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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: JIT FDA class 2

    Calibrator, Secondary

    Clinical Chemistry

    View full classification →

    This device is a secondary calibrator used in clinical chemistry laboratory systems to transfer calibration values from a primary reference standard to working analytical instruments, enabling consistent and accurate measurement across testing platforms. It is classified as FDA Class 2, posing moderate risk and requiring 510(k) premarket clearance. The product code is JIT, regulated under 21 CFR 862.1150, and assigned to the Clinical Chemistry medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    VITROS Immunodiagnostic Products Insulin Calibrators
    CalSet IGF-1
    Abbott ARCHITECT Free T3
    Lumipulse G Progesterone-N Calibrators
    Lumipulse G FSH-N Calibrators
    Lumipulse G LH Calibrators
    Lumipulse G Prolactin
    DC-UIBC-CAL
    Lumipulse G E2-III Calibrators
    ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
    ST AIA-PACK hsE2 Calibrator Set
    ST AIA-PACK PROG III Calibrator Set
    Elecsys Progesterone III CalSet
    Abbott ARCHITECT Total T4 Calibrators
    UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator
    Elecsys T-Uptake Calset
    ST AIA-PACK PROG II Calibrator Set
    RANDOX ALDOLASE CALIBRATION SERUM
    Elecsys Estradiol III CalSet
    DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
    ACE CALIBRATOR
    BICARBONATE CALIBRATOR
    CA 125 II CALSET II
    ST AIA-PACK C-PEPTIDE II CALIBRATOR SET
    PATHFAST CTNL CALIBRATORS
    LP(A) CALIBRATORS, AND LP(A) CONTROLS
    PATHFAST CK-MB-II CALIBRATORS
    DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
    DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)
    ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL
    DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH
    DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2
    DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL
    ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
    ST AIA-PACK DHEA-S CALIBRATOR SET
    ABBOTT ARCHITECT LH CALIBRATORS
    ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491
    DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H
    ENZYME II CALIBRATOR
    ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5
    DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL
    DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS
    STA-HYBRID HEP CALIBRATOR
    DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D
    ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810
    ABX PENTRA TPU CAL, MODEL A11A01898
    DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350
    LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623
    DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR
    ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10

    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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