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Re: K254059
Trade/Device Name: Access anti-HBc IgM
Regulation Number: 21 CFR 21 CFR 866.3173
Classification Name:** Qualitative Hepatitis B virus antibody assay
Classification Regulation: 21 CFR 866.3173

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The Access anti-HBc IgM assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of IgM antibodies to hepatitis B virus core antigen (anti-HBc IgM) in human pediatric (3 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2) EDTA, tripotassium (K3) EDTA, sodium citrate, acid citrate dextrose (ACD), and citrate phosphate dextrose (CPD)] using the DxI 9000 Access Immunoassay Analyzer.

The Access anti-HBc IgM assay results may be used as an aid in the laboratory diagnosis of acute or recent hepatitis B virus (HBV) infection in individuals with signs and symptoms of hepatitis, when used in conjunction with other serological and clinical information.

The Access anti-HBc IgM assay is for use on the DxI 9000 Access Immunoassay Analyzer only.

This assay is not intended for the screening of blood, plasma, and cell or tissue donors.

Device Description

The Access anti-HBc IgM assay is a two-step enzyme immunoassay. Paramagnetic particles coated with anti-human IgM monoclonal antibody and prediluted sample are added to a reaction vessel. After incubation, material bound to the solid phase is held in a magnetic field while unbound materials are washed away. HBc antigen complexed to anti-HBc monoclonal antibody alkaline phosphatase conjugate is added and the conjugate binds to the IgM antibodies captured on the particles. A second separation and wash step remove unbound conjugate.

A chemiluminescent substrate is then added to the vessel and light generated by the reaction is measured with a luminometer. The light production is compared to the cutoff value defined during calibration of the instrument. The qualitative assessment is automatically determined from a stored calibration.

The Access anti-HBc IgM Calibrator is used to establish calibration (determine the cutoff value) for the Access anti-HBc IgM assay. By comparing the light intensity generated by a sample to the cutoff value, the presence or absence of IgM antibodies to hepatitis B virus core antigen (anti-HBc IgM) in the sample is determined.

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K Number

K253687

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Device Name

Access anti-HBc Total (C39432) Access anti-HBc Total Calibrator (C39433) Access anti-HBc Total QC (C39434)

Manufacturer

Beckman Coulter, Inc.

Date Cleared