510(k) · Cleared
ClearedElecsys CK-MB Stat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · JHY Colorimetric Method, Cpk Or Isoenzymes
Cleared on Dec 17, 1997 as substantially equivalent to K961501 (Boehringer Mannheim Corp., 1996) after a 23-day review. Its family tree reaches back 2 generations to 1993. 3 later devices descend from it.
- Decided
- Dec 17, 1997
- Review
- 23 days
- Class
- Class II
- Product code
- JHY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K931172 (1993). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 1 generation backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- This deviceK974421 Elecsys CK-MB StatBoehringer Mannheim Corp. · 1997
- Descendant · cites it directly · 2 of its ownK022654 Modification to Elecsys CK-MB Stat, Elecsys CK-MBRoche Diagnostics Corp. · 2002
- Descendant · 2 generations on · 1 of its ownK132571 Elecsys CK-MB Stat Immunoassay, Elecsys CK-MB ImmunoassayRoche Diagnostics · 2013
- Descendant · 3 generations on · 0 of its ownK140404 Elecsys CK-MB Stat ImmunoassayRoche Diagnostics · 2014
Most influential descendants
Showing 3 of 3 · See all- K022654Modification to Elecsys CK-MB Stat, Elecsys CK-MBRoche Diagnostics Corp. · 2002 · cites it directly2descendants
- K132571Elecsys CK-MB Stat Immunoassay, Elecsys CK-MB ImmunoassayRoche Diagnostics · 2013 · 2 generations on1descendant
- K140404Elecsys CK-MB Stat ImmunoassayRoche Diagnostics · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −1 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| 0 (this device) | K974421 | Elecsys CK-MB Stat | Boehringer Mannheim Corp. | 1997 | — |
| +1 | K022654 | Modification to Elecsys CK-MB Stat, Elecsys CK-MB | Roche Diagnostics Corp. | 2002 | — |
| +2 | K132571 | Elecsys CK-MB Stat Immunoassay, Elecsys CK-MB Immunoassay | Roche Diagnostics | 2013 | — |
| +3 | K140404 | Elecsys CK-MB Stat Immunoassay | Roche Diagnostics | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K961501 | Elecsys CK-MBSummary page 1…al distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed first generation Boehringer Mannheim Elecsys CK-MB STAT (K961501). Continued on next page UAQA_QQCWQA\RA\Elecsys\S 10(k)'s\CK-MB\CK-MB 510k FDA.doc 25 Boehringer Mannheim Corpo… | 1996 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022654 | Modification to Elecsys CK-MB Stat, Elecsys CK-MB | 2002 | 2 |
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 4 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K022654 (Roche Diagnostics Corp., 2002) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K961501.
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 (CK-MB) in human serum and plasma.
A creatine phosphokinase / creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine kinase 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974421: Elecsys CK-MB Stat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974421
Report an extraction error
Are you the manufacturer?
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