# K043231: Proof Positive Electronic Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Mizuho USA, Inc.
- Decided: Apr 25, 2005 after 154 days
- Product code: LCX (Kit, Test, Pregnancy, Hcg, Over The Counter)
- 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
Proof Positive Electronic Pregnancy Test is an in-vitro diagnostic test for the qualitative determination of human chorionic godhadotropin (hCG) in urine, for the early detection of pregnancy. The test has a sensitivity of 50 mWU/mi hCG in urine. The test will be marketed for the retail or "over-the-counter" (OTC) market use.

Source page: https://510kreport.com/device/K043231
Methodology: https://510kreport.com/methodology