# K060090: Dimension Vista Thyroid Stimulating Hormone Flex Reagent Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Feb 27, 2006 after 46 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K081074: Dimension TSHL Flex Reagent Cartridge and TSH Sample Diluent with Models RF 612 and KD691 (2008), 2 descendants of its own
- K243570: Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) (2025), 0 descendants of its own
- K140859: Dimension Vista Free Thyroxine Flex Reagent Cartridge, FT4, Dimension Vista Thyroid Stimulating Hormone Flex Reagent (2014), 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-1884-2013: A rare variant of TSH, identified in a small cluster of patients, is not detected.

Source page: https://510kreport.com/device/K060090
Methodology: https://510kreport.com/methodology