Creatine Kinase-MB
FDA 510(k) K162526 · Roche Diagnostics
510(k) numberK162526
Submission
- Device name
- Creatine Kinase-MB
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- September 9, 2016
- Decision date
- May 26, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JHW – U.V. Method, Cpk Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K141265 | Elitech Clinical Systems Envoy 500 CK Reagent KitJHW · Traditional | Elitechgroup | 07/18/2014SE |
| K122083 | Elitech Clinical Systems CK Nac SLJHW · Traditional | Elitechgroup | 08/22/2012SE |
| K023744 | Wiener Lab. Ck-Mb DS UV Unitest, Model 28 X 2.5 ML Cat. Nr. 1271354JHW · Traditional | Wiener Laboratories Saic | 01/03/2003SE |
| K003158 | Roche Diagnostics Ck-MbJHW · Traditional | Roche Diagnostics Corp. | 12/18/2000SE |
| K961501 | Elecsys Ck-MbJHW · Traditional | Boehringer Mannheim Corp. | 06/11/1996SE |
| K950186 | Ck-Mb Method for the Technicon Immuno 1(R) System In-Vitro Diagnostic SystemJHW · Traditional | Miles, Inc. | 03/13/1995SE |
| K944325 | Lifesign, Care Point, Vitalsign, AccusignJHW · Traditional | Princeton BioMeditech Corp. | 02/22/1995SE |
| K942958 | Creatine Kinase MB Determination (UV)JHW · Traditional | Biochemical Trade, Inc. | 11/21/1994SE |
| K935924 | Axsym Ck-MbJHW · Traditional | Abbott Laboratories | 06/21/1994SE |
| K931050 | Cardio Rep CK Isoenzyme Kit - 3310JHW · Traditional | Helena Laboratories | 04/20/1993SE |
More from Helena Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) PlasmaSET · Traditional | 08/19/2026SE |
| K252323 | cobas pulse blood glucose monitoring systemPZI · Dual Track | 06/12/2026SE |
| K252431 | Elecsys CalcitoninJKR · Traditional | 04/24/2026SE |
| K252280 | Elecsys Anti-SARS-CoV-2 SQVP · Traditional | 04/13/2026SE |
| K260049 | Elecsys Anti-HBc IgMSEI · Traditional | 04/07/2026SE |
| K260048 | Elecsys Anti-HAV IgMLOL · Traditional | 04/07/2026SE |
| K260046 | Elecsys Anti-HBc IISEI · Traditional | 04/07/2026SE |
| K260026 | Tina-quant Cardiac high sensitivity CRP IIINQD · Traditional | 04/02/2026SE |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | 02/12/2026SE |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | 02/12/2026SE |
Questions and answers
When was Creatine Kinase-MB cleared by the FDA?
Creatine Kinase-MB (K162526) received a 510(k) decision of Substantially Equivalent on May 26, 2017, 259 days after the submission was received.
What is the product code of K162526?
The FDA product code is JHW – U.V. Method, Cpk Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.