Cleared Traditional

K130275 - QUIKSCREEN MULTI (MDMA AND OPI) OTC DRU...

K130275 is the FDA 510(k) clearance for QUIKSCREEN MULTI (MDMA AND OPI) OTC DRU... by Tianjin New Bay Bioresearch Co., Ltd.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K130275 · Tianjin New Bay Bioresearch Co., Ltd. · Toxicology device
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Sep 2013
Decision
234d
Days
Class 2
Risk

K130275 is an FDA 510(k) clearance for the QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Tianjin New Bay Bioresearch Co., Ltd. (San Diego, US). The FDA issued a Cleared decision on September 26, 2013 after a review of 234 days - an extended review cycle.

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: 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 Tianjin New Bay Bioresearch Co., Ltd. devices

Submission Details

510(k) Number K130275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2013
Decision Date September 26, 2013
Days to Decision 234 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 87d · This submission: 234d
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 Peers - DJG Enzyme Immunoassay, Opiates

All 137
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K130275.
CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)
K140089 · Guangzhou Wondfo Biotech Co., Ltd. · Apr 2014
STATUS DS OXY
K130650 · Princeton BioMeditech Corp. · Feb 2014
IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY
K131168 · Immunalysis Corporation · Jan 2014
WONDOFO MULTI-DRUG URINE TEST CUP / PANEL
K130665 · Guangzhou Wondfo Biotech Co., Ltd. · Apr 2013
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP
K130055 · Guangzhou Wondfo Biotech Co., Ltd. · Feb 2013
LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS
K120763 · Lin-Zhi International, Inc. · Jun 2012