NEW YORK – The US Food and Drug Administration granted 510(k) clearances in October for blood chemistry tests, antimicrobial susceptibility tests, vaginal infection assays, and infectious disease tests.
Waltham, Massachusetts-based Thermo Fisher Scientific nabbed 510(k) clearance for its Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, also called the Breakpoint Susceptibility System with ceftolozane-tazobactam in the dilution range of 0.03/4-64/4 µg/ml, to test for the susceptibility of fastidious isolates.
Thermo Fischer Scientific also got the go-ahead for a semi-quantitative agar diffusion test for antimicrobial resistance. The Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 is used to determine the susceptibility of Acinetobacter baumannii-calcoaceticus complex organisms to sulbactam-durlobactam.
BioMérieux received the green light for an update to its test for antimicrobial susceptibility of Streptococcus species to penicillin. The Marcy-l'Étoile, France-based firm's Vitek 2 AST-Streptococcus Penicillin quantitative test is updated to include FDA-recognized oral penicillin breakpoints, and previous performance data were obtained and evaluated using injected penicillin breakpoints. The test is designed for use with the Vitek 2 and Vitek 2 Compact instruments.
BioMérieux also gained clearance for an antimicrobial susceptibility test powder used to determine the minimum inhibitory concentration against microorganisms in agar media. Its ETest Sulbactam/Durlobactam is used for the determination of susceptibility of A. baumannii-calcoaceticus complex bacteria to sulbactam-durlobactam.
Danaher subsidiary Cepheid got the FDA's go-ahead for a molecular assay to aid in the diagnosis of vaginitis or vaginosis. The Xpert Xpress MVP is a real-time PCR assay for the detection of bacteria associated with bacterial vaginosis, Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis in self-collected vaginal swab samples from patients who are symptomatic for vaginitis or vaginosis. It is designed for use on Cepheid's GeneXpert Xpress instrument.
Cepheid also nabbed 510(k) clearance for a rapid, real-time RT-PCR COVID-19 assay. The Xpert Xpress CoV-2 Plus test is used for qualitative detection of viral RNA of the SARS-CoV-2 virus in nasopharyngeal swab and anterior nasal swab samples from patients with signs and symptoms of respiratory tract infection. The test is designed for use on Cepheid's GeneXpert instruments.
Abbott got three clearances in October for a series of blood tests that use the company's I-Stat CG8+ cartridge with the I-Stat 1 System. The Abbott Park, Illinois-based firm received one clearance for use of the cartridge to provide quantitative measurements of pH, partial pressure of oxygen, and partial pressure of carbon dioxide in blood samples for the diagnosis, monitoring, and treatment of respiratory, metabolic, and acid-base disturbances. It also secured clearance for use of the cartridge for the quantification of sodium and potassium in blood to aid the diagnosis or monitoring of electrolyte imbalances and diseases and conditions that manifest with high or low potassium levels. And the firm received clearance for use of the cartridge for quantification of ionized calcium and hematocrit in blood to aid in the diagnosis, monitoring, and treatment of conditions including parathyroid disease and chronic renal disease as well as the determination and monitoring of red cell volume status associated with conditions such as anemia and erythrocytosis.
And Saluggia, Italy-based DiaSorin nabbed clearance for an assay to detect previous infection with the virus that causes chickenpox (varicella). The Liaison VZV IgG HT is a chemiluminescent immunoassay for the qualitative detection of IgG antibodies to varicella-zoster virus in serum, dipotassium EDTA plasma, lithium heparin plasma, and sodium heparin plasma samples. It is designed for use on the company's Liaison XL analyzer.