NEW YORK – The US Food and Drug Administration in December granted 510(k) marketing clearances to molecular tests for infectious diseases, an updated digital pathology system, and immunoassays for chronic diseases and drug testing.
Abbott Park, Illinois-based Abbott got the go-ahead for a molecular test for COVID-19. The firm's Alinity M SARS-CoV-2 is an RT-PCR assay for the qualitative detection of SARS-CoV-2 nucleic acids in nasopharyngeal or anterior nasal swab samples from patients with signs and symptoms of COVID-19. It is designed for use with the firm's automated Alinity M system, though the results should be used in conjunction with other clinical, epidemiological, and laboratory findings.
BioMérieux secured clearance for updates to a multiplex test that is used to identify in blood culture samples Gram-positive and Gram-negative bacteria, yeasts, and genetic markers of antimicrobial resistance, with results in about one hour. The French firm's BioFire Blood Culture Identification 2 (BCID2) Panel is a qualitative PCR-based assay for the simultaneous detection and identification of 43 targets, and it is designed for use on the company's BioFire FilmArray 2.0 and FilmArray Torch instruments. The test is performed on blood culture samples that have been identified as positive by a continuous monitoring blood culture system. Results should be interpreted in conjunction with Gram stain results. The updated clearance is for software updates that are designed to reduce the likelihood of false negative results.
BioMérieux also received a modified clearance for its BioFire FilmArray Tropical Fever Panel, which had previously been called the BioFire Global Fever Panel. The automated qualitative PCR test is used for the detection of bacterial, viral, and parasitic nucleic acids in EDTA whole blood samples from patients with signs or symptoms of acute febrile illness or suspected exposure to chikungunya virus, dengue virus serotypes 1-4, Leptospira species, and Plasmodium species. The changes reflect the product rebranding.
Sunnyvale, California-based Cepheid secured updated 510(k) clearance for a test that is used to aid the detection of Staphylococcus aureus and methicillin-resistant S. aureus in skin and soft tissue infections. The firm's Xpert MRSA/SA SSTI is an automated real-time PCR test for the qualitative detection of S. aureus and MRSA in swab samples, and the modified clearance allows the use of the test on the company's GeneXpert Infinity System in addition to the previous clearance for use with the GeneXpert Dx system. The test is used with other lab tests, such as microbiology culture, as well as clinical data.
Roche nabbed expanded 510(k) clearance for its Roche Digital Pathology Dx whole-slide imaging system, which can now be used with the firm's Ventana DP 600 slide scanner. The Basel, Switzerland-based firm's imaging system was cleared in June 2024 for use with the Ventana DP 200 slide scanner, and the system also includes Roche's digital pathology workflow software and the ASUS PA248QV display.
Waltham, Massachusetts-based Thermo Fisher Scientific secured the go-ahead for two antimicrobial susceptibility test powders. The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 µg/mL is used to aid the identification of resistance to ceftobiprole, which is used in the treatment of S. aureus infections. The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 µg/mL is used to aid the identification of resistance to linezolid, which is used in the treatment of certain Enterococcus faecium, E. faecalis, S. aureus, S. epidermidis, and S. haemolyticus infections.
Thermo Fisher subsidiary Microgenics, meanwhile, also gained clearance for the Alinity C Benzodiazepines Reagent Kit, a urine-based test for benzodiazepines and their metabolites. The immunoassay is designed for use on the Alinity C Analyzer System.
Werfen subsidiary Inova Diagnostics got the nod for a pair of immunoassays that are used to aid the diagnosis of primary and secondary antiphospholipid syndrome. The Barcelona, Spain-based firm's Aptiva APS IgG Reagent is used for the semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GPI) IgG autoantibodies in serum, and the Aptiva APS IgM Reagent is used for the semi-quantitative determination of aCL and aβ2GPI IgM autoantibodies in serum. Both tests are performed with Werfen's Aptiva analyzers, and the results should be used in conjunction with other lab findings.
Becton Dickinson got the green light for updates to a molecular test that is used to aid the diagnosis of vaginal infections. The Franklin Lakes, New Jersey-based firm's BD Vaginal Panel is an automated qualitative PCR assay that is used to identify bacteria that are associated with bacterial vaginosis, Candida species that are associated with vulvovaginal candidiasis, and Trichomonas vaginalis. The updates allow the selection of specific assay results to be reported based on orders received from a clinician.
Austin, Texas-based Nuclein gained FDA 510(k) clearance for an RT-PCR–based multiplex assay for the causes of respiratory infections. The Dash SARS-CoV-2 & Flu A/B Test is used with the company's Dash Rapid PCR Instrument for the simultaneous detection and differentiation of SARS-CoV-2, flu A, and flu B virus RNA in anterior nasal swab samples from patients with signs and symptoms of respiratory tract infection.
Lastly, Houston-based Healgen Scientific also gained clearance for two rapid lateral flow immunoassays that are used to detect the consumption of drugs of abuse. The Healgen Accurate Multi-Drug Urine Drug Screen Cup and Healgen Accurate Home Multi-Drug Urine Test Cup are used for the qualitative detection of analytes from 18 drugs. The test provides a preliminary result, and more specific chemical methods must be used to obtain confirmed positive results.
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