# K123567: First Response Gold Digital Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Church & Dwight Co., Inc.
- Decided: Sep 10, 2013 after 294 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: 3 generations back to K992232 (1999). 4 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K083716: First Response Early Result Pregnancy Test (Otc), Church & Dwight Co., Inc. (2009)

## Most influential descendants
- K200913: Clearblue® Early Digital Pregnancy Test (2021), 0 descendants of its own
- K182328: VeriClear Digital Early Result Pregnancy Test (2019), 0 descendants of its own

## Indications for use
The FIRST RESPONSE Gold Digital Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. The device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. Important note regarding negative results: Some pregnant women will not be able to detect hCG in their urine 5 days before the expected period. If you test negative before your missed period, but think you may still be pregnant, you should re-test again a few days after your missed period. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

Source page: https://510kreport.com/device/K123567
Methodology: https://510kreport.com/methodology