# K993203: Acon One Step Pregnancy Test Strip (Urine)

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Dec 1, 1999 after 68 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K112315: Home Pregnancy Test (2012), 0 descendants of its own
- K070921: Bionexia HCG Pregnancy Cassette and Dipstick Tests, Model 08-HCG and 02-HCG (2007), 0 descendants of its own

## Recalls of this device
- Aug 20, 2026 · Class II · Z-3273-2026: hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
- May 25, 2022 · Class II · Z-1606-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- Feb 20, 2003 · Not classified · Z-0706-03: Failure to meet sensitivity claims at end of shelf life. Potential for false negative reports.

## Indications for use
ACON™ One Step Pregnancy Test Strip (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid for the early detection of pregnancy. This test is for professional use.

Source page: https://510kreport.com/device/K993203
Methodology: https://510kreport.com/methodology