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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: CIC FDA class 2

    Cresolphthalein Complexone, Calcium

    Clinical Chemistry

    View full classification →

    The Cresolphthalein Complexone, Calcium test system (product code CIC) is an in-vitro diagnostic device used in clinical chemistry to measure calcium concentrations in serum or plasma using a cresolphthalein complexone (CPC) colorimetric method, a widely used photometric technique for routine calcium testing. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1145 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)
    DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)
    ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H
    SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
    SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS
    RAICHEM CALCIUM (OCPC) LIQUID REAGENT
    ATAC CALCIUM REAGENT AND ATAC CALIBRATOR
    WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002
    RANDOX CALCIUM
    BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02
    CALCIUM REAGENT
    COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
    CALCIUM REAGENT
    CALCIUM REAGENT
    IL TEST CALCIUM
    CALCIUM TEST ITEM NUMBER 65409
    OLYMPUS CALCIUM REAGENT
    MILES URINE CALCIUM METHOD
    OLYMPUS CALCIUM REAGENT
    CALCIUM-ARSENAZO III REAGENT SET
    CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL
    SYSTEMATE CALCIUM (EPOS APPLICATION) #65409
    SYNERMED CALCIUM REAGENT KIT
    CALCIUM ARSENAZO III REAGENT
    COBAS READY CALCIUM REAGENT
    CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432
    CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM)
    ABBOTT SPECTRUM(R) CALCIUM REAGENT
    CALCIUM TEST ITEM NUMBER: 65409
    IQ CALCIUM
    TECHNICON RA-100 SYSTEM CALCIUM METHOD
    CALCIUM TEST ITEM NUMBER: SR1009
    BIOTROL BILIRUBIN MONOREACTIF
    TECHNICON ASSIST(R) CALCIUM METHOD
    A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM
    CALCIUM
    CALCIUM, CATALOGUE NUMBER 122-20
    CALCIUM REAGENT SET
    CALCIUM ASSAY KIT, NUMBER 120-19
    PARAMAX CALCIUM REAGENT
    CRESOLPHTHALEIN COMPLEXONE, CALCIUM
    WAKO(TM) AUTOKIT CALCIUM
    MULTICHEM CALCIUM S0910
    CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD
    SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA)
    SIGMA'S CALCIUM PROCEDURE NO. 587
    SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA)
    CALCIUM TEST
    EASY-TEST CALCIUM (CA), ITEM NO. 67528/93
    UNIFAST CALCIUM TEST

    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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