# K983090: Acon Midstream Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Nov 18, 1998 after 76 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: 1 generation back to K926204 (1993). 1 ancestor in all.
4 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926204: Sas One Step Pregnancy, Sa Scientific, Inc. (1993) Summary page 1.

## Most influential descendants
- K050546: Acon +/- Midstream Pregnancy Test (2005), 0 descendants of its own
- K042151: Acon Spectrum HCG Midstream Pregnancy Test (2004), 0 descendants of its own
- K032510: Acon Quik-Check II Midstream Home Pregnancy Test (2003), 0 descendants of its own
- K023037: Mid Stream Pregnancy Test (2003), 0 descendants of its own

## Indications for use
ACON™ Midstream Pregnancy Test is intended for home use (over-the-counter) for the qualitative detection of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.

Source page: https://510kreport.com/device/K983090
Methodology: https://510kreport.com/methodology