Cleared Traditional

K170049 - AssureTech Panel Dip Test, AssureTech Quick Cup 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
Combination Product No
PCCP Authorized No
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 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 - NFT Test, Amphetamine, Over The Counter

All 31
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