510(k) · Cleared
Clearedi-STAT hs-TnI cartridge with the i-STAT Alinity System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Point of Care, Inc. · MMI Immunoassay Method, Troponin Subunit
Cleared on Jun 11, 2026 as substantially equivalent to K240984 (Abbott Point of Care, Inc., 2025) after a 262-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Jun 11, 2026
- Review
- 262 days
- Class
- Class II
- Product code
- MMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K981098 (1998). No later device cites it as a predicate yet.
- Root · 6 generations backK981098 Stratus CS Cardiac Troponin I TestpakDade Behring, Inc. · 1998 · Recalled
- 5 generations backK984093 Stratus (R) CS Cardiac Troponin I (Trop) TestpakDade Behring, Inc. · 1998
- 4 generations backK033487 Stratus CS Acute Care Troponin I Testpak, Model CctniDade Behring, Inc. · 2003 · Recalled
- 3 generations backK100130 Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample…Mitsubishi Chemical Medience CO · 2011
- 2 generations backK231974 PATHFAST®hs-cTnI-IIPhc Corporation · 2024
- 1 generation backK240984 i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2025
- This deviceK253051 i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K981098 | Stratus CS Cardiac Troponin I Testpak | Dade Behring, Inc. | 1998 | 1 |
| −5 | K984093 | Stratus (R) CS Cardiac Troponin I (Trop) Testpak | Dade Behring, Inc. | 1998 | — |
| −4 | K033487 | Stratus CS Acute Care Troponin I Testpak, Model Cctni | Dade Behring, Inc. | 2003 | 1 |
| −3 | K100130 | Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2 | Mitsubishi Chemical Medience CO | 2011 | — |
| −2 | K231974 | PATHFAST®hs-cTnI-II | Phc Corporation | 2024 | — |
| −1 | K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2025 | — |
| 0 (this device) | K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity System | Abbott Point of Care, Inc. | 2026 | — |
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 K240984 i-STAT hs-TnI cartridge with the i-STAT 1 Systemscore 12.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 SystemSummary page 5…Chemistry 3. Predicate Device Proprietary Name: i-STAT hs-TnI Cartridge with the i-STAT 1 System 510(k) Number: K240984 510(k) Summary Page 1 of 24… | 2025 |
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 28 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 2 of the 6 ancestors have a recall of any class.
How does its category compare?
All MMI devicesMMI Immunoassay Method, Troponin Subunit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
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 hs-TnI cartridge with the i-STAT Alinity System is intended for use in the in vitro quantification of cardiac troponin I (cTnI) in whole blood or plasma samples in point of care or clinical laboratory settings.
The i-STAT hs-TnI cartridge with the i-STAT Alinity System is intended to be used as an aid in the diagnosis of myocardial infarction (MI).
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/K253051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253051: i-STAT hs-TnI cartridge with the i-STAT Alinity System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253051
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026