Cleared Traditional

K122064 - FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE

K122064 is an FDA 510(k) clearance for FORSURE ONE STEP BUPRENORPHINE CUP TEST..., manufactured by Tianjin New Bay Bioresearch Co., Ltd.. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K122064 · Tianjin New Bay Bioresearch Co., Ltd. · Toxicology device
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May 2013
Decision
298d
Days
Class 2
Risk

K122064 is an FDA 510(k) clearance for the FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE. 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 May 7, 2013 after a review of 298 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

FDA 510(k) Submission Details - K122064

510(k) Number K122064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2012
Decision Date May 07, 2013
Days to Decision 298 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
211d slower than avg
Panel avg: 87d · This submission: 298d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJG Device Classification - Class 2, Special Controls

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 188
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K122064.
RAPIDFRET ORAL FLUID ASSAY FOR OPIATES
K133642 · Biophor Diagnostics, Inc. · Jan 2014
IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY
K131168 · Immunalysis Corporation · Jan 2014
QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST
K130275 · Tianjin New Bay Bioresearch Co., Ltd. · Sep 2013
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
PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR
K123799 · Psychemedics Corp. · Feb 2013