11/01/2024, 10:26 QuidelOrtho, BD, Roche, Immunexpress Gain 510(k) Clearances in December | 360Dx

QuidelOrtho, BD, Roche, Immunexpress Gain 510(k)

Clearances in December
Jan 10, 2024 | staff reporter

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 HsTnl 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.

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11/01/2024, 10:26 QuidelOrtho, BD, Roche, Immunexpress Gain 510(k) Clearances in December | 360Dx

Beckman Coulter also got the green light for changes to the washing process for an assay used to
aid in diagnosing a heart attack. The Access hsTnI chemiluminescent immunoassay is used 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.

Filed Under Regulatory News & FDA Approvals North America Europe QuidelOrtho

Becton Dickinson Beckman Coulter Roche HIV coronavirus FDA 510(k)

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