NEW YORK (360Dx) – During May, the US Food and Drug Administration cleared in vitro diagnostic tests and systems from Siemens Healthineers, Roche Diagnostics, PerkinElmer, BioMérieux, and others, according to the agency's website.
Erlangen, Germany-based Siemens Healthineers received clearance for its Dimension Exl High-Sensitivity Troponin I Assay used to diagnose acute myocardial infarction running on its Dimension Exl integrated chemistry system.
Additionally, the FDA cleared Roche Diagnostics' Cobas u 601 urinalysis test system used to measure urine analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, color, and erythrocytes. Clinicians use the measurements to evaluate renal, urinary, hepatic, and metabolic disorders.
Roche, based in Rotkreuz, Switzerland, also received clearance for its Cobas TV/MG test running on its Cobas 6800/8800 systems, and for the Cobas TV/MG Positive Control Kit and Cobas Buffer Negative Control Kit.
The Cobas TV/MG assay uses real-time PCR for the detection of trichomonas vaginalis DNA and mycoplasma genitalium DNA in a range of samples, including urine, vaginal swab specimens self-collected in a clinical setting, clinician-collected vaginal swab specimens, and endocervical specimens.
Waltham, Massachusetts-based PerkinElmer got clearance for its NeoLSD Msms Kit on the QSight 210 MD system, which measures the activity of a number for enzymes in dried blood spots — acid β-glucocerebrosidase, acid-sphingomyelinase, acid α-glucosidase, β-galactocerebrosidase, α-galactosidase A, and α-L-iduronidase in dried blood spots. The analysis of enzymatic activity is used in the screening of newborn babies for lysosomal storage disorders.
Maine Molecular Quality Controls, based in Saco, Maine, received clearance for its FilmArray Pneumonia/Pneumonia plus Control. It's used as an external positive and negative assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures in detecting a range of bacteria, antimicrobial resistance genes, and viruses.
The FilmArray Pneumonia/ Pneumonia plus Control is composed of synthetic DNA and RNA and is for use solely with BioMérieux's FilmArray Pneumonia Panel and FilmArray Pneumonia Panel plus assays. The product is not intended to replace the internal controls that the panel manufacturer provides with the test system, the FDA said.
Marcy-l'Étoile-based BioMérieux's got regulatory clearance for its Bact/Alert MP Reagent System for use with the firm's Bact/Alert 3D Mycobacteria Detection Systems. The reagent and detection systems are used to detect mycobacteria from sterile body specimens other than blood and from decontaminated clinical specimens.
The FDA also granted clearance to Boston, Massachusetts-based Haemonetics for its Teg 6s Hemostasis System used to provide an indication of the hemostasis state of a venous blood sample.
During May, the FDA also cleared the DiaSorin Molecular Simplexa VZV Direct assay for detecting varicella-zoster virus; Danaher's Leica Biosystems' Aperio AT2 DX System; Inova Diagnostic's Quanta Flash Rheumatoid Factor IgM and Quanta Flash RF IgA assays; and InBios International's ZIKV Detect 2.0 IgM Capture ELISA.
Hologic received clearance for two of its infectious disease assays used in the detection of common causes of vaginitis, and the firm, in addition to Danaher's Cepheid, got clearance for assays that detect chlamydia and gonorrhea for use with extragenital specimens — from the throat and rectum.
In a busy month for clearances, Qiagen got the nod for its QiaStat-Dx syndromic testing system and multiplex respiratory pathogen panel; True Diagnostics was granted clearance for its VeriClear Digital Early Result pregnancy test; and GenePOC was granted clearance for a small molecular diagnostic panel test to detect carbapenem drug resistance.