JHX · Fluorometric Method, Cpk Or Isoenzymes
Clinical Chemistry · 21 CFR 862.1215 · Class 2
Overview
| Product Code | JHX |
|---|---|
| Device Name | Fluorometric Method, Cpk Or Isoenzymes |
| Regulation | 21 CFR 862.1215 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Classification Rationale
Class II.
Cleared Devices (48)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K234005 | Access CK-MB | Beckman Coulter, Inc. | Feb 16, 2024 | SESE |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent Pack | Ortho Clinical Diagnostics | Jan 28, 2022 | SESE |
| K163462 | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX | Radiometer Medical Aps | Sep 21, 2017 | SESE |
| K120326 | AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE | Radiometer Medical Aps | Nov 21, 2012 | SESE |
| K081360 | PATHFAST CK-MB-II, PATHFAST MYO-II | Mitsubishi Kagaku Iatron | Aug 17, 2009 | SESE |
| K051650 | STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. | Dade Behring, Inc. | Sep 8, 2005 | SESE |
| K041596 | ARCHITECT STAT CK-MB IMMUNOASSAY | Fisher Diagnostics | Jul 21, 2004 | SESE |
| K033747 | RAMP CK-MB ASSAY | Response Biomedical Corp. | May 17, 2004 | SESE |
| K034055 | IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I | Diagnostic Products Corp. | Jan 21, 2004 | SESE |
| K030012 | CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 | Beckman Coulter, Inc. | Jan 17, 2003 | SESE |
| K022118 | IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) | Diagnostic Products Corp. | Jul 22, 2002 | SESE |
| K013118 | MODIFICATION TO ALPHA DX SYSTEM | First Medical, Inc. | Oct 15, 2001 | SESE |
| K004002 | IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) | Diagnostic Products Corp. | Feb 14, 2001 | SESE |
| K000716 | ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER | Beckman Coulter, Inc. | Mar 20, 2000 | SESE |
| K994439 | ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306 | Beckman Coulter, Inc. | Jan 14, 2000 | SESE |
| K993068 | VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS | Ortho-Clinical Diagnostics | Oct 4, 1999 | SESE |
| K991797 | IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 | Diagnostic Products Corp. | Jun 9, 1999 | SESE |
| K984067 | STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK | Dade Behring, Inc. | Jan 13, 1999 | SESE |
| K981099 | STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK | Dade Behring, Inc. | May 26, 1998 | SESE |
| K980012 | CREATINE KINASE REAGENT | Ac Biochemicals, Inc. | Feb 25, 1998 | SESE |
| K973126 | TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I | Biosite Incorporated | Oct 6, 1997 | SESE |
| K972782 | DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | Dade Intl., Inc. | Aug 15, 1997 | SESE |
| K962549 | VIDAS CREATINE KINASE MB ASSAY 30-421 | Biomerieux Vitek, Inc. | Aug 30, 1996 | SESE |
| K913380 | MYDAS(TM)-MB2/MYDAS(TM)-MB | Intl. Immunoassay Laboratories, Inc. | Apr 22, 1992 | SESE |
| K913298 | AIA-PACK CK-MB | Tosoh Corp. | Sep 27, 1991 | SESE |
| K911121 | CIBA CORNING ACS CKMB IMMUNOASSAY | Ciba Corning Diagnostics Corp. | Apr 3, 1991 | SESE |
| K903441 | MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS | Intl. Immunoassay Laboratories, Inc. | Nov 6, 1990 | SESE |
| K890543 | IMPRES-MB REAGENT A AND REAGENT B | Intl. Immunoassay Laboratories, Inc. | Mar 13, 1989 | SESE |
| K881267 | BIOTROL CK MONOEACTIF | Biotrol, USA, Inc. | May 16, 1988 | SESE |
| K881237 | CREATINE KINASE (CK) REAGENT SET | Tech-Neal Scientific, Inc. | Apr 28, 1988 | SESE |
| K874144 | TITAN GEL REP CPK-6 HV | Helena Laboratories | Nov 23, 1987 | SESE |
| K873399 | TITAN GEL CPK REP SYSTEM | Helena Laboratories | Oct 20, 1987 | SESE |
| K873171 | STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | American Dade | Sep 29, 1987 | SESE |
| K870987 | CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY | Ciba Corning Diagnostics Corp. | May 26, 1987 | SESE |
| K840549 | CK-B RIA KIT | Diagnostic Systems Laboratories, Inc. | May 7, 1984 | SESE |
| K813573 | CARDIOTRAC CORNING CK ISOENZYME SUBST | Corning Medical & Scientific | Jan 18, 1982 | SESE |
| K813087 | ABURIA-CK RIA TEST KIT | Intl. Immunoassay Laboratories, Inc. | Dec 17, 1981 | SESE |
| K812759 | NML CK-MB RIA | Nuclear Medical Laboratories, Inc. | Oct 19, 1981 | SESE |
| K802826 | PARAGON ELECTRO. CREATINE KINASE TEST KI | Beckman Instruments, Inc. | Jan 9, 1981 | SESE |
| K801728 | EMBRIA-CK | Intl. Immunoassay Laboratories, Inc. | Sep 26, 1980 | SESE |
| K801318 | HELENA ULTRA SENSITIVE CPK REAGENT/DILUE | Helena Laboratories | Jul 14, 1980 | SESE |
| K800544 | CORNING TRANSPHOR | Corning Medical & Scientific | Mar 20, 1980 | SESE |
| K792504 | RIA-QUANT CK-MB TEST KIT | Mallinckrodt Critical Care | Jan 16, 1980 | SESE |
| K791582 | CARDIO CK-B RIA KIT | Nuclear Medical Systems, Inc. | Nov 15, 1979 | SESE |
| K790294 | BUFFER, CORNING MOPSO | Corning Medical & Scientific | Mar 21, 1979 | SESE |
| K771605 | CREATINE KINASE ISOENZYME SUBSTRATE SET | Pfizer Pharmaceuticals | Sep 15, 1977 | SESE |
| K771324 | 3-(N-MORPHOLINS)-PROPANE SULFONIC ACID | Corning Medical & Scientific | Sep 2, 1977 | SESE |
| K760591 | SIGMA PROCEDURE NO. 745 - EP.REAGENT SY | Sigma Chemical Co. | Oct 29, 1976 | SESE |
Top Applicants
- Intl. Immunoassay Laboratories, Inc. — 5 clearances
- Diagnostic Products Corp. — 4 clearances
- Corning Medical & Scientific — 4 clearances
- Beckman Coulter, Inc. — 4 clearances
- Helena Laboratories — 3 clearances
