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CDC, Abbott, Roche, BioMérieux Get FDA 510(k) Clearances in June

NEW YORK – The US Centers for Disease Control and Prevention's orthopoxvirus test received 510(k) clearance from the US Food and Drug Administration last month, as well as a cholesterol test from Abbott, an antimicrobial susceptibility test from BioMérieux, and a fertility test from Roche, according to the FDA's website.

The FDA cleared the CDC's Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set, which is intended to detect orthopoxvirus DNA from human pustular or vesicular rash specimens and viral cell culture lysates that have been submitted to a Laboratory Response Network reference lab. Non-variola orthopoxvirus DNA includes vaccinia, cowpox, monkeypox, and ectromelia viruses, but the test doesn't differentiate vaccinia or monkeypox from other viruses. The test previously received clearance in 2018, and with the exception of some reagents and instrumentation, the device description remains unchanged from the CDC's 2018 submission, the FDA noted. 

Roche also nabbed clearance for its Elecsys AMH test for anti-Müllerian hormone in human serum and lithium heparin plasma. The determination of the hormone is used to assess the ovarian reserve in women before starting fertility therapy, and the electrochemiluminescence immunoassay is intended to distinguish between women with high ovarian reserve and women with normal or diminished ovarian reserve. It runs on the Cobas E immunoassay analyzers.

The test originally received FDA clearance in 2017 but was updated to mitigate the potential interference of biotin, according to the clearance document. 

Meantime, Abbott nabbed clearance for its Cholesterol2 test for the quantitation of cholesterol in human serum or plasma, which runs on the firm's Architect C system. The clinical chemistry assay is intended to help diagnose and treat disorders that involve excess cholesterol in the blood, as well as lipid and lipoprotein metabolism disorders.

BioMérieux's Vitek 2 AST-Gram Negative Omadacycline test was also cleared by the FDA. The quantitative assay is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the company's Vitek 2 and Vitek 2 Compact Systems. 

Lastly, Sysmex received US Food and Drug Administration clearance in June for the addition of residual white blood cell counting to its XN-10 Automated Hematology Analyzer with Blood Bank mode.