Cleared Traditional

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests (K201630) - FDA 510(k) Clearance

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

K201630 · Assure Tech. (Hangzhou) Co, Ltd. · Toxicology device
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Aug 2021
Decision
422d
Days
Class 2
Risk

K201630 is an FDA 510(k) clearance for the AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Assure Tech. (Hangzhou) Co, Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on August 12, 2021 after a review of 422 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Toxicology submissions.

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

Submission Details

510(k) Number K201630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2020
Decision Date August 12, 2021
Days to Decision 422 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
335d slower than avg
Panel avg: 87d · This submission: 422d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 88
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