# K981165: Aimstep Combo Pregnancy, 1 Test, 30 Test, 50 Test, 100 Test

- Pathway: 510(k) (Traditional)
- Applicant: Germaine Laboratories, Inc.
- Decided: Apr 16, 1998 after 16 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
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
AimStep™ Combo Pregnancy is intended for the rapid qualitative identification of hCG (human Chorionic Gonadotropin) in serum or urine to aid in the early determination of pregnancy. This test is for professional use.

Source page: https://510kreport.com/device/K981165
Methodology: https://510kreport.com/methodology