# K070054: First Response Gold Digital Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Church & Dwight Co., Inc.
- Decided: May 4, 2007 after 120 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 K041404 (2004). 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)
- K041404: Clearblue Easy Easy Read Pregnancy Test, Unipath, Ltd. (2004) Summary page 1.

## Indications for use
The First Response Gold Digital Pregnancy Test is an in vitro diagnostic test device intended for the early detection of pregnancy by the lay user up to five (5) days sooner than the day of the missed period (four (4) days before the day of the expected period). The test detects human chorionic gonadotropin in urine.

Source page: https://510kreport.com/device/K070054
Methodology: https://510kreport.com/methodology