510(k) · Cleared
ClearedElecsys CK-MB Stat Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · JHY Colorimetric Method, Cpk Or Isoenzymes
Cleared on May 8, 2014 as substantially equivalent to K132571 (Roche Diagnostics, 2013) after a 79-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- May 8, 2014
- Review
- 79 days
- Class
- Class II
- Product code
- JHY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K931172 (1993). No later device cites it as a predicate yet.
- Root · 5 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 4 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 3 generations backK974421 Elecsys CK-MB StatBoehringer Mannheim Corp. · 1997
- 2 generations backK022654 Modification to Elecsys CK-MB Stat, Elecsys CK-MBRoche Diagnostics Corp. · 2002
- 1 generation backK132571 Elecsys CK-MB Stat Immunoassay, Elecsys CK-MB ImmunoassayRoche Diagnostics · 2013
- This deviceK140404 Elecsys CK-MB Stat ImmunoassayRoche Diagnostics · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −4 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −3 | K974421 | Elecsys CK-MB Stat | Boehringer Mannheim Corp. | 1997 | — |
| −2 | 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 | — |
| 0 (this device) | K140404 | Elecsys CK-MB Stat Immunoassay | Roche Diagnostics | 2014 | — |
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 |
|---|---|---|---|
| * | K132571 | Elecsys CK-MB Stat Immunoassay, Elecsys CK-MB ImmunoassaySummary page 1…Product Code: JHY Predicate Device: CK-MEB STAT Immunoassay, Roche Diagnostics (K132571) Continued on next page Roche Diagnostics… | 2013 |
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?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 5 ancestors has a recall.
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. 2014, this device’s year, is highlighted.
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 the MB isoenzyme of creatine kinase are used as an aid in the diagnosis of myocardial infarction.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
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/K140404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140404: Elecsys CK-MB Stat Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140404
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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