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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: MID FDA class 2

    System, Test, Anticardiolipin Immunological

    Immunology

    View full classification →

    The Anticardiolipin Immunological Test System is an in vitro diagnostic device used to detect antibodies against cardiolipin, a phospholipid antigen, in patient serum or plasma, which is a key marker in the diagnosis of antiphospholipid syndrome and related autoimmune thrombotic conditions. It is classified as a Class 2 device under 21 CFR 866.5660, covering antigen and antibody test systems for autoimmune diseases, and requires 510(k) premarket notification. It falls within the Immunology specialty and is not flagged as an implant or life-sustaining device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Aptiva APS IgG Reagent; Aptiva APS IgM Reagent
    ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
    BIOPLEX 2200 APLS IGM
    QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
    IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
    BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
    ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
    CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
    HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
    EL-ACL SCREEN; EL-ACL IGM, IGG, IGA
    AESKULISA CARDIOLIPIN AGM
    REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139
    BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
    AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA
    REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
    MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT
    VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896
    REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001
    REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001
    APL IGA ELISA KIT
    QACA IGG/IGM ELISA KIT HRP
    VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696
    VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796
    VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596
    QACA IGG/IGM ELISA KIT
    DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T
    DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
    DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
    REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT
    MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
    DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
    ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
    DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500
    DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600
    REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT
    AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA
    AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA
    AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA
    ACL/APS FACS KIT
    ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT
    ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST
    ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT
    ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT
    THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM
    THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM
    THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F
    ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM
    ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM
    ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM
    ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS

    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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