# K250117: FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette

- Pathway: 510(k) (Traditional)
- Applicant: Assure Tech., LLC
- Decided: Feb 13, 2025 after 28 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 K973858 (1997). 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)
- K152768: Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip, Assure Tech. Co., Ltd. (2016) Summary page 6.

## Indications for use
FaStep Pregnancy Rapid Test Cassette is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in the early detection of pregnancy. For over-the-counter use. The Fastep HCG Rapid Test Cassette is a rapid visual immunoassay for the qualitative detection of Human Chorionic Gonadotropin (HCGQG) in human urine. This test is intended for use as an aid in the early detection of pregnancy. The test kits are for health care professionals use including professionals at physician’s office labs (POLs).

Source page: https://510kreport.com/device/K250117
Methodology: https://510kreport.com/methodology