# K980736: Acon HCG One Step Urine/Serum Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Acon Laboratories Co.
- Decided: Apr 16, 1998 after 50 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- 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 K903219 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K903219: Abbott Testpack Plus TM HCG-Combo, Abbott Laboratories (1990) Summary page 2.

## Most influential descendants
- K072500: One Step HCG Urine/Serum Test (2009), 0 descendants of its own

## Indications for use
The ACON hCG Urine/Serum One Step Pregnancy Test is a rapid qualitative chromatographic immunoassay for the detection of human chorionic gonadotropin in urine or serum. The ACON hCG Urine/Serum One Step Pregnancy Test is indicated for use as an aid in the early detection of pragnancy. This device is intended to be used in the clinical laboratory and/or physician's office.

Source page: https://510kreport.com/device/K980736
Methodology: https://510kreport.com/methodology