# K991146: TSH Enzyme Immunoassay Test Kit, Model #BC-1001

- Pathway: 510(k) (Traditional)
- Applicant: Biocheck, Inc.
- Decided: Jun 22, 1999 after 78 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The BioCheck TSH EIA is intended for the quantitative determination of thyrotropin, or thyroid stimulating hormone (TSH) in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders.

Source page: https://510kreport.com/device/K991146
Methodology: https://510kreport.com/methodology