Cleared Traditional

K080347 - UNISCAN -DOA SYSTEM

K080347 is the FDA 510(k) clearance for UNISCAN -DOA SYSTEM by Taiwan Unison Biotech, Inc.. It is a Class 2 Toxicology device (product code DJC) cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K080347 · Taiwan Unison Biotech, Inc. · Toxicology device
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Oct 2008
Decision
244d
Days
Class 2
Risk

K080347 is an FDA 510(k) clearance for the UNISCAN -DOA SYSTEM. Classified as Thin Layer Chromatography, Methamphetamine (product code DJC), Class II - Special Controls.

Submitted by Taiwan Unison Biotech, Inc. (Chunan, Miaoli, TW). The FDA issued a Cleared decision on October 9, 2008 after a review of 244 days - an extended review 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: 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 Taiwan Unison Biotech, Inc. devices

Submission Details

510(k) Number K080347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2008
Decision Date October 09, 2008
Days to Decision 244 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 87d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 Peers - DJC Thin Layer Chromatography, Methamphetamine

All 15
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