# K130456: Wunder Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: James Nguyen
- Decided: Apr 8, 2014 after 410 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 K061257 (2007). 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)
- K061257: Dbest HCG Panel Test Kit, Ameritek USA, Inc. (2007) Summary page 2.

## Indications for use
Wunder Pregnancy Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic goriadotropin (hCG) in human urine. The device is visually read as an aid for the early detection of pregnancy and intended for in vitro single use. This test is for prescription use including at point-of-care sites.

Source page: https://510kreport.com/device/K130456
Methodology: https://510kreport.com/methodology