# K993065: Acon Combo Pregnancy

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Oct 8, 1999 after 25 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: 1 (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; 3 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
- K041946: Acon Spectrum Urine/Serum Pregnancy Test Device (2004), 1 descendant of its own
- K071030: Bionexia HCG Pregnancy Serum/Urine Cassette and Dipstick Tests, Models 08-HCGC and 02-HCGC (2007), 0 descendants of its own
- K050955: Lifesign Dxpress, Model LSR2000 (2006), 0 descendants of its own
- K051841: WH Accu Test One-Step Urine/Serum Combo Pregnancy Test (2005), 0 descendants of its own

## Recalls of this device
- Aug 20, 2026 · Class II · Z-3272-2026: hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

## Indications for use
Acon™ Combo Pregnancy is intended for the rapid qualitative identification of hCG (human Chorionic Gonadotropin) in serum or urine to aid in the early determination of pregnancy. This test is for professional use.

Source page: https://510kreport.com/device/K993065
Methodology: https://510kreport.com/methodology