# K953837: Biocircuits Ios T4 Test Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Biocircuits Corp.
- Decided: Nov 20, 1995 after 97 days
- Product code: KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1700
- 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 T4: named in the summary without a submission number

## Indications for use
The Biocircuits IOSm T4 cartridge is to be used for the quantitative determination of total thyroxine levels, as part of the Biocircuits IOSm System. The IOSm Thyroid Controls Kit is to be used to assist in monitoring accuracy and precision in the IOSm thyroid assays.

Source page: https://510kreport.com/device/K953837
Methodology: https://510kreport.com/methodology