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QuidelOrtho, BD, Roche, Immunexpress Gain 510(k) Clearances in December

NEW YORK – The US Food and Drug Administration in December granted 510(k) marketing clearances to an automated PCR instrument from QuidelOrtho, a fingertip blood collection device and test system from Becton Dickinson, and several infectious disease assays, among other tests.

QuidelOrtho got the agency's go-ahead for its Savanna real-time PCR-based automated molecular diagnostics instrument and a herpes simplex virus (HSV) assay designed for use on the instrument. The San Diego-based firm's Savanna instrument is a fully integrated, sample-to-result system for the analysis of up to 12 pathogens or targets, plus four controls. The Savanna HSV 1+2/VZV test panel is designed for the detection and differentiation of HSV-1, HSV-2, and varicella-zoster virus nucleic acids from cutaneous or mucocutaneous lesion specimens.

Franklin Lakes, New Jersey-based Becton Dickinson gained regulatory clearance for a fingertip blood collection device and test system developed in collaboration with Babson. The BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube is comprised of a capillary blood collection tube and a finger sleeve.

Becton Dickinson also secured an agency go-ahead for an update to a flu A/B test kit that is used in CLIA-waived healthcare facilities following hardware and software modifications to the analyzer used to interpret the test results. The BD Veritor System for Rapid Detection of Flu A+B CLIA-Waived Kit is a chromatographic lateral flow immunoassay that is used for the qualitative detection of flu A/B viral nucleoprotein antigens in nasal or nasopharyngeal swabs from symptomatic patients. It is designed for use on the BD Veritor Plus Analyzer.

Meantime, Basel, Switzerland-based Roche got a nod for a point-of-care molecular test for COVID-19. The Cobas SARS-CoV-2 Nucleic Acid Test for use on the Cobas Liat System is an automated RT-PCR test for the qualitative detection and identification of nucleic acids from the SARS-CoV-2 virus in nasopharyngeal and anterior nasal swabs from patients with signs and symptoms of upper respiratory tract infection or suspected COVID-19.

Immunexpress, which has offices in Seattle and Brisbane, Australia, gained clearance for ethylenediaminetetraacetic acid (EDTA) blood-compatible cartridges that are designed for use with the firm's molecular test to differentiate sepsis from infection-negative systemic inflammation. The SeptiCyte Rapid EDTA blood-compatible cartridges are used with the firm's RT-qPCR SeptiCyte Rapid test, which is used to evaluate patients during their first day following ICU admission by quantifying mRNA transcripts of host response genes PLA2G7 and PLAC8 and determining their relative expression levels. The test runs on Biocartis' Idylla instrument.

Brea, California-based Beckman Coulter got FDA clearance for modifications to two previously cleared immunoassays. The firm received a go-ahead for a change to the chemiluminescent substrate of a test used for the determination of cardiac troponin I levels in serum or plasma. The Access hsTnI immunoassay is designed for use on DxI Access Immunoassay Analyzers to aid in the diagnosis of myocardial infarction. The modification is a switch to the Lumi-Phos PRO substrate from the Lumi-Phos 530 substrate.

Beckman Coulter also got the green light for changes to the washing process for the Access hsTnI chemiluminescent immunoassay that is designed for use on the Access 2 Immunoassay System for the quantitative determination of cardiac troponin I levels in serum and plasma. The modifications are meant to reduce assay carryover between tests.

Also, Werfen subsidiary Instrumentation Laboratory got a nod for an assay used to identify factor IX deficiency and measure factor IX activity during replacement therapy. The firm's HemosIL Chromogenic Factor IX automated chromogenic assay is used for quantitative determination of factor IX activity in 3.2 percent citrated plasma, and it is designed for use with the firm's ACL TOP Family and ACL Top Family 50 Series instruments.

Halifax, Nova Scotia-based MedMira Laboratories secured 510(k) clearance for an HIV-2 claim for its rapid antigen tests for HIV-1/2 detection. The Reveal G4 Rapid HIV-1/2 Antibody Test is a vertical flow assay that uses gravity to move fluid through the assay, compared to the capillary reaction used to move fluid through lateral flow assays.

Sysmex America, a regional affiliate of Kobe, Japan-based Sysmex, got the go-ahead for its Sysmex XQ Series (XQ-320) Automated Hematology Analyzer. The quantitative multi-parameter analyzer is used in clinical laboratories to analyze venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant.

Lastly, Biomerica secured 510(k) clearance for an immunoassay used to aid in the diagnosis of Helicobacter pylori infection and evaluate infection status following treatment. The Irvine, California-based firm's Hp Detect Stool Antigen ELISA is an enzyme immunoassay used for qualitative detection of H. pylori antigen in stool or fecal samples. Patients may be retested four weeks or more following the completion of treatment.

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