# K970389: Thyroid Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Chemistry Systems, Inc.
- Decided: Feb 18, 1997 after 15 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) aca® plus FT4 Calibrator: named in the summary without a submission number
- (no number) aca® plus TSH Calibrator: named in the summary without a submission number

## Most influential descendants
- K053531: Dimension Vista Free Thyroxine Flex Reagent Cartridge and Loci 1 Calibrator (2006), 7 descendants of its own
- 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

## Indications for use
The Thyroid Calibrator is intended to be used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to calibrate the FT4 and TSH methods.

Source page: https://510kreport.com/device/K970389
Methodology: https://510kreport.com/methodology