510(k) · Cleared
ClearedCarestart Cardiac 3-in-1 Troponin 1/CK-MB/Myoglobin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Access Bio Incorporate · MMI Immunoassay Method, Troponin Subunit
Cleared on Nov 29, 2005 after a 134-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 29, 2005
- Review
- 134 days
- Class
- Class II
- Product code
- MMI
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MMI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MMI device
- #1 K253051 i-STAT hs-TnI cartridge with the i-STAT…score 13.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All MMI devicesMMI Immunoassay Method, Troponin Subunit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MMI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MMI
266in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MMI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MMI
805in 2025
MAUDE reports naming product code MMI, 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 | 3 | 190 | 6 | 352 |
| 2008 | 1 | — | 2 | 837 |
| 2009 | 1 | — | 3 | 1,010 |
| 2010 | 2 | — | 5 | 1,335 |
| 2011 | 1 | — | 1 | 2,406 |
| 2012 | 0 | — | 6 | 1,841 |
| 2013 | 2 | — | 0 | 1,394 |
| 2014 | 0 | — | 1 | 1,150 |
| 2015 | 0 | — | 1 | 831 |
| 2016 | 0 | — | 0 | 487 |
| 2017 | 1 | — | 0 | 618 |
| 2018 | 4 | 344 | 0 | 487 |
| 2019 | 3 | 88 | 1 | 521 |
| 2020 | 0 | — | 1 | 387 |
| 2021 | 1 | — | 1 | 356 |
| 2022 | 1 | — | 0 | 507 |
| 2023 | 3 | 270 | 0 | 748 |
| 2024 | 2 | — | 1 | 921 |
| 2025 | 4 | 266 | 0 | 805 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
CareStart Tm Cardiac 3-in-1 Troponin I/CK-MB/Myoglobin Test is intended for the qualitative detection of cardiac troponin I, CK-MB and myoglobin in human blood, serum or plasma. Measurement of cardiac troponin I, CK-MB and myoglobin aids in rapid diagnosis of acute myocardial infarction. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting. CareStart Tm Cardiac 2-in-1 Troponin I/Myoglobin Test is intended…
Read the full statement (205 words)
CareStart Tm Cardiac 3-in-1 Troponin I/CK-MB/Myoglobin Test is intended for the qualitative detection of cardiac troponin I, CK-MB and myoglobin in human blood, serum or plasma. Measurement of cardiac troponin I, CK-MB and myoglobin aids in rapid diagnosis of acute myocardial infarction. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting.
CareStart Tm Cardiac 2-in-1 Troponin I/Myoglobin Test is intended for the qualitative detection of cardiac troponin I, and myoglobin in human blood, serum or plasma. Measurement of cardiac troponin I, and myoglobin aids in rapid diagnosis of acute myocardial infarction. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting.
CareStartTM Cardiac CKMB Test is intended for the qualitative detection of CK-MB in human blood, serum or plasma. Measurement of CK-MB aids in rapid diagnosis of acute myocardial infarction. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting.
CareStartrm Cardiac Troponin I Test is intended for the qualitative detection of cardiac troponin I in human blood, serum or plasma. Measurement of cardiac troponin I aids in rapid diagnosis of acute myocardial infarction. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051925 · printed Nov 3, 2026
Cite this page
510(k) Report. “K051925: Carestart Cardiac 3-in-1 Troponin 1/CK-MB/Myoglobin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K051925
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026