Cleared Traditional

K080347 - UNISCAN -DOA SYSTEM

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

K080347 · Taiwan Unison Biotech, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K080347

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
Combination Product No
PCCP Authorized No
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.

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

Center For Measurement Standards of Industrial

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 30
Devices cleared under the same product code (DJC) and FDA review panel - the closest regulatory comparables to K080347.
OralTox Oral Fluid Drug Test
K171403 · Premier Biotech, Inc. · Feb 2018
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 · Assure Tech. (Hangzhou) Co, Ltd. · Jul 2016
WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)
K132630 · Guangzhou Wondfo Biotech Co., Ltd. · Sep 2013
ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000
K060355 · Acro Biotech, LLC · Aug 2006
MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT
K060896 · Varian, Inc. · Jun 2006
ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST
K053033 · Acro Biotech, LLC · Jun 2006
K080347 · UNISCAN -DOA SYSTEM
Download PDF FDA Summary Taiwan Unison Biotech…