# K993317: Acon HCG One Step Pregnancy Test Device (Urine)

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Dec 1, 1999 after 58 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K123050: Egens One Step HCG Urine Pregnancy Test Kit (S) (Strip, Cassette, Midstream I and Midstream II) (2013), 2 descendants of its own
- K193132: CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream (2019), 1 descendant of its own
- K212447: SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream (2022), 0 descendants of its own
- K102760: Atlas Home Pregnancy Test (Midstream Format) Model 70172001 (2011), 0 descendants of its own

## Recalls of this device
- Aug 20, 2026 · Class II · Z-3274-2026: hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
- Jan 21, 2013 · Class III · Z-1344-2013: Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of them were incorrectly packaged into Cardinal Health hCG Combo Rapid test kit boxes. The kit box incorrectl

## Indications for use
ACON™ hCG One Step Pregnancy Test Device (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/K993317
Methodology: https://510kreport.com/methodology