# K992915: One-Step Double-Chek Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Products Corp.
- Decided: Nov 18, 1999 after 80 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. The FDA summary names its predicate without a number.
- (no number) Abbott TestPack Plus: named in the summary without a submission number

## Indications for use
The One-Step Double-Chek™ Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine and serum, for the early detection of pregnancy. For Laboratory Professional Use Only.

Source page: https://510kreport.com/device/K992915
Methodology: https://510kreport.com/methodology