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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: JLW FDA class 2

    Radioimmunoassay, Thyroid-Stimulating Hormone

    Clinical Chemistry

    View full classification →

    This device is a radioimmunoassay system used to measure thyroid-stimulating hormone (TSH) in patient serum, used in the diagnosis and monitoring of thyroid disorders including hypothyroidism, hyperthyroidism, and pituitary dysfunction affecting thyroid regulation. It is classified as FDA Class 2, requiring 510(k) premarket notification, under 21 CFR 862.1690, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)
    Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
    ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
    Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
    Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
    Elecsys TSH
    AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer
    Lumipulse G TSH-III Immunoreaction Cartridges
    MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer
    Elecsys TSH assay, cobas e 801 Immunoassay analyzer
    Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control
    Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems
    IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4
    Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System
    ADVIA Centaur TSH3-Ultra
    ADVIA CENTAUR TSH
    FREND TSH (REAGENT CARTRIDGE)
    LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3
    MICT TSH
    FASTPACK TSH IMMUNOASSAY
    GSP INSTRUMENT AND GSP NEONATAL HTSH KIT
    ADVIA CENTAUR TSH3-ULTRA METHOD
    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM
    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM
    DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691
    GBI TSH NEONATAL SCREENING KIT
    ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300
    OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM
    DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE
    FASTPACK TSH IMMUNOASSAY
    MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
    TSH-CTK-3 IRMA
    THYRO TEST
    ACCESS HYPERSENSITIVE HTSH ASSAY
    CHEMWELL, ALSO KNOWN AS PROJECT 2900
    PRAXSYS RELIA TSH TEST
    SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)
    BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH)
    ACCUWELL TSH, MODEL KAW-TSH-960
    REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)
    BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003
    TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001
    THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY
    ABBOTT ARCHITECT TSH
    3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
    ABBOTT AXSYM 3RD GENERATION TSH ASSAY
    AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0
    AUTODELFIA NEONATAL HTSH L KIT (B077-112)
    AIA-PACK TSH 3RD-GEN ASSAY
    THYROTROPIN(TSH) ELISA

    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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