NEW YORK ─ Though US Food and Drug Administration Emergency Use Authorizations associated with COVID-19 continued apace in May, the agency also granted 510(k) clearances for tests from a number of in vitro diagnostic companies, including Siemens Healthineers, Hologic, DiaSorin, BioMérieux, and others, according to the FDA's website.
The agency granted clearance to Erlangen, Germany-based Siemens Healthineers for its Advia Centaur Vitamin D Total assay for use on the Advia Centaur system to measure total 25-OH vitamin D to determine vitamin D sufficiency.
It gave the nod to Marlborough, Massachusetts-based Hologic for its Aptima Combo 2 Assay. The Aptima Combo 2 Assay is a nucleic acid test that uses target capture for the detection and differentiation of ribosomal RNA from Chlamydia trachomatis and Neisseria gonorrhoeae,running on Hologic's Panther and Tigris systems. The clearance permits a change in the formulation of a probe reagent in the Aptima Combo 2 assay to detect variants of Chlamydia trachomatis that have emerged recently.
Saluggia, Italy-based DiaSorin nabbed a clearance for its Liaison Folate chemiluminescent immunoassay to measure levels of folic acid used in the diagnosis of anemia. The test runs on the Liaison XL analyzer.
Marcy l'Etoile, France-based BioMérieux got the go-ahead for its Etest Plazomicin, a manual technique for the determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. A predefined antibiotic gradient is used to determine the minimum inhibitory concentration (MIC) of antimicrobial agents acting against microorganisms in agar media. Plazomicin (Cipla's Zemdri) is active against select bacteria.
Uppsala, Sweden-based Phadia, part of Thermo Fisher Scientific, got the nod for its ImmunoCap Allergen o215, Component nGal-alpha-1,3-Gal (alpha-Gal) Thyroglobulin, bovine test to detect IgE-mediated red-meat hypersensitivity due to alpha-Gal sensitization. The assay is used with the firm's ImmunoCAP Specific IgE assay and runs on the Phadia 250 instrument.
Tokyo-based Fujirebio Diagnostics received clearance for its Lumipulse chemiluminescent enzyme immunoassay to measure CA19-9, running on the Lumipulse G system. The assay is used to manage patients diagnosed with cancer of the exocrine pancreas who have detectable levels of CA19-9.