# K042151: Acon Spectrum HCG Midstream Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Sep 9, 2004 after 31 days
- Product code: LCX (Kit, Test, Pregnancy, Hcg, Over The Counter)
- 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: 2 generations back to K926204 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983090: Acon Midstream Pregnancy Test, ACON Laboratories, Inc. (1998) Summary page 2.

## Indications for use
The ACON SPECTRUM hCG Midstream Pregnancy Test is intended for the qualitative identification of the elevated level of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. It is for over-the-counter consumer use.

Source page: https://510kreport.com/device/K042151
Methodology: https://510kreport.com/methodology