# K083716: First Response Early Result Pregnancy Test (Otc)

- Pathway: 510(k) (Traditional)
- Applicant: Church & Dwight Co., Inc.
- Decided: Jun 8, 2009 after 175 days
- Product code: LCX (Kit, Test, Pregnancy, Hcg, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K992232 (1999). 3 ancestors in all.
17 later devices descend from it; 2 cite 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)
- K030258: First Response Pregnancy Test, Armkel, LLC (2003)
- K992232: First Response 1-Step Pregnancy, Armkel, LLC (1999) Summary page 1.

## Most influential descendants
- 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
- K213379: Clearblue ® Early Pregnancy Test (2022), 1 descendant of its own
- K251040: MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test (2025), 0 descendants of its own

## Recalls of this device
- Jan 25, 2023 · Class II · Z-1350-2023: Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There is also a potential for Easy Read App to be unable to reads the test results (i.e., no resul

## Indications for use
The FIRST RESPONSE® Early Result Pregnancy Test is an in vitro diagnostic home use test device intended for the early detection of pregnancy. The test may detect the pregnancy hormone (hCG), in some cases, as early as 6 days before the missed period (5 days before the expected period). This test is only intended for individual use at home. It is not intended for use in a healthcare setting. Important note regarding negative results: Some pregnant women will not be able to detect hCG in their urine 6 days before the missed 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. Important note regarding positive results: Because this test detects very low levels of hCG, there is a small chance that this test will give positive results even if you are not pregnant. Chances of this are greater for women nearing age 40 and older. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

Source page: https://510kreport.com/device/K083716
Methodology: https://510kreport.com/methodology