# K973957: Dbest One-Step HCG Serum/Urine Test

- Pathway: 510(k) (Traditional)
- Applicant: Ameritek, Inc.
- Decided: Dec 17, 1997 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 dBest One-Step hCG Serum/Urine Test is a immunoassay designed for the qualitative determination of the human chorionic gonadotropin (hCG) in serum/urine for the early detection of pregnancy. It is intended for professional and laboratory use.

Source page: https://510kreport.com/device/K973957
Methodology: https://510kreport.com/methodology