Cleared Traditional

K170049 - AssureTech Panel Dip Test

K170049 is an FDA 510(k) clearance for AssureTech Panel Dip Test, manufactured by Assure Tech. (Hangzhou) Co, Ltd.. The device is a Class 2 Toxicology device with product code NFT cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K170049 · Assure Tech. (Hangzhou) Co, Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K170049

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.

NFT Device Classification - Class 2, Special Controls

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 29
Devices cleared under the same product code (NFT) and FDA review panel - the closest regulatory comparables to K170049.
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
K181968 · Safecare Biotech (Hangzhou) Co., Ltd. · Aug 2018
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
K180349 · Assure Tech. (Hangzhou) Co, Ltd. · Apr 2018
First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana
K171695 · W.H.P.M., Inc. · Feb 2018