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Siemens Healthineers, Thermo Fisher, Becton Dickinson, Roche Gain FDA Clearances in June

NEW YORK – The US Food and Drug Administration in June granted 510(k) clearances for immunoassays, antimicrobial resistance tests, and other tests from firms including Siemens Healthineers, Thermo Fisher Scientific, Becton Dickinson, and Roche.

Siemens Healthineers got the green light for three assays: an automated immunoturbidimetric assay for the quantitative determination of the von Willebrand antigen in human plasma, a quantitative photometric assay for bilirubin in serum and plasma, and an anti-Müllerian hormone sandwich immunoassay. The Erlangen, Germany-based firm's vWF Ag assay is used with blood samples from patients ages 4 weeks and older with suspected or confirmed von Willebrand factor disorders. The test is designed for use on the Sysmex CS-2500 analyzer. The firm noted that the test results should be interpreted in conjunction with patient history, clinical presentation, and other laboratory findings.

Meantime, the Atellica CH Diazo Direct Bilirubin assay is for the detection of bilirubin formed during the destruction of red blood cells for the diagnosis and treatment of liver, hemolytic-hematological, and metabolic disorders including hepatitis and gall bladder block. That assay is designed for use on the Atellica CH Analyzer.

And Siemens' Advia Centaur Anti-Müllerian Hormone (AMH) sandwich immunoassay uses monoclonal anti-AMH antibodies and chemiluminometric detection to provide quantitative determination of AMH in human serum and plasma to help identify whether a patient has high, normal, or diminished ovarian reserves. The assay is designed for use with the Advia Centaur XP system and intended for use with other clinical and laboratory findings prior to starting fertility therapy.

Thermo Fisher Scientific also secured clearance for its Sensititre 20- to 24-Hour Haemophilus influenzae/Streptococcus pneumoniae MIC or breakpoint susceptibility system. The IVD product is for clinical susceptibility testing of fastidious isolates, specifically for imipenem-relebactam (Merck's Recarbrio) in a specific dilution range for testing fastidious H. influenzae.

Becton Dickinson got the go-ahead for a semi-quantitative agar diffusion test to determine the susceptibility of certain Gram-positive and Gram-negative bacteria to the antimicrobial lefamulin (Nabriva Therapeutics' Xenleta). The BD BBL Sensi-Disc Lefamulin 20 μg is used to determine the susceptibility of S. pneumoniae, Staphylococcus aureus, and H. influenzae.

Roche gained FDA clearance for an update to its molecular test for COVID-19 for use on its Cobas instruments, with changes intended to reduce false positives and implement an error flag for invalidated samples. The RT-PCR-based Cobas SARS-CoV-2 Qualitative test is used with nasal and nasopharyngeal specimens from patients with suspected COVID-19, and it is designed for use on the Cobas 5800, 6800, and 8800 instruments.

Also, BioMérieux got the green light for an updated version of a test to help identify the susceptibility of Gram-negative bacteria to levofloxacin. The Vitek 2 AST-Gram Negative Levofloxacin test is designed for use on the firm's Vitek 2 and Vitek 2 Compact instruments, and the latest version of the test adds reporting on susceptibility among Salmonella organisms.

MeMed got the nod for an update to an immunoassay to help differentiate bacterial from viral infections in patients with suspected sepsis. The MeMed BV automated semi-quantitative immunoassay has the ability to use venous whole-blood samples rather than only from serum. The test measures levels of TRAIL, IP-10, and CRP proteins in the blood or serum of adult or pediatric patients and returns results in about 15 minutes.

France-based Diagnostica Stago got the nod for updated versions of its Max Generation analyzers, the STA R Max 3 and STA Compact Max 3, which are used to aid in the diagnosis of coagulation abnormalities and monitoring of anticoagulant therapy. The fully automated analyzers are designed to provide clot-based, immunoturbidimetric, and colorimetric testing.

Lastly, Caire Diagnostics secured 510(k) clearance for an updated version of its Fenom Pro portable instrument for detecting concentrations of fractional exhaled nitric oxide in the breath of asthma patients using amperometric sensors. Increases in those concentrations are associated with inflammatory processes, and the Fenom Pro can be used to measure the effects of anti-inflammatory therapies in patients ages 6 years and older. The measurements are intended as an adjunct for clinical assessments.

For 360Dx's FDA 510(k) tracker, click here.