# K032661: Acon Quick-Check II Home Pregnancy Test Device (Cassette)

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Oct 14, 2003 after 47 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
Longest line of descent: 1 generation back to K012215 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012215: Quik-Check Home Pregnancy Test, ACON Laboratories, Inc. (2001)

## Indications for use
The ACON Quik-Check II Home Pregnancy Test Device is intended for non-professional, over-the counter use for the qualitative identification the elevated level of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.

Source page: https://510kreport.com/device/K032661
Methodology: https://510kreport.com/methodology