510(k) · Cleared
ClearedModification to Elecsys CK-MB Stat, Elecsys CK-MB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JHY Colorimetric Method, Cpk Or Isoenzymes
Cleared on Aug 29, 2002 as substantially equivalent to K974421 (Boehringer Mannheim Corp., 1997) after a 20-day review. Its family tree reaches back 3 generations to 1993. 2 later devices descend from it.
- Decided
- Aug 29, 2002
- Review
- 20 days
- Class
- Class II
- Product code
- JHY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K931172 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 2 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 1 generation backK974421 Elecsys CK-MB StatBoehringer Mannheim Corp. · 1997
- This deviceK022654 Modification to Elecsys CK-MB Stat, Elecsys CK-MBRoche Diagnostics Corp. · 2002
- Descendant · cites it directly · 1 of its ownK132571 Elecsys CK-MB Stat Immunoassay, Elecsys CK-MB ImmunoassayRoche Diagnostics · 2013
- Descendant · 2 generations on · 0 of its ownK140404 Elecsys CK-MB Stat ImmunoassayRoche Diagnostics · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −2 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −1 | K974421 | Elecsys CK-MB Stat | Boehringer Mannheim Corp. | 1997 | — |
| 0 (this device) | K022654 | Modification to Elecsys CK-MB Stat, Elecsys CK-MB | Roche Diagnostics Corp. | 2002 | — |
| +1 | K132571 | Elecsys CK-MB Stat Immunoassay, Elecsys CK-MB Immunoassay | Roche Diagnostics | 2013 | — |
| +2 | K140404 | Elecsys CK-MB Stat Immunoassay | Roche Diagnostics | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
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 JHY? 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 |
|---|---|---|---|
| * | K974421 | Elecsys CK-MB StatSummary page 2…SB CK-MB STAT and ELECSYSB C K-MB, continued Predicate We claim substantial equivalence to the currently marketed ElecsysB CK-MB Device STAT Assay. (K974421). Reagent The following table describes the similarities and differences between the Summary original Elecs… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132571 | Elecsys CK-MB Stat Immunoassay, Elecsys CK-MB Immunoassay | 2013 | 1 |
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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K132571 (Roche Diagnostics, 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JHY devicesJHY Colorimetric Method, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHY
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · JHY
Too few JHY 510(k)s in any year since 2007 to give a median.
Recalls per year · JHY
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHY
3in 2023
MAUDE reports naming product code JHY, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. 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. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Roche Elecsys 1010 / 2010 and Modular Analytics E170 (Elecsys…
Read the full statement (136 words)
Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. 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.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Roche Elecsys 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.
Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. 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.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Roche Elecsys 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022654: Modification to Elecsys CK-MB Stat, Elecsys CK-MB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022654
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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