# K013372: Clearblue Easy Early Result Pregnancy Test

- Pathway: 510(k) (Special)
- Applicant: Unipath, Ltd.
- Decided: Nov 9, 2001 after 29 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.
20 later devices descend from it; 1 cites it directly.
0 of 21 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
- K030258: First Response Pregnancy Test (2003), 19 descendants of its own
- K083716: First Response Early Result Pregnancy Test (Otc) (2009), 17 descendants of its own
- K123436: First Response Early Result Pregnancy Test (2013), 13 descendants of its own
- K150022: Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream (2015), 6 descendants of its own
- K123567: First Response Gold Digital Pregnancy Test (2013), 2 descendants of its own

## Indications for use
CLEARBLUE EASY is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test has a sensitivity of 50mlU/ml hCG in urine, and is indicated for use from four days before the expected missed -period.

Source page: https://510kreport.com/device/K013372
Methodology: https://510kreport.com/methodology