NEW YORK ─ The US Food and Drug Administration granted 510(k) clearances in January for tests from Ortho Clinical Diagnostics, Hangzhou AllTest Biotech, Carolina Liquid Chemistries, and 23andMe, according to the agency's website.
Raritan, New Jersey-based Ortho obtained clearance for its Vitros Immunodiagnostic Products CK-MB Reagent Pack for the quantitative measurement of creatine kinase myocardial band in serum and plasma on the firm's Vitros 3600 Immunodiagnostic System. Measurements of creatine phosphokinase and its isoenzymes are used to diagnose myocardial infarction and muscle diseases such as Duchenne muscular dystrophy.
China-based Hangzhou AllTest Biotech obtained FDA clearance for the Alltest Pregnancy Rapid Combo Test Cassette, a rapid chromatographic immunoassay that detects human chorionic gonadotropin in urine or serum for the early diagnosis of pregnancy.
Meanwhile, Carolina Liquid Chemistries, based in Greensboro, North Carolina, was granted clearance for its Cocaine and Cocaine Metabolite Enzyme Immunoassay Test System, which runs on the firm's CLC6410 automated clinical chemistry analyzer to rapidly screen for benzoylecgonine, a cocaine metabolite, in urine. The assay provides a preliminary result, and an alternative chemical method must be used to obtain confirmation, the FDA said.
Also, 23andMe announced it received 510(k) clearance for a direct-to-consumer genetic risk report for hereditary prostate cancer.