Cleared Traditional

K992111 - VERDICT -II OPIATES 2000

K992111 is an FDA 510(k) clearance for VERDICT -II OPIATES 2000, manufactured by Medtox Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K992111 · Medtox Diagnostics, Inc. · Toxicology device
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Dec 1999
Decision
177d
Days
Class 2
Risk

K992111 is an FDA 510(k) clearance for the VERDICT -II OPIATES 2000. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on December 16, 1999 after a review of 177 days - an extended review cycle.

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 Medtox Diagnostics, Inc. devices

FDA 510(k) Submission Details - K992111

510(k) Number K992111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1999
Decision Date December 16, 1999
Days to Decision 177 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 87d · This submission: 177d
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 Toxicology 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 K992111.
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A
K000464 · Dade Behring, Inc. · Apr 2000
RADID DRUG SCREEN 5-PANEL TEST
K993151 · American Bio Medica Corp. · Jan 2000
AT HOME DRUG TEST, MODEL 9083
K994234 · Phamatech · Dec 1999
ROCHE COBAS INTEGRA OPIATES 300/2000
K992890 · Roche Diagnostics Corp. · Nov 1999
QUICKSTRIP ONE STEP OPIATES TEST
K993490 · Syntron Bioresearch, Inc. · Oct 1999
QUICKPAC II ONE STEP OPIATES TEST
K993491 · Syntron Bioresearch, Inc. · Oct 1999