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510(k)

The system, which automates the process of performing blood cell differentials, was cleared by the US Food and Drug Administration last month.

The FDA cleared a CellaVision test that provides differential counts of white blood cells, characterization of red blood cell morphology, and platelet estimations.

The product, which received the CE mark earlier this year, uses digital imaging and AI to automate peripheral blood smear analysis.

The company first submitted for 510(k) clearance last year and has received two additional information requests from the agency.

Fujirebio Diagnostics got the nod for a chemiluminescent enzyme immunoassay to measure levels of CA 15-3 and manage patients diagnosed with breast cancer.

The proposed order is intended to give patients more timely access to the tests by moving them from Class III to Class II and providing special controls.

The FDA granted clearance to consumer genetic testing company Ancestry.com for the over-the-counter use of a health risk test for hereditary thrombophilia.

The test is for use with the company's Liaison MDx instrument and can be used alone or with the Simplexa COVID-19 Direct kit.

The RT-PCR test runs on the Cobas 6800/8800 Systems and had previously received breakthrough device designation from the FDA.

The companies are positioning the test, called SeptiCyte Rapid, for use in triaging COVID-19 patients who could be at greater risk for progressing to sepsis.

 

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