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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: CEW FDA class 2

    Radioimmunoassay, Parathyroid Hormone

    Clinical Chemistry

    View full classification →

    The Parathyroid Hormone Radioimmunoassay is a clinical chemistry device that uses radioisotope-based immunoassay techniques to measure parathyroid hormone (PTH) levels in blood, used in the diagnosis and management of hyperparathyroidism, hypoparathyroidism, and calcium metabolism disorders. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CEW, regulated under 21 CFR 862.1545, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Elecsys PTH , Elecsys PTH STAT
    Access Intact PTH
    VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
    Lumipulse G whole PTH
    ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
    IDS-iSYS Intact PTHN
    LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers
    ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY
    LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS
    ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
    IDS-ISYS INTACT PTH
    VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT
    ROCHE ELECSYS PTH TEST SYSTEM
    ST AIA-PACK INTACT PTH ASSAY
    ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01
    ELECSYS PTH TEST SYSTEM
    ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
    MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002
    MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
    IMMULITE/IMMULITE 1000 TURBO INTACT PTH
    TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013
    WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014
    TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
    WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002
    NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022
    NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY
    LIAISON N-TACT PTH
    NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040
    CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001
    PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84)
    IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
    AXSYM INTACT PTH, MODEL 2G06
    NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY
    IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6
    IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6
    TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600
    WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056
    FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT
    ELECSYS PARATHYROID HORMONE TEST SYSTEM
    IMMULITE TURBO INTACT PTH, MODEL LSKPTZ
    SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA
    ACTIVE INTACT PTH
    AQUALITE INTACT PTH
    NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT
    CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT
    INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)
    INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY)
    ACTIVE INTACT PTH ELISA
    ELSA-PTH
    GAMMA-BCT INTACT PTH

    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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