Cleared Traditional

K173195 - DRI Hydrocodone Assay

K173195 is the FDA 510(k) clearance for DRI Hydrocodone Assay by Microgenics Corporation. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K173195 · Microgenics Corporation · Toxicology device
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Feb 2018
Decision
134d
Days
Class 2
Risk

K173195 is an FDA 510(k) clearance for the DRI Hydrocodone Assay. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Microgenics Corporation (Fremont, US). The FDA issued a Cleared decision on February 13, 2018 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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. Standard predicate reliance. 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 Corporation devices

Submission Details

510(k) Number K173195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2017
Decision Date February 13, 2018
Days to Decision 134 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
47d slower than avg
Panel avg: 87d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Toxicology devices follow this clearance model.

Regulatory Peers - DJG Enzyme Immunoassay, Opiates

All 136
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K173195.
LZI Fentanyl Enzyme Immunoassay
K181159 · Lin-Zhi International, Inc. · Dec 2018
ARK Fentanyl Assay
K180427 · ARK Diagnostics, Inc. · Jun 2018
Synermed Opiate Enzyme Immunoassay
K172416 · Infrared Laboratory Systems, LLC (Dba Synermed) · Apr 2018
CEDIA Heroin Metabolite (6-AM) Assay
K173183 · Microgenics Corporation · Nov 2017
Emit II Plus Oxycodone Assay
K172910 · Siemens Healthcare Diagnostics, Inc. · Oct 2017
Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators
K161216 · Immunalysis Corporation · Jun 2017