510(k) · Cleared
ClearedPATHFAST®hs-cTnI-II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phc Corporation · MMI Immunoassay Method, Troponin Subunit
Cleared on Mar 20, 2024 as substantially equivalent to K100130 (Mitsubishi Chemical Medience CO, 2011) after a 261-day review. Its family tree reaches back 4 generations to 1998. 2 later devices descend from it.
- Decided
- Mar 20, 2024
- Review
- 261 days
- Class
- Class II
- Product code
- MMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K981098 (1998). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK981098 Stratus CS Cardiac Troponin I TestpakDade Behring, Inc. · 1998 · Recalled
- 3 generations backK984093 Stratus (R) CS Cardiac Troponin I (Trop) TestpakDade Behring, Inc. · 1998
- 2 generations backK033487 Stratus CS Acute Care Troponin I Testpak, Model CctniDade Behring, Inc. · 2003 · Recalled
- 1 generation backK100130 Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample…Mitsubishi Chemical Medience CO · 2011
- This deviceK231974 PATHFAST®hs-cTnI-IIPhc Corporation · 2024
- Descendant · cites it directly · 1 of its ownK240984 i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK253051 i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981098 | Stratus CS Cardiac Troponin I Testpak | Dade Behring, Inc. | 1998 | 1 |
| −3 | K984093 | Stratus (R) CS Cardiac Troponin I (Trop) Testpak | Dade Behring, Inc. | 1998 | — |
| −2 | K033487 | Stratus CS Acute Care Troponin I Testpak, Model Cctni | Dade Behring, Inc. | 2003 | 1 |
| −1 | K100130 | Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2 | Mitsubishi Chemical Medience CO | 2011 | — |
| 0 (this device) | 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 | — |
| +2 | K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity System | Abbott Point of Care, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K100130 | Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2Summary page 5…62.1215 Creatine Phosphokinase/creatine kinase or isoenzymes test system Product code: MMI Legally marketed device claiming equivalence: PATHFAST® cTnI-II (k100130) Device description: The PATHFAST® hs-cTnI-II test is a chemiluminescent enzyme immunoassay performed on the PATHFAST®… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 System | 2025 | 1 |
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 26 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K240984 (Abbott Point of Care, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K100130.
How does its category compare?
All MMI devicesMMI Immunoassay Method, Troponin Subunit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
PA1HFAST® hs-cTnl-Il is an in vitro diagnostic test for the quantitative measurement of cardiac Troponin I (cTnl) in heparinized or EDTA whole blood and plasma. Measurements of cardiac Troponin I are used as an aid in the diagnosis of acute myocardial infarction (AMI). PA1HFAST® hs-cTnl-II is for use in clinical laboratory or point of care (POC) settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231974 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231974: PATHFAST®hs-cTnI-II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231974
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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