{"entity":{"id":"oc-sensor-fit","kind":"drug","name":"OC-Sensor faecal immunochemical tests (Eiken, Polymedco)","aka":["OC-Auto SENSOR io","OC-SENSOR DIANA","OC-Light S FIT","OC Sensor FIT"],"tldr":"A family of stool tests for hidden blood and the laboratory machines that read them, cleared by the FDA from 2010 onwards.","summary":"The FDA cleared the OC-SENSOR DIANA iFOB Test (Polymedco Cancer Diagnostics, 510(k) K092330) on 8 January 2010, the OC-Light S FIT (Eiken Chemical, K143325) on 20 August 2015 and the OC-Auto SENSOR io iFOB Test (Eiken Chemical, K191147) on 2 January 2020, under 21 CFR 864.6550 (occult blood tests, class II). The analyser product code is defined by the FDA as \"intended for the qualitative detection of fecal occult blood in feces by professional laboratories\".","status":"approved","asOf":"2026-11-04","links":[{"label":"FDA 510(k) K092330","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K092330"},{"label":"FDA 510(k) K143325","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K143325"},{"label":"FDA 510(k) K191147","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191147"}],"tags":["test","screening-test"],"related":["cologuard","faecal-occult-blood-test","fda-device-databases"],"cancers":[],"sections":["early-detection","diagnostics"],"technologies":["colorectal-screening"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["fit-test","screening"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"OC-Sensor","modality":"Faecal immunochemical test (FIT) for hidden blood, with laboratory analysers","mechanism":"An immunochemical test detects hidden blood (haemoglobin) in a small stool sample; the analyser reads the result in the laboratory.","approvals":[{"region":"US","year":2010,"indication":"Faecal occult blood (immunochemical) test, 510(k) K092330; later clearances K143325 (2015) and K191147 (2020)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/oc-sensor-fit/","neighbours":{"drug":[{"id":"cologuard","kind":"drug","name":"Cologuard","route":"/drugs/cologuard/"}],"term":[{"id":"fit-test","kind":"term","name":"Faecal immunochemical test (FIT)","route":"/terms/fit-test/"},{"id":"faecal-occult-blood-test","kind":"term","name":"Faecal occult blood test (guaiac)","route":"/terms/faecal-occult-blood-test/"},{"id":"screening","kind":"term","name":"Screening","route":"/terms/screening/"}],"collection":[{"id":"fda-device-databases","kind":"collection","name":"FDA medical device databases (PMA, 510(k), De Novo)","route":"/collections/fda-device-databases/"}],"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"},{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"colorectal-screening","kind":"technology","name":"Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood)","route":"/technologies/colorectal-screening/"}]}}