# K053452: Pure-Aid Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Bio Focus Co., Lt.
- Decided: May 25, 2006 after 164 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
Pure-Aid Pregnancy Test is intended for the qualitative determination of Human Chorionic Gonadotropin (hCG) in Human urine. The test is for Over-The-Counter use. The test is for the early detection of pregnancy.

Source page: https://510kreport.com/device/K053452
Methodology: https://510kreport.com/methodology