# K023126: Ameditech Immutest HCG Pregancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Ameditech, Inc.
- Decided: Nov 18, 2002 after 60 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
The Ameditech ImmuTest hCG Pregnancy Test is an In Vitro diagnostic test for the qualitative detection of hCG in human urine to aid in the early detection of pregnancy. The sensitivity of the ImmuTest hCG Pregnancy Test is 25 mIU/ml hCG. This test kit is used to obtain a visual, qualitative result and is intended for professional and Over-the-Counter uses.

Source page: https://510kreport.com/device/K023126
Methodology: https://510kreport.com/methodology