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A family of stool tests for hidden blood and the laboratory machines that read them, cleared by the FDA from 2010 onwards.
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".
An immunochemical test detects hidden blood (haemoglobin) in a small stool sample; the analyser reads the result in the laboratory.
| Region | Year | Indication |
|---|---|---|
| US | 2010 | Faecal occult blood (immunochemical) test, 510(k) K092330; later clearances K143325 (2015) and K191147 (2020) |
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Query for this drug: (TITLE:"OC-Sensor faecal immunochemical tests" OR ABSTRACT:"OC-Sensor faecal immunochemical tests" OR TITLE:"Eiken, Polymedco" OR ABSTRACT:"Eiken, Polymedco" OR TITLE:"OC-Sensor" OR ABSTRACT:"OC-Sensor" OR TITLE:"OC-Auto SENSOR io" OR ABSTRACT:"OC-Auto SENSOR io" OR TITLE:"OC-SENSOR DIANA" OR ABSTRACT:"OC-SENSOR DIANA" OR TITLE:"OC-Light S FIT" OR ABSTRACT:"OC-Light S FIT") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about OC-Sensor faecal immunochemical tests (Eiken, Polymedco), not a curated reading list.
Shares Cologuard, FDA medical device databases (PMA, 510(k), De Novo), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
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