510(k) · Cleared
Recalled · Class II · 2019I-Stat Cardiac Troponin (Ctni) Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I-Stat Corporation · MMI Immunoassay Method, Troponin Subunit
Cleared on Sep 2, 2003 after a 90-day review. The FDA summary names its predicate without a number. It has been recalled 5 times.
- Decided
- Sep 2, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- MMI
- Recalls
- 5
- Predicates
- 0
The FDA summary names its predicate without a number.
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 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
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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 |
|---|---|---|---|
| * | — | Dade Behring Stratus CS Cardiac Troponin I TestPak Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 16, 2019 | Class II | Z-0761-2020 | Device Design | i-STAT cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range. |
| Nov 1, 2012 | Class II | Z-0716-2013 | Error in labeling | APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack. |
| Mar 7, 2012 | Class II | Z-2237-2012 | Device Design | Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. This recall was expanded on July 19 2012 to include additional information regarding user… |
| Feb 1, 2012 | Class II | Z-2169-2012 | Device Design | The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure. |
| Sep 29, 2011 | Not classified | Z-0180-2012 | Material/Component Contamination | i-Stat cTnI cartridges beginning with letter "T" may exhibit a higher than expected variability in reported results. This increased variability may result in falsely elevated or falsely depressed results. |
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?
The i-STAT Cardiac Troponin I (cTnl) test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031739: I-Stat Cardiac Troponin (Ctni) Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031739
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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