BEUDAMED
    Product Code: NQD FDA class 2 21 CFR 866.5270

    Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

    Immunology

    The cardiac C-reactive protein (CRP) antigen, antiserum, and control test is an immunology in vitro diagnostic device used to measure C-reactive protein levels specifically for the purpose of making cardiac risk assessments and predicting cardiovascular disease risk. It is classified as FDA Class 2 under regulation 866.5270 in the Immunology specialty, requiring 510(k) premarket notification. Product code NQD is eligible for third-party review and is not an implant or life-sustaining device.

    View on FDA
    510(k)s
    19
    FEI Numbers
    24
    Registration Numbers
    24
    Unique Applicants
    11
    Years Active
    22

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    Basic Information

    Product Code
    NQD
    Device Class
    FDA class 2
    Regulation Number
    866.5270
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 19 510(k) clearances via K numbers.

    K Number Device Name
    K260026 Tina-quant Cardiac high sensitivity CRP III
    K233242 Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
    K212559 CardioPhase® hsCRP
    K173833 CRP Vario
    K081294 ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS
    K071002 IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT
    K070626 SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT
    K071017 IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)
    K062924 STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK
    K063057 IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP
    K061802 DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH
    K060369 STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK
    K053603 C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS
    K053109 DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE
    K051564 OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH
    K042485 TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)
    K041799 VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS
    K041668 OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
    K033908 N HIGH SENSITIVITY CRP

    FEI Numbers

    This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.