# K041946: Acon Spectrum Urine/Serum Pregnancy Test Device

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Aug 16, 2004 after 28 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 K993065 (1999). 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)
- K993065: Acon Combo Pregnancy, ACON Laboratories, Inc. (1999) Summary page 2.

## Most influential descendants
- K071030: Bionexia HCG Pregnancy Serum/Urine Cassette and Dipstick Tests, Models 08-HCGC and 02-HCGC (2007), 0 descendants of its own

## Indications for use
The ACON SPECTRUM Urine/Serum Pregnancy Test Device is intended for the qualitative identification the elevated level of human Chorionic Gonadotropin (hCG) in urine and serum to aid in the determination of pregnancy. It is for healthcare professionals only.

Source page: https://510kreport.com/device/K041946
Methodology: https://510kreport.com/methodology