Colorimetric Method, Cpk Or Isoenzymes
FDA product code JHY · Class II (moderate risk) · 21 CFR 862.1215 · Clinical Chemistry
40510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Hybritech, Inc. 5
- Roche Diagnostics Corp. 3
- Roche Diagnostic Systems, Inc. 2
- Abbott Laboratories 2
- Intl. Immunoassay Laboratories, Inc. 2
- Amresco, Inc. 1
- Siemens Healthcare Diagnostics, Inc. 1
- V-Tech, Inc. 1
- Bd Becton Dickinson Vacutainer Systems Preanalytic 1
- Eastman Kodak Company 1
- Tech-Co, Inc. 1
- Catachem, Inc. 1
- Sherwood Medical Industries 1
- American Research Products Co. 1
- Wako Chemicals USA, Inc. 1
- Sterling Biochemical, Inc. 1
- Calbiochem-Behring Corp. 1
- Diagnostic Solutions, Inc. 1
- Electrophoresis Corp. of America 1
- Electrophoresis Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143720 | Dimension Vista MMB AssayJHY · Traditional | Siemens Healthcare Diagnostics | 09/18/2015SE |
| K130080 | Easyra Ck-Mb Reagent, Easyra CRP Reagent, Easy Cal CRP Calibrator Kit, Easyqc CRP…JHY · Traditional | Medica Corporation | 05/13/2014SE |
| K140404 | Elecsys Ck-Mb Stat ImmunoassayJHY · Special | Roche Diagnostics | 05/08/2014SE |
| K132571 | Elecsys Ck-Mb Stat Immunoassay, Elecsys Ck-Mb ImmunoassayJHY · Traditional | Roche Diagnostics | 10/18/2013SE |
| K070835 | Olympus Ck-Mb ReagentJHY · Traditional | Olympus Life & Material Science Europa GmbH (Irish | 06/04/2007SE |
| K022757 | Spife CK Kit, Model 3332, 3333JHY · Traditional | Helena Laboratories | 10/11/2002SE |
| K022654 | Modification to Elecsys Ck-Mb Stat, Elecsys Ck-MbJHY · Special | Roche Diagnostics Corp. | 08/29/2002SE |
| K974421 | Elecsys Ck-Mb StatJHY · Traditional | Boehringer Mannheim Corp. | 12/17/1997SE |
| K970343 | MMB MethodJHY · Traditional | Dade Chemistry Systems, Inc. | 02/14/1997SE |
| K961412 | Ck-Mb Method for the Technicon Immuno 1 System In-VitroJHY · Traditional | Bayer Corp. | 06/18/1996SE |
| K951638 | Auraflex Ck-Mb 200TEST Pack, Calibrator PackJHY · Traditional | Organon Teknika Corp. | 05/02/1995SE |
| K931172 | Imx(R) Stat Ck-MbJHY · Traditional | Abbott Laboratories | 06/15/1993SE |
| K924429 | Opus(R) Ck-MbJHY · Traditional | Pb Diagnostic Systems, Inc. | 10/15/1992SE |
| K922700 | Du Pont Aca Plus Immunoassay System MB Mckmb Meth.JHY · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 08/20/1992SE |
| K921763 | Tandem Icon QSR CKMB Immunoenzymetric AssayJHY · Traditional | Hybritech, Inc. | 06/09/1992SE |
| K912766 | Amerlite Ck-Mb AssayJHY · Traditional | Amersham Corp. | 07/17/1991SE |
| K896240 | Cobas Ready CK ReagentJHY · Traditional | Roche Diagnostic Systems, Inc. | 02/16/1990SE |
| K895870 | Isoscreen-Ck Confirmatory KitJHY · Traditional | Roche Diagnostic Systems, Inc. | 12/01/1989SE |
| K890295 | Target(Tm) Ck-MbJHY · Traditional | V-Tech, Inc. | 08/15/1989SE |
| K884550 | Creatine Kinase MB Enzyme Immunoassay KitJHY · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/23/1989SE |
| K884085 | Tandem Icon QSR CKMB Immunoenzymetric AssayJHY · Traditional | Hybritech, Inc. | 12/02/1988SE |
| K883013 | Imx CKMBJHY · Traditional | Abbott Laboratories | 08/08/1988SE |
| K881351 | Imack-Mb, Catalogs 602-1, 602-1/125, 602-1/225JHY · Traditional | Intl. Immunoassay Laboratories, Inc. | 06/01/1988SE |
| K875192 | Kodak Ektachem DT Slides (CKMB)JHY · Traditional | Eastman Kodak Company | 02/24/1988SE |
| K880178 | Creatine Kinase (Colorimetric Method)JHY · Traditional | Tech-Co, Inc. | 02/18/1988SE |
| K874545 | Imack-Mb Test Procedure (Modification)JHY · Traditional | Intl. Immunoassay Laboratories, Inc. | 12/18/1987SE |
| K872063 | Tandem-E Immunoenzymetric Assay for CKMB IIJHY · Traditional | Hybritech, Inc. | 06/19/1987SE |
| K871677 | Creatine Kinase for Continuous Flow InstrumentsJHY · Traditional | Catachem, Inc. | 05/12/1987SE |
| K860663 | Amresco Flow Pac Creatine Phosphokinase ReagentJHY · Traditional | Amresco, Inc. | 04/11/1986SE |
| K845024 | Baker CKMB Reagent SetJHY · Traditional | Hybritech, Inc. | 01/18/1985SE |
| K832977 | Flow-Pac CPK Reagent SetJHY · Traditional | American Research Products Co. | 04/05/1984SE |
| K832139 | Tandem - E-Ckmb Immunoenzymetric AssayJHY · Traditional | Hybritech, Inc. | 08/12/1983SE |
| K832004 | Wako CPK TestJHY · Traditional | Wako Chemicals USA, Inc. | 08/11/1983SE |
| K830672 | Creatine Kinase Reagent SetJHY · Traditional | Sterling Biochemical, Inc. | 04/05/1983SE |
| K820812 | Creatine Kinase-Mb KitJHY · Traditional | Calbiochem-Behring Corp. | 04/12/1982SE |
| K800684 | Reagent for Determ. Creatine PhosphokinaJHY · Traditional | Diagnostic Solutions, Inc. | 05/28/1980SE |
| K791655 | CPK Isoenzyme ReagentJHY · Traditional | Electrophoresis Corp. of America | 09/17/1979SE |
| K790309 | CPK Isoenzyme SubstrateJHY · Traditional | Electrophoresis Corp. | 04/04/1979SE |
| K761212 | CPK1SOENZYMES Determination Pro. #715-EPJHY · Traditional | Sigma Chemical Co. | 12/21/1976SE |
| K760871 | Lancer Mb/Cpk Isoenzyme KitJHY · Traditional | Sherwood Medical Industries | 11/02/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1672-2018 Class II | Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridgeConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | Siemens Healthcare Diagnostics, Inc. | 01/02/2018Terminated |
| Z-1641-2011 | CK-MB ELISA kit ; BioCheck, Foster City, CA 9440. Quantitative determination of AFP…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | BioCheck Inc | 12/22/2010Terminated |