# K033041: Acon Quik-Check II Home Pregnancy Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Nov 21, 2003 after 53 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 K993483 (2000). 1 ancestor in all.
15 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993483: Acon One Step Home Pregnancy Test Strip, ACON Laboratories, Inc. (2000) Summary page 1.

## Most influential descendants
- K043443: One Step HCG Urine Pregnancy Test (2005), 14 descendants of its own
- K173229: Preview Digital Pregnancy Test (2018), 2 descendants of its own
- K222305: MissLan™ Digital Pregnancy Rapid Test (2022), 1 descendant of its own
- K200133: hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream (2020), 1 descendant of its own
- K192123: HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream (2019), 1 descendant of its own

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

Source page: https://510kreport.com/device/K033041
Methodology: https://510kreport.com/methodology