# K123436: First Response Early Result Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Church & Dwight Co., Inc.
- Decided: Aug 26, 2013 after 292 days
- Product code: LCX (Kit, Test, Pregnancy, Hcg, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: 2 (0 Class I)
- 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.
13 later devices descend from it; 6 cite it directly.
0 of 18 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
- 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
- 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
- K251053: Shinetell PlusTM Digital Early Pregnancy Test (2025), 0 descendants of its own
- K243573: FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream (2025), 0 descendants of its own

## Recalls of this device
- Oct 4, 2023 · Class II · Z-0266-2024: Products were stored outside of labeled temperature requirements.
- Jun 23, 2022 · Class II · Z-1537-2022: Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

## Indications for use
The FIRST RESPONSE Early Result Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorioriic gonadotropin (hCG) in urine. The device is intended for use as an aid in early detection of pregnancy, in same 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 test again a few days after your missed period. Important note regarding positive results: Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

Source page: https://510kreport.com/device/K123436
Methodology: https://510kreport.com/methodology