# K233174: FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream

- Pathway: 510(k) (Traditional)
- Applicant: Assure Tech. (Hangzhou) Co, Ltd.
- Decided: Feb 5, 2024 after 130 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: 2 generations back to K974059 (1998). 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)
- K122907: Fastep at-Home Pregnancy, HCG, Over the Counter, Polymed Therapeutics, Inc. (2013) Summary page 4.

## Indications for use
The FaStepTM Pregnancy Rapid Test Strip is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. The test is an in-vitro diagnostic strip intended for use as an aid in the early detection of pregnancy. The FaStepTM Pregnancy Rapid Test Strip is designed for self-testing use. The FaStepTM Pregnancy Rapid Test Midstream is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotropin(hCG) in urine. The test is an in-vitro diagnostic device intended for use as an aid in the early detection of pregnancy. The FaStepTM Pregnancy Rapid Test Midstream is designed for self-testing use.

Source page: https://510kreport.com/device/K233174
Methodology: https://510kreport.com/methodology