510(k) · Cleared
Recalled · Class II · 2022Architect Stat Troponin-I Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher Diagnostics · MMI Immunoassay Method, Troponin Subunit
Cleared on Aug 12, 2004 as substantially equivalent to K021814 (Beckman Coulter, Inc., 2002) after a 98-day review. Its family tree reaches back 2 generations to 2001. It has been recalled 4 times.
- Decided
- Aug 12, 2004
- Review
- 98 days
- Class
- Class II
- Product code
- MMI
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010429 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK010429 Accutni and Accutni Calibrators on the Access Immunoassay System #…Beckman Coulter, Inc. · 2001 · Recalled
- 1 generation backK021814 Accutni and Accutni Calibrators on the Access Immunoassay Systems…Beckman Coulter, Inc. · 2002 · Recalled
- This deviceK041192 Architect Stat Troponin-I ImmunoassayFisher Diagnostics · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010429 | Accutni and Accutni Calibrators on the Access Immunoassay System # 33340, 33345 | Beckman Coulter, Inc. | 2001 | 3 |
| −1 | K021814 | Accutni and Accutni Calibrators on the Access Immunoassay Systems, Model… | Beckman Coulter, Inc. | 2002 | 3 |
| 0 (this device) | K041192 | Architect Stat Troponin-I Immunoassay | Fisher Diagnostics | 2004 | — |
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 |
|---|---|---|---|
| * | K021814 | Accutni and Accutni Calibrators on the Access Immunoassay Systems, Model #33340, 33345Summary page 1…ulation: 21 CFR 862.1215 FDA Panel: Clinical Chemistry (75) Product Code: MMI Identification of Predicate Device: Access® AccuTnl Assay (K021814) Intended Use of the Device: ARCHITECT STAT Troponin-l is a Chemiluminescent Microparticle Immunoassay (CMIA)… | 2002 |
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 |
|---|---|---|---|---|
| Jul 26, 2022 | Class II | Z-1660-2022 | Under Investigation by firm | One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component. |
| Apr 11, 2012 | Not classified | Z-1509-2012 | Material/Component Contamination | The lot of Troponin-I is demonstrating a shift in expected results in some cases, and varies from kit to kit. A concentration change of up to +/-55% could occur when switching kits without recalibrating. |
| Mar 8, 2007 | Not classified | Z-0855-2007 | Other | False Negative Results : The analytical sensitivity claim of less than or equal to 0.01 ng/mL (ug/L) might not be met for all lots of Architect STAT Troponin-I reagents, thus false negative results may occur with negative results less… |
| Dec 21, 2005 | Not classified | Z-0513-06 | Other | There has been an increase in customer complaints observed for failure to calibrate or inability to generate patient result errors. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 2 other devices also cite its predicate K021814.
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?
ARCHITECT STATTroponin-I is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of cardiac troponin-I (cTnI) in human serum and plasma on the ARCHITECT iSystem with STAT protocol capability. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI).
The ARCHITECT STATTroponin-I Calibrators are for calibration of the ARCHITECT i 2000SR System when used for the quantitative determination of cardiac Troponin-I in human serum or plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041192: Architect Stat Troponin-I Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041192
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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