Cleared Traditional

K250117 - FaStep Pregnancy Rapid Test Cassette (FDA 510(k) Clearance)

Also includes:
Fastep HCG Rapid Test Cassette

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250117 · Assure Tech., LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
28d
Days
Class 2
Risk

K250117 is an FDA 510(k) clearance for the FaStep Pregnancy Rapid Test Cassette. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Assure Tech., LLC (Wilmington, US). The FDA issued a Cleared decision on February 13, 2025 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Assure Tech., LLC devices

Submission Details

510(k) Number K250117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2025
Decision Date February 13, 2025
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Consultant

LSI International, Inc.
Jenny Xia

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 225
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K250117.
MissLan® Early Detection 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
Synthgene Home Test HCG Test Strip
K242135 · Nanjing Synthgene Medical Technology Co., Ltd. · Jan 2025
FaStep Early Pregnancy Rapid Test Strip
K243573 · Assure Tech., LLC · Jan 2025
iHealth® Early Pregnancy Test
K241394 · Andon Health Co, Ltd. · Dec 2024
HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
K240242 · Anhui Deepblue Medical Technology Co., Ltd. · Oct 2024