# K012284: WH Accu Test Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: W.H.P.M., Inc.
- Decided: Aug 28, 2001 after 39 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) Sure Vue: named in the summary without a submission number

## Indications for use
The WH Accu Test™ Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. For Laboratory Professional Use Only. This device is not for use in the Over the Counter market.

Source page: https://510kreport.com/device/K012284
Methodology: https://510kreport.com/methodology