# K121084: Loci Cardiac Troponin-I Control (Low), Lctni Con L

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: May 9, 2012 after 29 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
Longest line of descent: 1 generation back to K041194 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041194: Abbott Architect Stat Troponin I Liquid Assayed Cardiac Marker Control Level L, M and H, Medical Analysis Systems, Inc. (2004) Summary page 1.

## Indications for use
LOCI Cardiac Troponin-I Control (low), LCTNI CON L LCTNI CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias in the quantitative determination of cardiac troponin-I (CTNI/TNI) on the Dimension Vista® System and Dimension® EXL™ integrated chemistry system with LOCI® module. LOCI Cardiac Troponin-I Control (medium), LCTNI CON M LCTNI CON M is an assayed, mid level, intralaboratory quality control for assessment of precision and analytical bias in the quantitative determination of cardiac troponin-I (CTNI/TNI) on the Dimension Vista® System and Dimension® EXL™ integrated chemistry system with LOCI® module. LOCI Cardiac Troponin-I Control (high), LCTNI CON H LCTNI CON H is an assayed, high level, intralaboratory quality control for assessment of precision and analytical bias in the quantitative determination of cardiac troponin-I (CTNI/TNI) on the Dimension Vista® System and Dimension® EXL™ integrated chemistry system with LOCI® module.

Source page: https://510kreport.com/device/K121084
Methodology: https://510kreport.com/methodology