# K140859: Dimension Vista Free Thyroxine Flex Reagent Cartridge, FT4, Dimension Vista Thyroid Stimulating Hormone Flex Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Nov 26, 2014 after 237 days
- Product code: CEC (Radioimmunoassay, Free Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1695
- 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: 2 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)
- K053531: Dimension Vista Free Thyroxine Flex Reagent Cartridge and Loci 1 Calibrator, Dade Behring, Inc. (2006) Summary page 6.
- K060090: Dimension Vista Thyroid Stimulating Hormone Flex Reagent Cartridge, Dade Behring, Inc. (2006) Summary page 6.

## Recalls of this device
- Jan 2, 2018 · Class II · Z-1673-2018: The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine,
- Mar 21, 2017 · Class II · Z-2611-2017: The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FE
- Apr 20, 2015 · Class II · Z-1708-2015: Dimension Vista LOCI Thyroid Stimulating Hormone (TSH) Lot 14237AA may produce falsely depressed results ranging from -23% to -96% near the end of the well set due to inadequate reagent volume in a Fl

## Indications for use
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. The TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista® System. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

Source page: https://510kreport.com/device/K140859
Methodology: https://510kreport.com/methodology