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FDA Issues Clearances in April to Zeus Scientific, BioMérieux, Roche, Abbott, Others

NEW YORK ─ The US Food and Drug Administration granted 510(k) clearances in April for tests from BioMérieux, Roche, Zeus Scientific, Abbott, and others, according to the agency's website.

BioMérieux obtained clearance for the Vitek 2 AST-Gram Negative Ciprofloxacin assay, a qualitative antimicrobial susceptibility test for Gram-negative bacilli used with the BioMérieux Vitek 2 and Vitek 2 Compact systems. The test determines the susceptibility of the Gram-negative bacilli to ciprofloxacin, an antibiotic used to treat numerous bacterial infections.

The FDA also cleared an updated version of the ePlex Blood Culture Identification Gram-Negative Panel developed by Roche's GenMark Diagnostics business. The test had previously received 510(k) clearance, and the update reflects a change to the panel's design and limit of detection. Studies conducted to validate the design change include the addition of oligonucleotides to improve robustness and inclusivity of the panel's E. coli, Citrobacter, Enterococcus, and P. aeruginosa assays, the FDA said.

Zeus Scientific obtained clearance for the Zeus IFA ANA Hep-2 Test, an immunofluorescence assay to detect IgG anti-nuclear antibodies in serum. Used with other serological tests and clinical findings, the detection of anti-nuclear antibodies helps to diagnose systemic lupus erythematosus and other systemic rheumatic diseases. Either a manual fluorescence microscope or the Zeus dIFine instrument can be used to detect the IgG anti-nuclear antibodies. The Zeus instrument, which got the green light along with the test, consists of a fluorescent microscope and software that acquires, interprets, stores, and displays digital images of stained immunofluorescence slides.

Abbott obtained clearance in April for its Alinity m STI Assay to detect and differentiate between Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium from a swab or urine sample collected in a healthcare setting.

Other tests which received FDA clearance last month include a homogeneous enzyme immunoassay from Psychemedics to detect the illegal drug phencyclidine in hair. Meanwhile, Co-Innovation Biotech got the green light for its over-the-counter One Step Human Chorionic Gonadotropin (hCG) Test Strip, a visual immunochromatographic assay to detect hCG in urine for the early detection of pregnancy.