Cleared Traditional

K042988 - RAPID ONE STEP BUPRENORPHINE TEST CARD

K042988 is an FDA 510(k) clearance for RAPID ONE STEP BUPRENORPHINE TEST CARD, manufactured by Tianjin New Bay Bioresearch Co., Ltd.. The device is a Class 2 Chemistry device with product code DJG cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K042988 · Tianjin New Bay Bioresearch Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
195d
Days
Class 2
Risk

K042988 is an FDA 510(k) clearance for the RAPID ONE STEP BUPRENORPHINE TEST CARD. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Tianjin New Bay Bioresearch Co., Ltd. (Carlsbad, US). The FDA issued a Cleared decision on May 12, 2005 after a review of 195 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3650 - the FDA in vitro diagnostics and chemistry 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 Chemistry 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 - K042988

510(k) Number K042988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2004
Decision Date May 12, 2005
Days to Decision 195 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 88d · This submission: 195d
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 Chemistry 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 K042988.
IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS
K051626 · Immunalysis Corporation · Oct 2005
QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES)
K042725 · Quest Diagnostics, Inc. · Jul 2005
OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS
K050733 · Lin-Zhi International, Inc. · Jun 2005
FOR SURE ONE STEP BUPRENORPHINE TEST STRIP
K042990 · Tianjin New Bay Bioresearch Co., Ltd. · May 2005
ACON OXY II ONE STEP OXYCODONE TEST STRIP
K043507 · ACON Laboratories, Inc. · Feb 2005
QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121
K043051 · Phamatech, Inc. · Feb 2005