# K991432: Biocheck Total T4 Enzyme Immunoassay Test Kit, Model BC-1007

- Pathway: 510(k) (Traditional)
- Applicant: Biocheck, Inc.
- Decided: Jun 2, 1999 after 37 days
- Product code: KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1700
- Recalls of this device: 2 (0 Class I)
- 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.

## Recalls of this device
- Oct 18, 2021 · Class II · Z-0310-2022: Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples.
- Oct 14, 2021 · Class II · Z-0214-2022: Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.

## Indications for use
The BioCheck Total T4 EIA is intended for the quantitative determination of total thyroxine (T4) in human serum. This test is useful in the diagnosis and treatment of thyroid diseases.

Source page: https://510kreport.com/device/K991432
Methodology: https://510kreport.com/methodology