Cleared Traditional

K052520 - RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K052520 · Tianjin New Bay Bioresearch Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
222d
Days
Class 2
Risk

K052520 is an FDA 510(k) clearance for the RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETA.... 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 April 24, 2006 after a review of 222 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 K052520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2005
Decision Date April 24, 2006
Days to Decision 222 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
134d slower than avg
Panel avg: 88d · This submission: 222d
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 214
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