# K991311: Total T3 Enzyme Immunoassay Test Kit, Model BC-1005

- Pathway: 510(k) (Traditional)
- Applicant: Biocheck, Inc.
- Decided: Jun 2, 1999 after 47 days
- Product code: CDP (Radioimmunoassay, Total Triiodothyronine)
- Device class: 2
- Regulation: 21 CFR 862.1710
- 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 Total T3 ElA is intended for the quantitative determination of triiodothyronine (T3) in human serum. This test is useful in the diagnosis and monitoring of thyroid diseases such as hyperthyroidism.

Source page: https://510kreport.com/device/K991311
Methodology: https://510kreport.com/methodology