# K961566: Biocircuits Ios TSH Test Cartridges/Thyroid Controls

- Pathway: 510(k) (Traditional)
- Applicant: Biocircuits Corp.
- Decided: Nov 18, 1996 after 209 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Stratus ultra-sensitive hTSH test: named in the summary without a submission number

## Indications for use
TSH: The IOS™ TSH Test Cartridge is to be used for the quantitative determination of thyroid stimulating hormone (TSH, thyrotropin) levels in serum using the Biocircuits IOS™ system. Thyroid Controls: The IOS™ Thyroid Controls Kit is to be used to assist in monitoring accuracy and precision in the IOS™ thyroid assays.

Source page: https://510kreport.com/device/K961566
Methodology: https://510kreport.com/methodology