# K974368: Aimstick PBD Pregnancy

- Pathway: 510(k) (Traditional)
- Applicant: Germaine Laboratories, Inc.
- Decided: Jan 2, 1998 after 43 days
- Product code: DHA (System, Test, Human Chorionic Gonadotropin)
- 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 no predicate by number.

## Indications for use
AimStick® PBD Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy. This test is for professional use.

Source page: https://510kreport.com/device/K974368
Methodology: https://510kreport.com/methodology