Cleared Traditional

K071489 - HOMECHECK MULTIPLE DRUG CUP TEST

K071489 is an FDA 510(k) clearance for HOMECHECK MULTIPLE DRUG CUP TEST, manufactured by Tianjin New Bay Bioresearch Co., Ltd.. The device is a Class 2 Toxicology device with 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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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K071489

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.

DKZ Device Classification - Class 2, Special Controls

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 185
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K071489.
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RAPIDTOX
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