# K980819: Biocircuits Ios Free Thyroxine (FT4) Test Cartridges Biocircuits Ios Controls

- Pathway: 510(k) (Traditional)
- Applicant: Biocircuits Corp.
- Decided: Apr 3, 1998 after 31 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
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) Dade Stratus Free Thyroxine Fluorometric Enzyme Immunoassay: named in the summary without a submission number

## Indications for use
The IOS Free Thyroxine Test Cartridges are intended to be used for the quantitative determination of free (not protein bound) thyroxine (thyroid hormone) in serum for the diagnosis and treatment of thyroid diseases. They are intended to be used with the Biocircuits IOS® instrument in clinical laboratories, physician office laboratories, and other alternate sites of use close to the point of patient care. The I0S Controls are to be used to assist in monitoring accuracy and precision in the IOS immunoassay test cartridges.

Source page: https://510kreport.com/device/K980819
Methodology: https://510kreport.com/methodology