# K072500: One Step HCG Urine/Serum Test

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Apr 21, 2009 after 594 days
- Product code: DHA (System, Test, Human Chorionic Gonadotropin)
- 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
Longest line of descent: 2 generations back to K903219 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980736: Acon HCG One Step Urine/Serum Pregnancy Test, Acon Laboratories Co. (1998) Summary page 1.

## Indications for use
Wondfo One Step HCG Urine/Serum Test is an in-vitro diagnostic test for qualitative determination of human chorionic gonadotropin (HCG) in human serum or urine to aid in the early detection of pregnancy. It is intended for professional use only (Clinical Laboratory Use).

Source page: https://510kreport.com/device/K072500
Methodology: https://510kreport.com/methodology