# K991741: Biocheck HCG Enzyme Immunoassay Test Kit, Model BC-1027

- Pathway: 510(k) (Traditional)
- Applicant: Biocheck, Inc.
- Decided: Jul 22, 1999 after 62 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- Device class: 2
- Regulation: 21 CFR 862.1155
- 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 hCG ELISA is intended for the quantitative determination of human chorionic gonadotropin (hCG) in serum. This assay is to be used for the early detection of pregnancy in a clinical laboratory setting.

Source page: https://510kreport.com/device/K991741
Methodology: https://510kreport.com/methodology