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.
Recent Cleared Devices (20 of 48)
Showing 20 most recent of 48 cleared devices.
| 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 |
Top Applicants
- Intl. Immunoassay Laboratories, Inc. — 5 clearances
- Beckman Coulter, Inc. — 4 clearances
- Corning Medical & Scientific — 4 clearances
- Diagnostic Products Corp. — 4 clearances
- Dade Behring, Inc. — 3 clearances
