Cleared Traditional

K170049 - AssureTech Panel Dip Test, AssureTech Quick Cup Test (FDA 510(k) Clearance)

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

K170049 · Assure Tech. (Hangzhou) Co, Ltd. · Toxicology device
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May 2017
Decision
117d
Days
Class 2
Risk

K170049 is an FDA 510(k) clearance for the AssureTech Panel Dip Test, AssureTech Quick Cup Test. Classified as Test, Amphetamine, Over The Counter (product code NFT), Class II - Special Controls.

Submitted by Assure Tech. (Hangzhou) Co, Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on May 2, 2017 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - the FDA toxicology device 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 Toxicology 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 K170049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2017
Decision Date May 02, 2017
Days to Decision 117 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 87d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NFT Test, Amphetamine, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 Toxicology devices follow this clearance model.

Regulatory Peers - NFT Test, Amphetamine, Over The Counter

All 28
Devices cleared under the same product code (NFT) and FDA review panel - the closest regulatory comparables to K170049.
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