# K993483: Acon One Step Home Pregnancy Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Jan 20, 2000 after 98 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.
16 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K033041: Acon Quik-Check II Home Pregnancy Test Strip (2003), 15 descendants of its own
- 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

## Indications for use
ACON™ One Step Home Pregnancy Test Strip is intended for non-professional use for the qualitative identification of human chorionic gonadotropin (hCG) in urine to aid in the determination of pregnancy.

Source page: https://510kreport.com/device/K993483
Methodology: https://510kreport.com/methodology