Cleared Traditional

K990681 - DBSET MULTIDRUG SCREEN TEST KIT

K990681 is the FDA 510(k) clearance for DBSET MULTIDRUG SCREEN TEST KIT by Ameritek, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K990681 · Ameritek, Inc. · Toxicology device
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Jul 1999
Decision
135d
Days
Class 2
Risk

K990681 is an FDA 510(k) clearance for the DBSET MULTIDRUG SCREEN TEST KIT. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Ameritek, Inc. (Seattle, US). The FDA issued a Cleared decision on July 15, 1999 after a review of 135 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 Ameritek, Inc. devices

Submission Details

510(k) Number K990681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1999
Decision Date July 15, 1999
Days to Decision 135 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 87d · This submission: 135d
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 K990681.
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