Cleared Traditional

FaStep? Pregnancy Rapid Test Strip; FaStep? Pregnancy Rapid Test Midstream

K233174 · Assure Tech. (Hangzhou) Co, Ltd. · Chemistry
Feb 2024
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K233174 is an FDA 510(k) clearance for the FaStep? Pregnancy Rapid Test Strip; FaStep? Pregnancy Rapid Test Midstream, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Assure Tech. (Hangzhou) Co, Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on February 5, 2024, 130 days after receiving the submission on September 28, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K233174 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2023
Decision Date February 05, 2024
Days to Decision 130 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

Similar Devices — LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 225
MissLan? Early Detection Digital Pregnancy Test; MissLan? Early Result Digital Pregnancy Test
K251040 · Guangzhou Decheng Biotechnology Co., Ltd. · Sep 2025
Shinetell PlusTM Digital Early Pregnancy Test
K251053 · Hangzhou AllTest Biotech Co., Ltd. · Jul 2025
FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
K250117 · Assure Tech., LLC · Feb 2025
Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
K242135 · Nanjing Synthgene Medical Technology Co., Ltd. · Jan 2025
FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream
K243573 · Assure Tech., LLC · Jan 2025
iHealth? Early Pregnancy Test; iHealth? Early Pregnancy Test Strip
K241394 · Andon Health Co, Ltd. · Dec 2024

More from Assure Tech. (Hangzhou) Co,...

View all
AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
K201630 · DJG · Aug 2021
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
K181768 · NFT · Aug 2018
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
K180349 · NFT · Apr 2018
AssureTech Panel Dip Test, AssureTech Quick Cup Test
K170049 · NFT · May 2017
AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
K161044 · DJC · Jul 2016