Cleared Traditional

K233174 - FaStep™ Pregnancy Rapid Test Strip (FDA 510(k) Clearance)

Also includes:
FaStep™ Pregnancy Rapid Test Midstream

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

K233174 · Assure Tech. (Hangzhou) Co, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
130d
Days
Class 2
Risk

K233174 is an FDA 510(k) clearance for the FaStep™ Pregnancy Rapid Test Strip. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Assure Tech. (Hangzhou) Co, Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on February 5, 2024 after a review of 130 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Assure Tech. (Hangzhou) Co, Ltd. devices

Submission Details

510(k) Number K233174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 88d · This submission: 130d
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
Joe Shia

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 K233174.
MissLan® Early Detection Digital Pregnancy Test
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Shinetell PlusTM Digital Early Pregnancy Test
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FaStep Pregnancy Rapid Test Cassette
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Synthgene Home Test HCG Test Strip
K242135 · Nanjing Synthgene Medical Technology Co., Ltd. · Jan 2025
FaStep Early Pregnancy Rapid Test Strip
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K241394 · Andon Health Co, Ltd. · Dec 2024