# K081103: Loci Thyroid Calibrator with Model RC610

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: May 23, 2008 after 35 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K970389 (1997). 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)
- K073604: Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge, and Loci Thyroid Calibrator, Mod, Dade Behring, Inc. (2008) Summary page 1.

## Indications for use
The LOCI Thyroid Calibrator is an in vitro diagnostic product for the calibration of the FT4L and TSHL methods on the Dimension® EXL TM with LM system.

Source page: https://510kreport.com/device/K081103
Methodology: https://510kreport.com/methodology