Cleared Traditional

K071489 - HOMECHECK MULTIPLE DRUG CUP TEST

K071489 is the FDA 510(k) clearance for HOMECHECK MULTIPLE DRUG CUP TEST by Tianjin New Bay Bioresearch Co., Ltd.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K071489 · Tianjin New Bay Bioresearch Co., Ltd. · Toxicology device
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Mar 2008
Decision
303d
Days
Class 2
Risk

K071489 is an FDA 510(k) clearance for the HOMECHECK MULTIPLE DRUG CUP TEST. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Tianjin New Bay Bioresearch Co., Ltd. (Carlsbad, US). The FDA issued a Cleared decision on March 28, 2008 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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. Elevated predicate reliance profile. 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 K071489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2007
Decision Date March 28, 2008
Days to Decision 303 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
216d slower than avg
Panel avg: 87d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 126
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