NEW YORK ─ The US Food and Drug Administration granted 510(k) clearances in November for tests from Becton Dickinson, Siemens Healthineers, Abbott Laboratories, BioMérieux, and others, according to the agency's website.
Becton Dickinson got the green light for its Kiestra IdentifA specimen preparation system along with the BD Kiestra Laboratory Automation Solution. The system prepares specimen targets for the Bruker MALDI Biotyper CA System, used to diagnose bacterial and fungal infections.
Meanwhile, BioMérieux obtained FDA clearance for the BioFire COVID-19 Test 2, a multiplex RT-PCR assay, with the BioFire FilmArray 2.0 and BioFire FilmArray Torch systems. The BioFire COVID-19 Test 2 detects SARS-CoV-2 RNA in nasopharyngeal swabs from symptomatic individuals.
The diagnostic company also got the go-ahead for its ETest Fosfomycin, a manual assay used to determine the antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. Fosfomycin, an antibiotic, is active against the Gram-positive and Gram-negative aerobic microorganisms Escherichia coli and Enterococcus faecalis, and the ETest can be used to determine the minimum inhibitory concentration of fosfomycin against them.
The FDA granted clearance to Tosoh Bioscience for its Tosoh ST AIA-Pack BNP assay with the firm's Tosoh AIA System Analyzers. The assay is used to diagnose heart failure in patients presenting to the emergency department with clinical suspicion of new onset heart failure, acutely decompensated heart failure, or exacerbated heart failure.
Siemens Healthineers obtained clearance for its Atellica CH Enzymatic Creatinine 3 (ECre3) assay for the quantitative determination of creatinine in human serum, plasma, and urine. The assay is used to diagnose renal diseases and monitor renal dialysis while running on the firm's Atellica CH analyzer.
Abbott Laboratories' diagnostic division in Ireland got the nod for its Albumin BCG2 assay for the quantitation of albumin in serum or plasma while running on the company's Architect c system. The assay is used to diagnose diseases that mainly involve the liver and kidneys.
Immunexpress received 510(k) clearance for its SeptiCyte Rapid sepsis assay, which distinguishes sepsis from noninfectious systemic inflammation in patients suspected of having sepsis.