Cleared Traditional

K130082 - GENPRIME DRUGS OF ABUSE READER SYSTEM

K130082 is an FDA 510(k) clearance for GENPRIME DRUGS OF ABUSE READER SYSTEM, manufactured by Genprime, Inc.. The device is a Class 2 Chemistry device with product code DKZ cleared through the Traditional 510(k) pathway after a 340-day FDA review.

K130082 · Genprime, Inc. · Chemistry device
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Dec 2013
Decision
340d
Days
Class 2
Risk

K130082 is an FDA 510(k) clearance for the GENPRIME DRUGS OF ABUSE READER SYSTEM. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Genprime, Inc. (Oms River, US). The FDA issued a Cleared decision on December 20, 2013 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3100 - 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. Elevated predicate reliance profile. 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 Genprime, Inc. devices

FDA 510(k) Submission Details - K130082

510(k) Number K130082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2013
Decision Date December 20, 2013
Days to Decision 340 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
252d slower than avg
Panel avg: 88d · This submission: 340d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 184
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