporation","deployer":"Medica Corporation (method comparison study at three sites)","location":"Three study sites (not named in the decision summary)","domain":"Healthcare (laboratory hematology)","segment":null,"benefit_type":"Repetitive Task Automation","work_activities":["4.A.1.b.1","4.A.2.a.2"],"taxonomy_note":null,"registry_ids":{},"ratings":[{"group":"organizational","depth":null,"reason":"The study measured agreement with manual microscopy, and no gain in time or accuracy at any laboratory is reported."}],"ai_role":{"status":"unassessed","statement":"FDA's reviewers write that a neural-network classifier preclassifies the white cells. The study compared technologist-reviewed results with manual microscopy and did not report the classifier's suggestions alone or compare work with and without the device."},"evidence":[{"kind":"regulatory document","citation":"U.S. Food and Drug Administration, Center for Devices and Radiological Health. 510(k) substantial equivalence determination decision summary, k092116: EasyCell Cell Locator (Medica Corporation). Decision date 12 May 2010.","title":"510(k) Substantial Equivalence Determination Decision Summary, k092116: EasyCell Cell Locator","url":"https://www.accessdata.fda.gov/cdrh_docs/reviews/K092116.pdf","date":"2010-05-12","written_by":"independent","quote":"A total of 304 specimens, including 155 specimens from normal (healthy) subjects and 149 from subjects with specific disease conditions, were collected and analyzed at three sites."},{"kind":"regulatory document","citation":"U.S. Food and Drug Administration, Center for Devices and Radiological Health. 510(k) substantial equivalence determination decision summary, k092116: EasyCell Cell Locator (Medica Corporation). Principles of operation.","title":"510(k) Substantial Equivalence Determination Decision Summary, k092116: EasyCell Cell Locator","url":"https://www.accessdata.fda.gov/cdrh_docs/reviews/K092116.pdf","date":"2010-05-12","written_by":"independent","quote":"Preclassification is accomplished using a neural-network classifier."}],"replication":{"produced_by":["Two microscopes with CCD cameras captured images of cells on oiled smears.","A neural-network classifier sorted the white cells into eight categories.","Technologists reviewed each suggested classification."],"must_hold":["Skilled operators trained on the device and in identifying blood cells use it.","Daily quality control on one normal and one abnormal slide passes before samples are run."],"echoes":[]},"paired_incident":null,"headline":"*EasyCell* white cell counts track manual microscopy in FDA's review","metric":"correlation coefficients of 0.99 for neutrophils","comparator":{"against":"Manual WBC differential by microscopy on the same specimens","before":"Manual 200-cell differential (reference)","after":"Correlation coefficient 0.99 for neutrophils, 0.98 for lymphocytes, 0.97 for eosinophils and 0.93 for monocytes","basis":"measured","quote":"Results from Deming regression analyses on readings with EasyCell and manual WBC differential are as follows","url":"https://www.accessdata.fda.gov/cdrh_docs/reviews/K092116.pdf"},"later":null,"value":null,"developer_country":"United States","deployer_country":"United States","unrated_because":"The study measured agreement with manual microscopy, so no realized outcome is reported for any group.","brief_notes":null,"brief":null,"revisions":[{"date":"2026-10-31","change":"Added the record from the finding of the U.S. Food and Drug Administration.","source":"https://www.accessdata.fda.gov/cdrh_docs/reviews/K092116.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. The cited evidence includes no independent study or report.","case_jurisdictions":[],"profile":{"case_id":"AIBD-0905","catalog_version":"1.0.0","source_fingerprint":"79d1a4911b8c07bd44d83d7c8adadd68403e8b367ba8209635ff24213cdfc892","collection_refs":[{"collection_id":"aibd","version":"2026-10-31"},{"collection_id":"querist","version":"2026-10-25"}],"source_ids":["AIBD-0905-source-0001","AIBD-0905-source-0002"],"families":{"strategic assessments":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"Editorial assignment.","review_state":"not_assessed","coverage":"partial","record_ids":[]},"evaluations":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"Editorial assignment.","review_state":"not_assessed","coverage":"partial","record_ids":[]},"monetary observations":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"Editorial assignment.","review_state":"not_assessed","coverage":"partial","record_ids":[]},"institutional decisions":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"Editorial assignment.","review_state":"not_assessed","coverage":"partial","record_ids":[]}},"fields":{"actors[]":{"state":"value_present","value":{"kind":"record_fields","fields":{"developer":"Medica Corporation","deployer":"Medica Corporation (method comparison study at three sites)"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["developer","deployer"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"actors[].ownership_control":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"ai_contribution":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"ai_relationship":{"state":"value_present","value":{"kind":"record_fields","fields":{"category":"aggregate result","ai_role":{"status":"unassessed","statement":"FDA's reviewers write that a neural-network classifier preclassifies the white cells. The study compared technologist-reviewed results with manual microscopy and did not report the classifier's suggestions alone or compare work with and without the device."}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ai_role","category"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"assessments[].alternatives":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"assessments[].assessor_date":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"assessments[].depth":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"assessments[].display_confidence":{"state":"value_present","value":{"kind":"structured","data":{"confidence":"high","evidence_word":"found","claim_status":"Found by a regulator","basis":"Sources: one independent regulatory document. The cited evidence includes no independent study or report.","interpretation":"Existing display rule preserved; the richer outcome-specific confidence question still needs review."}},"provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"assessments[].rationale":{"state":"value_present","value":{"kind":"record_fields","fields":{"ratings":[{"group":"organizational","reason":"The study measured agreement with manual microscopy, and no gain in time or accuracy at any laboratory is reported."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ratings"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"assessments[].rubric_version":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"assessments[].status_basis":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"assessments[].target":{"state":"value_present","value":{"kind":"record_fields","fields":{"ratings":[{"group":"organizational","reason":"The study measured agreement with manual microscopy, and no gain in time or accuracy at any laboratory is reported."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ratings"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"availability":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"brief":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"case_kind":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"case_links[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"claims[].evidence_links":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"claims[].evidence_strength":{"state":"value_present","value":{"kind":"structured","data":{"answer":"Found by a regulator. Sources: one independent regulatory document. The cited evidence includes no independent study or report.","evidence_word":"found","claim_status":"Found by a regulator"}},"provenance":{"kind":"source_review","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":["AIBD-0905-source-0001","AIBD-0905-source-0002"],"reviewed_on":"2026-10-29"},"review_state":"reviewed","coverage":"complete","display":{"answer":"Found by a regulator. Sources: one independent regulatory document. The cited evidence includes no independent study or report.","inferred":false}},"claims[].missingness":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"claims[].proposition":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"cross_border_flows[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"decisions[].action_outcome":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"institutional decisions"},"decisions[].grounds":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"institutional decisions"},"decisions[].institution_task":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"institutional decisions"},"decisions[].success_criterion":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"institutional decisions"},"deployment_stage":{"state":"value_present","value":{"kind":"structured","data":{"classification":"laboratory test","answer":"The system was tested in a laboratory. A method comparison on 304 specimens at three sites before clearance.","scope":"The period and activity described in the case."}},"provenance":{"kind":"source_review","basis":"Editorial assignment.","record_fields":["account","evidence"],"source_refs":["AIBD-0905-source-0001"],"reviewed_on":"2026-10-29"},"review_state":"reviewed","coverage":"complete","display":{"answer":"The system was tested in a laboratory. A method comparison on 304 specimens at three sites before clearance.","inferred":false}},"economics[].amount":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].costs[]":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].counterfactual":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].currency_price_basis":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].gross_net":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].measure_type":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].period_unit":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].realization":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].recipient_payer":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].return_payback":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].valuation_method":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"evaluations[].ai_uplift":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].comparator":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].design":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].effect":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].exposure":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].id":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].measurement_method":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].metric":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].reproduction_materials":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].setting_sample":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].uncertainty_limitations":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"external_references[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"follow_up[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"human_oversight":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"id":{"state":"value_present","value":{"kind":"record_fields","fields":{"id":"AIBD-0905"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["id"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"infrastructure_dependencies[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].beneficiaries":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].beneficiary_count":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].benefit_type":{"state":"value_present","value":{"kind":"record_fields","fields":{"benefit_type":"Repetitive Task Automation"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["benefit_type"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].claim":{"state":"value_present","value":{"kind":"record_fields","fields":{"account":"Medica Corporation makes the EasyCell Cell Locator. It scans stained blood smears, captures images of the cells and preclassifies white cells with a neural-network classifier. A trained technologist accepts or changes each suggested class. In a method comparison study, 304 specimens were collected and analyzed at three sites. Of these, 155 came from healthy people and 149 from people with specific diseases. Two technologists at each site read blinded slides with EasyCell and by manual microscopy. FDA reviewers report correlation coefficients of 0.99 for neutrophils, 0.98 for lymphocytes, 0.97 for eosinophils and 0.93 for monocytes. In flagging abnormal slides, EasyCell agreed with the manual reading on 84% of slides, with 91% sensitivity and 72% specificity. FDA cleared the device as substantially equivalent on 12 May 2010. The results include the technologists' review, so the classifier's accuracy alone is not reported.","benefit_type":"Repetitive Task Automation"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","benefit_type"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].distribution":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].duration":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].id":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].stakeholder_group":{"state":"value_present","value":{"kind":"record_fields","fields":{"ratings":[{"group":"organizational","reason":"The study measured agreement with manual microscopy, and no gain in time or accuracy at any laboratory is reported."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ratings"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].status":{"state":"value_present","value":{"kind":"record_fields","fields":{"benefit_status":"intended"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["benefit_status"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].tradeoffs":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].unexpected":{"state":"value_present","value":{"kind":"record_fields","fields":{"unexpected":false,"purpose":"Medica built the EasyCell Cell Locator to locate and display images of blood cells on stained smears and to suggest a class for each white cell, which a technologist confirms."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["unexpected","purpose"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"places[]":{"state":"value_present","value":{"kind":"record_fields","fields":{"location":"Three study sites (not named in the decision summary)","developer_country":"United States","deployer_country":"United States"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["location","developer_country","deployer_country"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"purpose":{"state":"value_present","value":{"kind":"record_fields","fields":{"purpose":"Medica built the EasyCell Cell Locator to locate and display images of blood cells on stained smears and to suggest a class for each white cell, which a technologist confirms."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["purpose"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"record_dates":{"state":"value_present","value":{"kind":"record_fields","fields":{"date_observed":"2010-05-12","date_basis":"source publication","date_precision":"day","revisions":[{"date":"2026-10-31","change":"Added the record from the finding of the U.S. Food and Drug Administration.","source":"https://www.accessdata.fda.gov/cdrh_docs/reviews/K092116.pdf","editor":"AIBD"}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["date_observed","date_basis","date_precision","revisions"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"replication.attempts[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"replication.conditions":{"state":"value_present","value":{"kind":"record_fields","fields":{"replication":{"produced_by":["Two microscopes with CCD cameras captured images of cells on oiled smears.","A neural-network classifier sorted the white cells into eight categories.","Technologists reviewed each suggested classification."],"must_hold":["Skilled operators trained on the device and in identifying blood cells use it.","Daily quality control on one normal and one abnormal slide passes before samples are run."],"echoes":[]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"revision_history[]":{"state":"value_present","value":{"kind":"record_fields","fields":{"revisions":[{"date":"2026-10-31","change":"Added the record from the finding of the U.S. Food and Drug Administration.","source":"https://www.accessdata.fda.gov/cdrh_docs/reviews/K092116.pdf","editor":"AIBD"}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["revisions"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sector":{"state":"value_present","value":{"kind":"record_fields","fields":{"domain":"Healthcare (laboratory hematology)"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["domain"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].access_version":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"sources[].citation_locator":{"state":"value_present","value":{"kind":"record_fields","fields":{"evidence":[{"kind":"regulatory document","citation":"U.S. Food and Drug Administration, Center for Devices and Radiological Health. 510(k) substantial equivalence determination decision summary, k092116: EasyCell Cell Locator (Medica Corporation). Decision date 12 May 2010.","title":"510(k) Substantial Equivalence Determination Decision Summary, k092116: EasyCell Cell Locator","url":"https://www.accessdata.fda.gov/cdrh_docs/reviews/K092116.pdf","date":"2010-05-12","written_by":"independent","quote":"A total of 304 specimens, including 155 specimens from normal (healthy) subjects and 149 from subjects with specific disease conditions, were collected and analyzed at three sites."},{"kind":"regulatory document","citation":"U.S. Food and Drug Administration, Center for Devices and Radiological Health. 510(k) substantial equivalence determination decision summary, k092116: EasyCell Cell Locator (Medica Corporation). Principles of operation.","title":"510(k) Substantial Equivalence Determination Decision Summary, k092116: EasyCell Cell Locator","url":"https://www.accessdata.fda.gov/cdrh_docs/reviews/K092116.pdf","date":"2010-05-12","written_by":"independent","quote":"Preclassification is accomplished using a neural-network classifier."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].id":{"state":"value_present","value":{"kind":"identifiers","identifiers":["AIBD-0905-source-0001","AIBD-0905-source-0002"],"role":"Existing evidence items, in their original order"},"provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"complete"},"sources[].language":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"sources[].relationship":{"state":"value_present","value":{"kind":"record_fields","fields":{"evidence":[{"kind":"regulatory document","citation":"U.S. Food and Drug Administration, Center for Devices and Radiological Health. 510(k) substantial equivalence determination decision summary, k092116: EasyCell Cell Locator (Medica Corporation). Decision date 12 May 2010.","title":"510(k) Substantial Equivalence Determination Decision Summary, k092116: EasyCell Cell Locator","url":"https://www.accessdata.fda.gov/cdrh_docs/reviews/K092116.pdf","date":"2010-05-12","written_by":"independent","quote":"A total of 304 specimens, including 155 specimens from normal (healthy) subjects and 149 from subjects with specific disease conditions, were collected and analyzed at three sites."},{"kind":"regulatory document","citation":"U.S. Food and Drug Administration, Center for Devices and Radiological Health. 510(k) substantial equivalence determination decision summary, k092116: EasyCell Cell Locator (Medica Corporation). Principles of operation.","title":"510(k) Substantial Equivalence Determination Decision Summary, k092116: EasyCell Cell Locator","url":"https://www.accessdata.fda.gov/cdrh_docs/reviews/K092116.pdf","date":"2010-05-12","written_by":"independent","quote":"Preclassification is accomplished using a neural-network classifier."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].upstream_sources":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"strategic_assessments[]":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"strategic assessments"},"summary":{"state":"value_present","value":{"kind":"record_fields","fields":{"summary":"In FDA's review, EasyCell's technologist-reviewed white cell differentials on 304 specimens correlated with manual microscopy at 0.93 to 0.99, including 0.99 for neutrophils.","account":"Medica Corporation makes the EasyCell Cell Locator. It scans stained blood smears, captures images of the cells and preclassifies white cells with a neural-network classifier. A trained technologist accepts or changes each suggested class. In a method comparison study, 304 specimens were collected and analyzed at three sites. Of these, 155 came from healthy people and 149 from people with specific diseases. Two technologists at each site read blinded slides with EasyCell and by manual microscopy. FDA reviewers report correlation coefficients of 0.99 for neutrophils, 0.98 for lymphocytes, 0.97 for eosinophils and 0.93 for monocytes. In flagging abnormal slides, EasyCell agreed with the manual reading on 84% of slides, with 91% sensitivity and 72% specificity. FDA cleared the device as substantially equivalent on 12 May 2010. The results include the technologists' review, so the classifier's accuracy alone is not reported."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["summary","account"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].autonomy_permissions":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].component_role":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].deployment_configuration":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].inputs_outputs":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_name":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_version":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].product_name":{"state":"value_present","value":{"kind":"record_fields","fields":{"system":"EasyCell Cell Locator (EasyCell)"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["system"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].provider":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"taxonomy_crosswalks[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"title":{"state":"value_present","value":{"kind":"record_fields","fields":{"title":"FDA found that white cell differentials from Medica's EasyCell, preclassified by a neural network, correlated 0.93 to 0.99 with manual microscopy","headline":"*EasyCell* white cell counts track manual microscopy in FDA's review"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["title","headline"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"version":{"state":"value_present","value":{"kind":"identifiers","identifiers":["ae75857054d72099d091d5f107ace746f2a5c8c357d343733a1524ebdf88a74b"],"role":"SHA-256 of the complete public record and its assessments"},"provenance":{"kind":"curatorial","basis":"SHA-256 of the public record, its assessments, and its displayed answers and notes, excluding its own identifier and the derived coverage summary.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"complete"},"workflow":{"state":"value_present","value":{"kind":"record_fields","fields":{"account":"Medica Corporation makes the EasyCell Cell Locator. It scans stained blood smears, captures images of the cells and preclassifies white cells with a neural-network classifier. A trained technologist accepts or changes each suggested class. In a method comparison study, 304 specimens were collected and analyzed at three sites. Of these, 155 came from healthy people and 149 from people with specific diseases. Two technologists at each site read blinded slides with EasyCell and by manual microscopy. FDA reviewers report correlation coefficients of 0.99 for neutrophils, 0.98 for lymphocytes, 0.97 for eosinophils and 0.93 for monocytes. In flagging abnormal slides, EasyCell agreed with the manual reading on 84% of slides, with 91% sensitivity and 72% specificity. FDA cleared the device as substantially equivalent on 12 May 2010. The results include the technologists' review, so the classifier's accuracy alone is not reported.","replication":{"produced_by":["Two microscopes with CCD cameras captured images of cells on oiled smears.","A neural-network classifier sorted the white cells into eight categories.","Technologists reviewed each suggested classification."],"must_hold":["Skilled operators trained on the device and in identifying blood cells use it.","Daily quality control on one normal and one abnormal slide passes before samples are run."],"echoes":[]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"}},"summary":{"total":91,"addressed":91,"known":27,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":25,"review_not_assessed":64,"not_assessed":0,"complete":false,"by_state":{"value_present":27,"not_reported":0,"unresolved":64,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"787799f29d4953fb025a23100bc5f5a4c451a4508b2027ce7a1161dbc2e47798"}