# K053531: Dimension Vista Free Thyroxine Flex Reagent Cartridge and Loci 1 Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 3, 2006 after 74 days
- Product code: CEC (Radioimmunoassay, Free Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1695
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970389 (1997). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970389: Thyroid Calibrator, Dade Chemistry Systems, Inc. (1997) Summary page 1.
- (no number) ADVIA Centaur FrT4 assay: named in the summary without a submission number

## Most influential descendants
- K073604: Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge, and Loci Thyroid Calibrator, Mod (2008), 5 descendants of its own
- K130276: Dimension Exl with LM System (2013), 1 descendant 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

## Indications for use
The Dimension VistaTM Free Thyroxine Flex® reagent cartridge (ET4) is a device intended to measure Free (not protein bound) thyroxine (thyroid hormone) in serum and plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid disease. The Dimension VistaTM LOCI I Calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of Free Thyroxine (FT4), Free Triiodothyronine (FT3), and Thyroid Stimulating Hormone (TSH) in human specimens.

Source page: https://510kreport.com/device/K053531
Methodology: https://510kreport.com/methodology