# K100778: Dimension Exl Loci Thyroid Calibrator, Model RC 610A

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: May 5, 2010 after 47 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 THYR CAL is an in vitro diagnostic product for the calibration of the LOCI Free Trilodothyronine (FT3), LOCI Free Thyroxine (FT4L) and LOCI Thyroid Stimulating Hormone (TSHL) methods on the Dimension®)EXLTm integrated chemistry system with LOCI®Module.

Source page: https://510kreport.com/device/K100778
Methodology: https://510kreport.com/methodology