Skip to main content
Premium Trial:

Request an Annual Quote

Siemens Healthineers, Thermo Fisher Scientific, DiaSorin and Others Get 510(k) Clearances in October

NEW YORK – The US Food and Drug Administration cleared in vitro diagnostic tests and systems in October from Siemens Healthineers, Thermo Fisher Scientific, DiaSorin, Microbiologics, and others, according to the agency's website.

Siemens Healthineers received clearance for the Atellica IM Total hCG assay for the quantitative measurement of human chorionic gonadotropin in human serum or plasma, using the firm's Atellica IM Analyzer. Human chorionic gonadotropin measurements are used to detect pregnancy.

Thermo Fisher Scientific received clearance for its Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 µg/mL. MIC, also known as the minimum inhibitory concentration, is the lowest concentration of a drug that prevents visible growth of a bacterium.

The FDA cleared DiaSorin to market its Liaison XL Zika Capture IgM II for the qualitative detection of Zika virus IgM antibodies in human sera collected from people meeting US Centers for Disease Control and Prevention Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria. The assay is not indicated for testing blood or plasma donors, and the test must be done on DiaSorin's Liaison XL analyzer, the FDA said. Further, DiaSorin received clearance for its Liaison XL Zika Capture IgM II Control Set to monitor the performance of the Liaison XL Zika Capture IgM II assay.

In a separate clearance, the FDA gave the nod to Diasorin for its Liaison Vitamin B12 chemiluminescent immunoassay used for the quantitative measurement of vitamin B12 in human serum, serum-separating tube specimens, and lithium heparin plasma, running on the Liaison XL analyzer.

Microbiologics received clearance to market the Cepheid Xpert Respiratory Control Panel, which contains cultured viruses inactivated by chemical or radiological treatments. The control panel is an external assayed positive and negative quality control. It monitors the performance of laboratory nucleic acid testing procedures for the qualitative detection of influenza A (H1N1) virus, influenza A (H3N2) virus, influenza B virus, and respiratory syncytial virus A. The tests are done using Danaher's Cepheid Xpert Xpress Flu/RSV assay, running on Cepheid's GeneXpert instrument.

The FDA cleared iXensor to market its PixoTest POCT Analyzer and PixoTest A1c Test Kit for the quantitative measurement of glycated hemoglobin (HbA1c) in fingerstick capillary and venous whole blood samples. The analyzer and kit monitor long-term glycemic control in people previously diagnosed with diabetes mellitus.

Fujirebio Diagnostics got the nod to market its Lumipulse G CA19-9-N chemiluminescent enzyme immunoassay for the quantitative measurement of CA19-9 in human serum or plasma, running on the firm's Lumipulse G System. The assay is used to help manage patients diagnosed with cancer of the exocrine pancreas who have detectable levels of CA19-9 at some point in the disease process.

Lin-Zhi International obtained clearance for the LZI Methadone II Enzyme Immunoassay used for the qualitative and semi-quantitative determination of methadone in human urine.

Also, Shenzhen Bioeasy Biotechnology received FDA's OK to market its Bioeasy Marijuana Test Dip Card 40; Bioeasy Marijuana Test Dip Card 20; Bioeasy Marijuana Test Strip 40; and Bioeasy Marijuana Test Strip 20. Bioeasy Marijuana Test Dip Card 40 is a lateral flow immunochromatographic assay for the qualitative detection of marijuana in human urine at the cutoff concentrations of 40 ng/mL. The test provides only preliminary test results and a more specific alternative chemical method must be used to obtain a confirmed analytical result, the FDA said.

Horiba receive clearance to market its Yumizen C1200 CRP reagent for the quantitative measurement of C-reactive protein in human serum and plasma based on an immunoturbidimetric assay. CRP is used to evaluate conditions associated with inflammation.

The FDA cleared GeneOhm Sciences Canada to market the BD Max Vaginal Panel running on the BD Max System. The vaginal panel is a qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with bacterial vaginosis, Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis.  

NG Biotech received clearance for the NG-Test Carba 5 multiplex immunochromatographic assay to detect one or more of five common types of carbapenemase enzymes in bacterial colonies.

The FDA cleared Alpco to market its Calprotectin Chemiluminescence ELISA for the quantitative measurement of fecal calprotectin, a neutrophilic protein marker of intestinal mucosal inflammation. The test is used to diagnose inflammatory bowel disease (IBD), specifically Crohn’s disease and ulcerative colitis, and to differentiate IBD from irritable bowel syndrome.

MRIGlobal got the go-ahead to market the Applied Biosystems Bacillus anthracis Detection Kit, a real-time PCR test used to target DNA sequences for Bacillus anthracis.

In other regulatory news in October, the FDA cleared Ortho Clinical Diagnostics to market its Ortho Sera suite of reagents that enable extended antigen phenotyping.

OraSure Technologies for the nod to market its rapid lateral flow immunoassay to detect Ebola virus infection, and Beckman Coulter was cleared to market its DxA 5000 total laboratory automation solution. Sekisui Diagnostics received clearance and a CLIA waiver for its Acucy Influenza A&B test, and Cepheid obtained clearance for its Xpert BCR-ABL Ultra test for monitoring disease burden in patients with chronic myeloid leukemia.