NEW YORK – The US Food and Drug Administration in November granted 510(k) marketing clearances to antibiotic susceptibility tests, updated molecular tests for infectious diseases, and a pair of chronic disease tests, among other diagnostic tools.
Thermo Fisher Scientific got the green light for an updated test to determine the susceptibility of bacteria to the antibiotic daptomycin. The Waltham, Massachusetts-based firm's Sensititre 18-24-hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 µg/mL is a quantitative growth-based test that is used to identify susceptibility to the drug among non-fastidious Gram-negative isolates of Enterobacteriaceae, Pseudomonas aeruginosa, and other non-Enterobacteriaceae, as well as non-fastidious Gram-positive isolates of Staphylococcus species, Enterococcus species, and beta-hemolytic streptococci other than Streptococcus pneumoniae. The clearance is an update to a previous clearance with an expanded claim to include Enterococcus faecium and FDA-updated breakpoints for other Enterococcus species.
French firm BioMérieux got the go-ahead for software updates for two assays that are used to detect and identify the causes of suspected lower respiratory tract infections. The firm's BioFire FilmArray Pneumonia Panel and BioFire FilmArray Pneumonia Panel Plus are multiplexed assays for the identification of nucleic acids from pathogens and antimicrobial resistance genes in sputum, endotracheal aspirates, and bronchoalveolar lavage samples. The updates are intended to mitigate issues with false-positive coronavirus assay results. Both tests are designed for use with the firm's PCR-based FilmArray 2.0 or FilmArray Torch instruments.
The company also received an updated clearance for its BioFire FilmArray Gastrointestinal Panel to include in its labeling new clinical data and the results of an evaluation of the potential risk of false positive results for the Norovirus GI/GII assay target. The test is a multiplex assay for the qualitative detection and identification of nucleic acids from bacteria, viruses, and parasites in stool samples from individuals with signs and symptoms of gastrointestinal infection. The GI assay also is designed for use with the company's PCR-based FilmArray 2.0 and Torch instruments.
Sunnyvale, California-based Cepheid, meanwhile, also secured an updated clearance for a molecular test that is used to determine whether bacteria are resistant to the antibiotic vancomycin. The firm's Xpert vanA is an automated PCR-based test for the qualitative detection of the vanA gene sequence in rectal swab samples, and the updated clearance allows the test to be used with Cepheid's GeneXpert Instrument Systems family that includes both the GeneXpert Dx System that was identified in the original clearance in 2009 and the company's newer GeneXpert Infinity System.
Nova Biomedical received 510(k) clearance last month for a urine-based test for albumin and creatinine, a blood-based test for HbA1c, and a cartridge-based point-of-care instrument that is used to perform those tests. The Waltham, Massachusetts-based firm's Nova Allegro UACR Assay is used for the quantitative determination in a urine sample of albumin, creatinine, and the albumin-to-creatinine ratio to aid the early diagnosis of nephropathy. The firm's Nova Allegro HbA1c Assay, meanwhile, is used for the quantitative determination of HbA1c in whole blood from a fingerstick sample and the calculation of estimated average glucose. The results are used for the monitoring of blood glucose and metabolic control in individuals with diabetes mellitus.
The tests are designed for use with the company's Nova Allegro Analyzer, which was also granted 510(k) clearance.
Meanwhile, medical Electronic Systems, which has offices in California, Belgium, and India, gained clearance from the agency for a smartphone-based home-use test for semen analysis. The YO Home Sperm Test (YO 3.0) is used for algorithm-based quantitative analysis of sperm concentration and motility.
Lastly, China-based Hangzhou Clongene Biotech got the go-ahead for a pair of lateral flow assays that are used to detect fentanyl consumption. The firm's Clungene Fentanyl Home Test Cassette and Clungene Fentanyl Test Cassette are used for the qualitative detection of fentanyl in urine.
For 360Dx's FDA 510(k) tracker, click here.