# K041194: Abbott Architect Stat Troponin I Liquid Assayed Cardiac Marker Control Level L, M and H

- Pathway: 510(k) (Traditional)
- Applicant: Medical Analysis Systems, Inc.
- Decided: Aug 16, 2004 after 102 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K121084: Loci Cardiac Troponin-I Control (Low), Lctni Con L (2012), 0 descendants of its own

## Indications for use
The ARCHITECT Troponin-I Controls are for verification of the accuracy and precision of the ARCHITECT i2000SR System when used for the quantitative determination of cardiac Troponin-I in human serum and plasma. Refer to the ARCHITECT STAT Troponin-I reagent package insert for additional information.

Source page: https://510kreport.com/device/K041194
Methodology: https://510kreport.com/methodology