Cleared Traditional

K042988 - RAPID ONE STEP BUPRENORPHINE TEST CARD

K042988 is the FDA 510(k) clearance for RAPID ONE STEP BUPRENORPHINE TEST CARD by Tianjin New Bay Bioresearch Co., Ltd.. It is a Class 2 Chemistry device (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

Submission Details

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
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.

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 Chemistry 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 K042988.
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE
K060466 · ACON Laboratories, Inc. · Apr 2006
IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS
K051626 · Immunalysis Corporation · Oct 2005
OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS
K050733 · Lin-Zhi International, Inc. · Jun 2005
ACON OXY II ONE STEP OXYCODONE TEST STRIP
K043507 · ACON Laboratories, Inc. · Feb 2005
RANDOX OPIATES ASSAY
K041144 · Randox Laboratories, Ltd. · Nov 2004
CEDIA BUPRENORPHINE ASSAY
K040316 · Microgenics Corp. · Jun 2004