510(k) · Cleared
ClearedPathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitsubishi Chemical Medience CO · MMI Immunoassay Method, Troponin Subunit
Cleared on May 16, 2011 as substantially equivalent to K033487 (Dade Behring, Inc., 2003) after a 482-day review. Its family tree reaches back 3 generations to 1998. 4 later devices descend from it.
- Decided
- May 16, 2011
- Review
- 482 days
- Class
- Class II
- Product code
- MMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K981098 (1998). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK981098 Stratus CS Cardiac Troponin I TestpakDade Behring, Inc. · 1998 · Recalled
- 2 generations backK984093 Stratus (R) CS Cardiac Troponin I (Trop) TestpakDade Behring, Inc. · 1998
- 1 generation backK033487 Stratus CS Acute Care Troponin I Testpak, Model CctniDade Behring, Inc. · 2003 · Recalled
- This deviceK100130 Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample…Mitsubishi Chemical Medience CO · 2011
- Descendant · cites it directly · 2 of its ownK231974 PATHFAST®hs-cTnI-IIPhc Corporation · 2024
- Descendant · 2 generations on · 1 of its ownK240984 i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK253051 i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK130603 Pathfast CTNL CalibratorsMitsubishi Chemical Medience Corporation · 2014
Most influential descendants
Showing 4 of 4 · See all- K231974PATHFAST®hs-cTnI-IIPhc Corporation · 2024 · cites it directly2descendants
- K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2025 · 2 generations on1descendant
- K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc. · 2026 · 3 generations on0descendants
- K130603Pathfast CTNL CalibratorsMitsubishi Chemical Medience Corporation · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981098 | Stratus CS Cardiac Troponin I Testpak | Dade Behring, Inc. | 1998 | 1 |
| −2 | K984093 | Stratus (R) CS Cardiac Troponin I (Trop) Testpak | Dade Behring, Inc. | 1998 | — |
| −1 | K033487 | Stratus CS Acute Care Troponin I Testpak, Model Cctni | Dade Behring, Inc. | 2003 | 1 |
| 0 (this device) | K100130 | Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2 | Mitsubishi Chemical Medience CO | 2011 | — |
| +1 | K231974 | PATHFAST®hs-cTnI-II | Phc Corporation | 2024 | — |
| +2 | K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2025 | — |
| +3 | K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity System | Abbott Point of Care, Inc. | 2026 | — |
| +1 | K130603 | Pathfast CTNL Calibrators | Mitsubishi Chemical Medience Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2024 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K033487 | Stratus CS Acute Care Troponin I Testpak, Model CctniSummary page 8…the reagent lot. SUBSTANTIAL EQUIVALENCE: The PATHFAST cTnI-II assay is substantially equivalent to the Stratus CS cTnI TestPak (predicate device – K033487). The following table summarizes the similarities and differences. Comparison between PATHFAST cTnI-II and predicate devic… | 2003 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K231974 (Phc Corporation, 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K033487.
How does its category compare?
All MMI devicesMMI Immunoassay Method, Troponin Subunit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
PATHFAST® cTnI-II test is an in vitro diagnostic test for the quantitative measurement of cardiac Troponin I (cTnI) 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. This method is for use in clinical laboratory or point of care (POC) settings.
The PATHFAST® cTnI Calibrators are for calibration of the PATHFAST® system when used for the quantitative determination of cardiac Troponin I in human heparinized or EDTA whole blood and plasma.
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/K100130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100130: Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100130
Report an extraction error
Are you the manufacturer?
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