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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: MSV FDA class 2

    System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

    Immunology

    View full classification →

    A Beta-2-Glycoprotein I (B2-GPI) Antibody Test System is an in vitro diagnostic device that detects and measures antibodies against beta-2-glycoprotein I in serum, an important marker for antiphospholipid syndrome, a condition associated with thrombosis and recurrent pregnancy loss. It is FDA Class 2, requiring 510(k) clearance, with product code MSV under 21 CFR 866.5660 in the Immunology specialty. The device is not an implant and is not life-sustaining.

    510(k) Clearances

    45 matches
    K Number
    Device Name
    EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
    ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA
    QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls
    QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS.
    ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
    HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS
    THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR
    IGG ANTI-ATHEROX TEST KIT
    AESKULSKA BETA2-GLYCO-A
    VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996
    VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896
    VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096
    VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796
    IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA
    IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA
    REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
    DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
    AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA
    AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA
    AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA
    QAB2A IGG ELISA KIT HRP
    QAB2A IGM ELISA KIT HRP
    QAB2A IGG ELISA KIT
    DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
    DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
    REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT
    REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
    REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT
    BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT.
    BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT
    BINDAZYME ANTI-B2 SCREEN EIA TEST KIT.
    BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT
    VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT
    VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT
    VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT
    REAADS IGA ANTI-B2GP 1 TEST KIT
    REAADS IGM ANTI-B2GP1 TEST KIT
    REAADS IGG ANTI-B2GPI TEST KIT
    SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY
    QUANTA LITE B2 GPI SCREEN
    EL-B2GP1SCR
    THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR
    QUANTA LITE B2GPI IGM
    QUANTA LITE B2 GPI IGA
    QUANTA LITE B2GPI IGG

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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