# K013857: Aimstep Pregnancy

- Pathway: 510(k) (Traditional)
- Applicant: Germaine Laboratories, Inc.
- Decided: Jan 22, 2002 after 62 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 its predicate without a number.
- (no number) Clearview™ Easy HCG Pregnancy Test: named in the summary without a submission number

## Indications for use
AimStep™ Pregnancy is intended for non-professional use for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.

Source page: https://510kreport.com/device/K013857
Methodology: https://510kreport.com/methodology