Fluorometric Method, Cpk Or Isoenzymes
FDA product code JHX · Class II (moderate risk) · 21 CFR 862.1215 · Clinical Chemistry
48510(k) clearances
0PMA approvals
12recalls
Manufacturers
- Intl. Immunoassay Laboratories, Inc. 5
- Corning Medical & Scientific 4
- Diagnostic Products Corp. 4
- Beckman Coulter Inc. 4
- Helena Laboratories 3
- Dade Behring, Inc. 3
- Ortho-Clinical Diagnostics 2
- Ciba Corning Diagnostics Corp. 2
- Radiometer Medical Aps 2
- Sigma Chemical Co. 1
- Mallinckrodt Critical Care 1
- Pfizer Pharmaceuticals 1
- Biomerieux Vitek, Inc. 1
- Tosoh Corp. 1
- Biotrol, USA, Inc. 1
- Tech-Neal Scientific, Inc. 1
- American Dade 1
- Diagnostic Systems Laboratories, Inc. 1
- Nuclear Medical Laboratories, Inc. 1
- Beckman Instruments, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K234005 | Access CK-MBJHX · Traditional | Beckman Coulter, Inc. | 02/16/2024SE |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent PackJHX · Traditional | Ortho Clinical Diagnostics | 01/28/2022SE |
| K163462 | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXJHX · Traditional | Radiometer Medical Aps | 09/21/2017SE |
| K120326 | AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal…JHX · Traditional | Radiometer Medical Aps | 11/21/2012SE |
| K081360 | Pathfast Ck-Mb-Ii, Pathfast Myo-IiJHX · Traditional | Mitsubishi Kagaku Iatron | 08/17/2009SE |
| K051650 | Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute…JHX · Traditional | Dade Behring, Inc. | 09/08/2005SE |
| K041596 | Architect Stat Ck-Mb ImmunoassayJHX · Traditional | Fisher Diagnostics | 07/21/2004SE |
| K033747 | Ramp Ck-Mb AssayJHX · Traditional | Response Biomedical Corp. | 05/17/2004SE |
| K034055 | Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special | Diagnostic Products Corp. | 01/21/2004SE |
| K030012 | Ck-Mb and Ck-Mb Calibrators on the Access Immunoassay Systems, Models 386371 and 386372JHX · Special | Beckman Coulter, Inc. | 01/17/2003SE |
| K022118 | Immulite Turbo Ck-Mb, Models LSKCP1 (100 Tests), LSKCP5 (500 Tests)JHX · Special | Diagnostic Products Corp. | 07/22/2002SE |
| K013118 | Modification to Alpha DX SystemJHX · Special | First Medical, Inc. | 10/15/2001SE |
| K004002 | Immulite Ck-Mb, Model LKMB1 (100 Tests), LKMB5 (500 Tests); Immulite 2000 Ck-Mb, Model…JHX · Traditional | Diagnostic Products Corp. | 02/14/2001SE |
| K000716 | Access Ck-Mb on the Access Immunoassay AnalyzerJHX · Special | Beckman Coulter, Inc. | 03/20/2000SE |
| K994439 | Access Ck-Mb on the Access Immunoassay Analyzer, Models 33300, 33305, 33309, 33306JHX · Traditional | Beckman Coulter, Inc. | 01/14/2000SE |
| K993068 | Vitros Immunodiagnostic Products Ck-Mb Reagent Pack ; Vitros Immunodiagnostic Products…JHX · Special | Ortho-Clinical Diagnostics | 10/04/1999SE |
| K991797 | Immulite Turbo Ck-Mb, Models LSKCP1, LSKCP5JHX · Special | Diagnostic Products Corp. | 06/09/1999SE |
| K984067 | Stratus (R) CS Stat Fluorometric Analyzer, Stratus (R) CS CKMB Test PakJHX · Traditional | Dade Behring, Inc. | 01/13/1999SE |
| K981099 | Stratus CS Stat Fluorometric Analyzer and Stratus CS CKMB TestpakJHX · Traditional | Dade Behring, Inc. | 05/26/1998SE |
| K980012 | Creatine Kinase ReagentJHX · Traditional | Ac Biochemicals, Inc. | 02/25/1998SE |
| K973126 | Triage Cardiac Panel, Triage Troponin-I, Triage Ck-Mb, Triage Myoglobin, Triage…JHX · Traditional | Biosite Incorporated | 10/06/1997SE |
| K972782 | Dade Stratus Ck-Mb Fluorometric Enzyme ImmunoassayJHX · Traditional | Dade Intl., Inc. | 08/15/1997SE |
| K962549 | Vidas Creatine Kinase MB Assay 30-421JHX · Traditional | Biomerieux Vitek, Inc. | 08/30/1996SE |
| K913380 | MYDAS(TM)-MB2/MYDAS(TM)-MBJHX · Traditional | Intl. Immunoassay Laboratories, Inc. | 04/22/1992SE |
| K913298 | Aia-Pack Ck-MbJHX · Traditional | Tosoh Corp. | 09/27/1991SE |
| K911121 | Ciba Corning Acs CKMB ImmunoassayJHX · Traditional | Ciba Corning Diagnostics Corp. | 04/03/1991SE |
| K903441 | Mydas(Tm) Brand Solid-Phase Antibody ReagentsJHX · Traditional | Intl. Immunoassay Laboratories, Inc. | 11/06/1990SE |
| K890543 | Impres-Mb Reagent a and Reagent BJHX · Traditional | Intl. Immunoassay Laboratories, Inc. | 03/13/1989SE |
| K881267 | Biotrol CK MonoeactifJHX · Traditional | Biotrol, USA, Inc. | 05/16/1988SE |
| K881237 | Creatine Kinase (CK) Reagent SetJHX · Traditional | Tech-Neal Scientific, Inc. | 04/28/1988SE |
| K874144 | Titan Gel Rep CPK-6 HVJHX · Traditional | Helena Laboratories | 11/23/1987SE |
| K873399 | Titan Gel CPK Rep SystemJHX · Traditional | Helena Laboratories | 10/20/1987SE |
| K873171 | Stratus(R) Ck-Mb Fluorometric Enzyme ImmunoassayJHX · Traditional | American Dade | 09/29/1987SE |
| K870987 | Ciba Corning Magic(R) Lite CKMB ImmunoassayJHX · Traditional | Ciba Corning Diagnostics Corp. | 05/26/1987SE |
| K840549 | Ck-B Ria KitJHX · Traditional | Diagnostic Systems Laboratories, Inc. | 05/07/1984SE |
| K813573 | Cardiotrac Corning CK Isoenzyme SubstJHX · Traditional | Corning Medical & Scientific | 01/18/1982SE |
| K813087 | Aburia-Ck Ria Test KitJHX · Traditional | Intl. Immunoassay Laboratories, Inc. | 12/17/1981SE |
| K812759 | NML Ck-Mb RiaJHX · Traditional | Nuclear Medical Laboratories, Inc. | 10/19/1981SE |
| K802826 | Paragon Electro. Creatine Kinase Test KiJHX · Traditional | Beckman Instruments, Inc. | 01/09/1981SE |
| K801728 | Embria-CkJHX · Traditional | Intl. Immunoassay Laboratories, Inc. | 09/26/1980SE |
| K801318 | Helena Ultra Sensitive CPK Reagent/DilueJHX · Traditional | Helena Laboratories | 07/14/1980SE |
| K800544 | Corning TransphorJHX · Traditional | Corning Medical & Scientific | 03/20/1980SE |
| K792504 | Ria-Quant Ck-Mb Test KitJHX · Traditional | Mallinckrodt Critical Care | 01/16/1980SE |
| K791582 | Cardio Ck-B Ria KitJHX · Traditional | Nuclear Medical Systems, Inc. | 11/15/1979SE |
| K790294 | Buffer, Corning MopsoJHX · Traditional | Corning Medical & Scientific | 03/21/1979SE |
| K771605 | Creatine Kinase Isoenzyme Substrate SetJHX · Traditional | Pfizer Pharmaceuticals | 09/15/1977SE |
| K771324 | 3-(N-MORPHOLINS)-PROPANE Sulfonic AcidJHX · Traditional | Corning Medical & Scientific | 09/02/1977SE |
| K760591 | Sigma Procedure No. 745 - Ep.Reagent SyJHX · Traditional | Sigma Chemical Co. | 10/29/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1673-2025 Class II | Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for… | Siemens Healthcare Diagnostics Inc | 03/31/2025Open, Classified |
| Z-3185-2018 Class II | PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST NTproBNP is a…A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage… | Polymedco, Inc.,/Polymedco Cancer… | 04/30/2018Terminated |
| Z-2071-2018 Class II | ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac MarkerAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-2525-2016 Class II | Stratus CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures…Software defect, where either an Above Assay Range or an inaccurate value could potentially be reported, in… | Siemens Healthcare Diagnostics Inc | 06/22/2016Terminated |
| Z-0619-2016 Class II | Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in…Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Siemens Healthcare Diagnostics Inc | 11/11/2015Terminated |
| Z-0613-2016 Class II | Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB…Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Siemens Healthcare Diagnostics Inc | 11/11/2015Terminated |
| Z-1274-2012 | IMMULITE 2500 CK-MB L5KCP --- Catalog number: L5KCP2 (200 tests), L5KCP6 (600 tests) ---…Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of… | Siemens Healthcare Diagnostics | 01/25/2012Terminated |
| Z-1273-2012 | IMMULITE 2000/IMMULITE 2000 XPi CK-MB L2KMB --- Catalog number: L2KMB2 (200 tests)…Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of… | Siemens Healthcare Diagnostics | 01/25/2012Terminated |
| Z-1272-2012 | IMMULITE/IMMULITE Turbo 1000 CK-MB LSKCP --- Catalog number: LSKCP1 (100 tests), LSKCP5…Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of… | Siemens Healthcare Diagnostics | 01/25/2012Terminated |
| Z-1271-2012 | IMMULITE/IMMULITE 1000 CK-MB LKMB --- Catalog number: LKMB1 (100 tests), LKMB5 (500…Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of… | Siemens Healthcare Diagnostics | 01/25/2012Terminated |
| Z-0343-2011 | Stratus(R) CS Rotors, catalog number CROTOR, lot number NH42-251-09 Intended use:…Low frequency defect in the gel filling of this lot that may result in inadequate separation of cells in… | Siemens Healthcare Diagnostics, Inc. | 12/07/2009Terminated |
| Z-0668-2009 | Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.Incorrect result: Potential for false elevation of CTnI results | Dade Behring, Inc. | 06/23/2008Terminated |