# K030258: First Response Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Armkel, LLC
- Decided: Feb 25, 2003 after 32 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 K992232 (1999). 2 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992232: First Response 1-Step Pregnancy, Armkel, LLC (1999) Summary page 1.
- K013372: Clearblue Easy Early Result Pregnancy Test, Unipath, Ltd. (2001)

## Most influential descendants
- K083716: First Response Early Result Pregnancy Test (Otc) (2009), 17 descendants of its own
- 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

## Indications for use
The FIRST RESPONSE®1-Step Pregnancy Test is an in vitro diagnostic test device intended for the early detection of pregnancy by the lay user up to four (4) days prior to the expected menses

Source page: https://510kreport.com/device/K030258
Methodology: https://510kreport.com/methodology