Cleared Traditional

K023617 - DRI METHADONE METABOLITE ENZYME IMMUNOA...

K023617 is the FDA 510(k) clearance for DRI METHADONE METABOLITE ENZYME IMMUNOA... by Microgenics Corp.. It is a Class 2 Toxicology device (product code DJR) cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K023617 · Microgenics Corp. · Toxicology device
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Aug 2003
Decision
302d
Days
Class 2
Risk

K023617 is an FDA 510(k) clearance for the DRI METHADONE METABOLITE ENZYME IMMUNOASSAY. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on August 27, 2003 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3620 - 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 Microgenics Corp. devices

Submission Details

510(k) Number K023617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2002
Decision Date August 27, 2003
Days to Decision 302 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
215d slower than avg
Panel avg: 87d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJR Enzyme Immunoassay, Methadone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3620
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 - DJR Enzyme Immunoassay, Methadone

All 47
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K023617.
METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
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K040570 · Randox Laboratories, Ltd. · May 2004
METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)
K031797 · Lin-Zhi International, Inc. · Oct 2003
METHADONE ENZYME IMMUNOASSAY
K023317 · Lin-Zhi International, Inc. · Dec 2002
ONLINE DAT II METHADONE II
K021505 · Roche Diagnostics Corp. · Jul 2002
COBAS INTEGRA ONLINE DAT II METHADONE II
K021512 · Roche Diagnostics Corp. · Jul 2002