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Abbott, Cepheid, BD, Roche, Others Nab FDA 510(k) Clearances in May

NEW YORK – A number of assays from Abbott were 510(k) cleared by the US Food and Drug Administration in May, while Cepheid, BD, and Roche also had tests get the green light from the agency last month, according to its website.

Abbott received FDA clearance for its Alinity i STAT High Sensitivity Troponin-I, a chemiluminescent microparticle immunoassay for quantitatively determining cardiac troponin in human plasma. The automated, two-step immunoassay is for use with Abbott's Alinity I system to help in diagnosing myocardial infarction.

Additionally, Abbott's Architect Toxo IgG assay received FDA clearance for the quantitative determination of IgG antibodies to Toxoplasma gondii in human serum and plasma. The chemiluminescent microparticle immunoassay is for aiding in the detection of immune status to T. gondii in individuals, including in women of childbearing age. It also is to help diagnose T. gondii infection but is not intended as a screening tool for blood, plasma, or tissue donors, the FDA said.

In May Abbott also received clearance for its Alinity m STI assay, which detects and differentiates between Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium from a swab or urine sample collected in a healthcare setting. 

The FDA also cleared Cepheid's Xpert GBS LB XC test, an automated in vitro diagnostic test for the qualitative detection of DNA from group B Streptococcus from vaginal-rectal swab specimens collected from pregnant women that are transported to the lab after enrichment in Lim broth. The test is for use with Danaher subsidiary Cepheid's GeneXpert Instrument Systems.

Meanwhile, Becton Dickinson received 510(k) clearance for the BD CTGCTV2 assay, which leverages automated DNA extraction and real-time PCR for the direct, qualitative detection of DNA from C. trachomatis (CT) N. gonorrhoeae (GC), and T. vaginalis (TV). The assay can be used to detect CT, GC, and TV in vaginal swab specimens and male and female urine samples, collected either by a patient or clinician. It may also be used to detect CT and GC DNA in endocervical swab and liquid-based cytology specimens in Hologic's ThinPrep PreservCyt Solution using an aliquot removed prior to processing for the ThinPrep Pap test.

The test was CE-IVD marked in December and can be used with the BD Max system or BD COR system.

Also in May, BD received 510(k) clearance for the MX molecular diagnostics module, which is part of the modular BD Cor.

Roche's Elecsys Testosterone II Immunoassay was 510(k) cleared for use with the firm's Cobas e 601 immunoassay analyzer to diagnose and treat disorders involving male sex hormones, including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males, hirsutism in females, and virilization in females due to tumors, polycystic ovaries, and adrenogenital syndromes.

Other tests and test systems that received FDA clearance last month include Angle, whose Parsortix cell sorting system was cleared for use in the isolation of circulating metastatic breast cancer cells for liquid biopsy testing.