# K122907: Fastep at-Home Pregnancy, HCG, Over the Counter

- Pathway: 510(k) (Traditional)
- Applicant: Polymed Therapeutics, Inc.
- Decided: Mar 14, 2013 after 174 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 K974059 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974059: One Step Midstream HCG Pregnancy Test, International Newtech Development, Inc. (1998) Summary page 2.

## Most influential descendants
- K233174: FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream (2024), 0 descendants of its own

## Indications for use
The Polymed Therapeutics' Fastep T m At-home Pregnancy Test is a rapid chromatographic immunoassay for the visual, qualitative detection of human chorionic gonadotropin (hCG) in urine specimen to aid in the early detection of pregnancy. Polymed Therapeutics' FastepTM At-Home Pregnancy Test is intended to be distributed for Over-the-Counter (OTC) use.

Source page: https://510kreport.com/device/K122907
Methodology: https://510kreport.com/methodology