Cleared Traditional

K161044 - AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

K161044 is an FDA 510(k) clearance for AssureTech Methamphetamine Tests (Strip, manufactured by Assure Tech. (Hangzhou) Co, Ltd.. The device is a Class 2 Toxicology device with product code DJC cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K161044 · Assure Tech. (Hangzhou) Co, Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
84d
Days
Class 2
Risk

K161044 is an FDA 510(k) clearance for the AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Spl.... Classified as Thin Layer Chromatography, Methamphetamine (product code DJC), Class II - Special Controls.

Submitted by Assure Tech. (Hangzhou) Co, Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on July 6, 2016 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - 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: 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. (Hangzhou) Co, Ltd. devices

FDA 510(k) Submission Details - K161044

510(k) Number K161044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2016
Decision Date July 06, 2016
Days to Decision 84 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
3d faster than avg
Panel avg: 87d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJC Device Classification - Class 2, Special Controls

Product Code DJC Thin Layer Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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 - DJC Thin Layer Chromatography, Methamphetamine

All 27
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