# K023027: Preg-Q Early Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Yd Diagnostics
- Decided: Dec 16, 2002 after 96 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 K954029 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954029: Testpack Plus HCG Urine, Abbott Laboratories (1995) Summary page 1.

## Indications for use
The Preg-Q hCG Early Pregnancy Test is a rapid visual test for the qualitative detection of hCG in urine to aid in the determination of pregnancy. This test is for over-the-counter, central laboratory, and point of care hospital use.

Source page: https://510kreport.com/device/K023027
Methodology: https://510kreport.com/methodology