# K213379: Clearblue ® Early Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Spd Swiss Precision Diagnostics GmbH
- Decided: Sep 21, 2022 after 343 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: 4 generations back to K992232 (1999). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123436: First Response Early Result Pregnancy Test, Church & Dwight Co., Inc. (2013) Summary page 4.

## Most influential descendants
- K241394: iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip (2024), 0 descendants of its own

## Indications for use
The Clearblue® Early Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period. The test is intended for home use.

Source page: https://510kreport.com/device/K213379
Methodology: https://510kreport.com/methodology