# K041192: Architect Stat Troponin-I Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Fisher Diagnostics
- Decided: Aug 12, 2004 after 98 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010429 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021814: Accutni and Accutni  Calibrators on the Access Immunoassay Systems, Model #33340, 33345, Beckman Coulter, Inc. (2002) Summary page 1.

## Recalls of this device
- Jul 26, 2022 · Class II · Z-1660-2022: 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: 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 recalibrati
- Mar 8, 2007 · Not classified · Z-0855-2007: 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 ma
- Dec 21, 2005 · Not classified · Z-0513-06: There has been an increase in customer complaints observed for failure to calibrate or inability to generate patient result errors.

## Indications for use
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.

Source page: https://510kreport.com/device/K041192
Methodology: https://510kreport.com/methodology