# K081074: Dimension TSHL Flex Reagent Cartridge and TSH Sample Diluent with Models RF 612 and KD691

- Pathway: 510(k) (Special)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: May 23, 2008 after 37 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- 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: 1 generation back to K060090 (2006). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060090: Dimension Vista Thyroid Stimulating Hormone Flex Reagent Cartridge, Dade Behring, Inc. (2006) Summary page 1.

## Most influential descendants
- K243570: Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) (2025), 0 descendants of its own
- K140842: Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci Thyroid Stimulating Hormone Flex Reagent Cart (2014), 0 descendants of its own

## Recalls of this device
- May 10, 2013 · Class II · Z-1882-2013: A rare variant of TSH, identified in a small cluster of patients, is not detected.
- May 10, 2013 · Class II · Z-1883-2013: A rare variant of TSH, identified in a small cluster of patients, is not detected.
- Apr 12, 2010 · Not classified · Z-0459-2011: Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaking cartridges may result in inaccurate t

## 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® EXLTM with LM System. Measurements of TSH are used in the diagnosis and monitoring of thyroid disease. The TSH Sample Diluent is an in vitro diagnostic product fot manual dilution of samples with elevated TSH results processed on the Dimension Vista® and Dimension® EXLTM with LM systems.

Source page: https://510kreport.com/device/K081074
Methodology: https://510kreport.com/methodology