510(k) · Cleared
ClearedCreatine Kinase-MB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · JHW U.V. Method, Cpk Isoenzymes
Cleared on May 26, 2017 as substantially equivalent to K003158 (Roche Diagnostics Corp., 2000) after a 259-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- May 26, 2017
- Review
- 259 days
- Class
- Class II
- Product code
- JHW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003158 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK003158 Roche Diagnostics CK-MBRoche Diagnostics Corp. · 2000
- This deviceK162526 Creatine Kinase-MBRoche Diagnostics · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003158 | Roche Diagnostics CK-MB | Roche Diagnostics Corp. | 2000 | — |
| 0 (this device) | K162526 | Creatine Kinase-MB | Roche Diagnostics | 2017 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JHW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003158 | Roche Diagnostics CK-MBSummary page 5…enzymes test system. Classification Name Product Codes, JHW, 21 CFR § 862.1215 Regulation Numbers Predicate Devices Roche CK-MB, k003158 For the Creatine Kinase-MB assay, the establishment registration number for… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K003158.
How does its category compare?
All JHW devicesJHW U.V. Method, Cpk Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · JHW
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JHW
Too few JHW 510(k)s in any year since 2007 to give a median.
Recalls per year · JHW
No recall names JHW since 2007.
Adverse event reports per year · JHW
1in 2024
MAUDE reports naming product code JHW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Creatine Kinase-MB assay is an in-vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162526: Creatine Kinase-MB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162526
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026