Cleared Traditional

K990325 - QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING...

K990325 is the FDA 510(k) clearance for QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING... by Syntron Bioresearch, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K990325 · Syntron Bioresearch, Inc. · Toxicology device
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Optimized for regulatory review, auditing and printing
Jun 1999
Decision
142d
Days
Class 2
Risk

K990325 is an FDA 510(k) clearance for the QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Syntron Bioresearch, Inc. (Simi Valley, US). The FDA issued a Cleared decision on June 24, 1999 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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 Syntron Bioresearch, Inc. devices

Submission Details

510(k) Number K990325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1999
Decision Date June 24, 1999
Days to Decision 142 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 87d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Toxicology devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 126
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K990325.
URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A
K000460 · Dade Behring, Inc. · Apr 2000
IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5
K992632 · Diagnostic Products Corp. · Jan 2000
AT HOME DRUG TEST, MODEL 9063
K994237 · Phamatech · Dec 1999
ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8
K990399 · Roche Diagnostics Corp. · Apr 1999
ONTRAK TESTCUP-ER M2K
K990418 · Roche Diagnostics Corp. · Apr 1999
ONTRAK TESTCUP-5 M2K
K990337 · Roche Diagnostics Corp. · Feb 1999