BEUDAMED
    Product Code: JHX FDA class 2 21 CFR 862.1215

    Fluorometric Method, Cpk Or Isoenzymes

    Clinical Chemistry

    Fluorometric Method for CPK or Isoenzymes is a clinical chemistry test system that uses fluorescence detection to measure creatine kinase and its isoenzyme fractions, supporting diagnosis of myocardial infarction and skeletal muscle disorders. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is JHX, regulated under 21 CFR 862.1215, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    48
    FEI Numbers
    31
    Registration Numbers
    31
    Unique Applicants
    29
    Years Active
    47

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    Basic Information

    Product Code
    JHX
    Device Class
    FDA class 2
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 48 510(k) clearances via K numbers.

    K Number Device Name
    K234005 Access CK-MB
    K212648 VITROS Immunodiagnostic Products CK-MB Reagent Pack
    K163462 AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
    K120326 AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE
    K081360 PATHFAST CK-MB-II, PATHFAST MYO-II
    K051650 STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.
    K041596 ARCHITECT STAT CK-MB IMMUNOASSAY
    K033747 RAMP CK-MB ASSAY
    K034055 IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
    K030012 CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372
    K022118 IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
    K013118 MODIFICATION TO ALPHA DX SYSTEM
    K004002 IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)
    K000716 ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER
    K994439 ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306
    K993068 VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS
    K991797 IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5
    K984067 STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK
    K981099 STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK
    K980012 CREATINE KINASE REAGENT
    K973126 TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I
    K972782 DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
    K962549 VIDAS CREATINE KINASE MB ASSAY 30-421
    K913380 MYDAS(TM)-MB2/MYDAS(TM)-MB
    K913298 AIA-PACK CK-MB
    K911121 CIBA CORNING ACS CKMB IMMUNOASSAY
    K903441 MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS
    K890543 IMPRES-MB REAGENT A AND REAGENT B
    K881267 BIOTROL CK MONOEACTIF
    K881237 CREATINE KINASE (CK) REAGENT SET
    K874144 TITAN GEL REP CPK-6 HV
    K873399 TITAN GEL CPK REP SYSTEM
    K873171 STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
    K870987 CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY
    K840549 CK-B RIA KIT
    K813573 CARDIOTRAC CORNING CK ISOENZYME SUBST
    K813087 ABURIA-CK RIA TEST KIT
    K812759 NML CK-MB RIA
    K802826 PARAGON ELECTRO. CREATINE KINASE TEST KI
    K801728 EMBRIA-CK
    K801318 HELENA ULTRA SENSITIVE CPK REAGENT/DILUE
    K800544 CORNING TRANSPHOR
    K792504 RIA-QUANT CK-MB TEST KIT
    K791582 CARDIO CK-B RIA KIT
    K790294 BUFFER, CORNING MOPSO
    K771605 CREATINE KINASE ISOENZYME SUBSTRATE SET
    K771324 3-(N-MORPHOLINS)-PROPANE SULFONIC ACID
    K760591 SIGMA PROCEDURE NO. 745 - EP.REAGENT SY

    FEI Numbers

    This FDA classification entry is associated with 31 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 31 registration numbers. Click on an entry to view related FDA registrations.