# K243570: Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Apr 25, 2025 after 158 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081074: Dimension TSHL Flex Reagent Cartridge and TSH Sample Diluent with Models RF 612 and KD691, Siemens Healthcare Diagnostics, Inc. (2008) Summary page 5.
- K073604: Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge, and Loci Thyroid Calibrator, Mod, Dade Behring, Inc. (2008) Summary page 5.

## Indications for use
The TSHL method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone (TSH, thyrotropin) in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® Module. Measurements of TSH are used in the diagnosis and monitoring of thyroid disease. The FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® module. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease.

Source page: https://510kreport.com/device/K243570
Methodology: https://510kreport.com/methodology