# K081683: Loci Cardiac Troponin I Calibrator, Model RC621

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Jul 7, 2008 after 20 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010313 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053577: Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and Sdil Sample Diluent, Dade Behring, Inc. (2006) Summary page 1.

## Recalls of this device
- Sep 17, 2013 · Class II · Z-1926-2014: Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration.
- Nov 17, 2011 · Not classified · Z-0513-2012: Siemens Healthcare Diagnostics has confirmed positive bias on QC and Patients.
- Aug 31, 2011 · Not classified · Z-0038-2012: Internal testing has confirmed that recovery of levels 2 and 3 of LOCl Cardiac Troponin I Calibrator is lower than expected bottle value. Following calibration with LOCl Cardiac Troponin I Calibrator,

## Indications for use
The LOCI® TNI CAL is an in vitro diagnostic product for the calibration of the Cardiac Troponin I (TNI) method on the Dimension® EXLTM integrated chemistry system with LOCI® module.

Source page: https://510kreport.com/device/K081683
Methodology: https://510kreport.com/methodology