# K030659: Clearblue Easy Digital Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Unipath, Ltd.
- Decided: May 2, 2003 after 60 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K040866: First Response One-Step Digital Pregnancy Test (2004), 0 descendants of its own

## Indications for use
CLEARBLUE EASY DIGITAL PREGNANCY TEST is an over-the-counter qualitative urine hCG test which is intended for the detection of pregnancy. The test has a sensitivity of 50mIU/mL hCG in urine, and can be used from the first day of the missed period.

Source page: https://510kreport.com/device/K030659
Methodology: https://510kreport.com/methodology