# K040866: First Response One-Step Digital Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Armkel, LLC
- Decided: Oct 19, 2004 after 200 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.
No later device cites it as a predicate yet.
0 of 3 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.
- K030659: Clearblue Easy Digital Pregnancy Test, Unipath, Ltd. (2003) Summary page 1.

## Indications for use
The FIRST RESPONSE® One-Step Digital Pregnancy Test is an in vitro diagnostic test device that incorporates a digital read out of the test result for the early detection of pregnancy (hCG in urine) by the lay user prior to the expected menses

Source page: https://510kreport.com/device/K040866
Methodology: https://510kreport.com/methodology