Cleared Traditional

K043051 - QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121

K043051 is an FDA 510(k) clearance for QUICKSCREEN OXYCODONE TEST, manufactured by Phamatech, Inc.. The device is a Class 2 Chemistry device with product code DJG cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K043051 · Phamatech, Inc. · Chemistry device
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Feb 2005
Decision
95d
Days
Class 2
Risk

K043051 is an FDA 510(k) clearance for the QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Phamatech, Inc. (San Diego, US). The FDA issued a Cleared decision on February 7, 2005 after a review of 95 days - within the typical 510(k) review window.

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 Phamatech, Inc. devices

FDA 510(k) Submission Details - K043051

510(k) Number K043051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2004
Decision Date February 07, 2005
Days to Decision 95 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
7d slower than avg
Panel avg: 88d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJG Device Classification - Class 2, Special Controls

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 188
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K043051.
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