# K992232: First Response 1-Step Pregnancy

- Pathway: 510(k) (Traditional)
- Applicant: Armkel, LLC
- Decided: Dec 21, 1999 after 172 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
No predicates in its family tree.
21 later devices descend from it; 3 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)
- None. The FDA summary names its predicate without a number.
- (no number) First Response® 1-Step Pregnancy Test: named in the summary without a submission number

## Most influential descendants
- K030258: First Response Pregnancy Test (2003), 19 descendants of its own
- 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

## Indications for use
The First Recponce® 1.Step Pregnancy Test is an at-home pregnancy test marketed over-the-counter (OTC) to lay consumers. The First Response® 1-Step Pregnancy Test detects the presence of hCG in the urine as an aid in the carly diagnosis of pregnancy. The test, which can he used anytime of the day, can detect hCG as early as three days before the expected period.

Source page: https://510kreport.com/device/K992232
Methodology: https://510kreport.com/methodology