# K051841: WH Accu Test One-Step Urine/Serum Combo Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: W.H.P.M., Inc.
- Decided: Aug 22, 2005 after 46 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
Longest line of descent: 1 generation back to K993065 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993065: Acon Combo Pregnancy, ACON Laboratories, Inc. (1999) Summary page 1.

## Indications for use
The WH Accu TestTM One-Step Urine/Serum Combo Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine or serum to aid in the early detection of pregnancy. For Laboratory Professional Use Only.

Source page: https://510kreport.com/device/K051841
Methodology: https://510kreport.com/methodology