Cleared Traditional

K981705 - 'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME

K981705 is an FDA 510(k) clearance for 'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME, manufactured by American Bio Medica Corp.. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K981705 · American Bio Medica Corp. · Toxicology device
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Aug 1998
Decision
105d
Days
Class 2
Risk

K981705 is an FDA 510(k) clearance for the 'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by American Bio Medica Corp. (Washington, US). The FDA issued a Cleared decision on August 27, 1998 after a review of 105 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 American Bio Medica Corp. devices

FDA 510(k) Submission Details - K981705

510(k) Number K981705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1998
Decision Date August 27, 1998
Days to Decision 105 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
18d slower than avg
Panel avg: 87d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DKZ Device Classification - Class 2, Special Controls

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 158
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K981705.
ONTRAK TESTCUP-5 M2K
K990337 · Roche Diagnostics Corp. · Feb 1999
'RAPID DRUG SCREEN' 9-PANEL
K983770 · American Bio Medica Corp. · Dec 1998
MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES
K983699 · Roche Diagnostic Systems, Inc. · Dec 1998
DBEST AMPHETAMINES TEST KIT
K981504 · Ameritek, Inc. · Aug 1998
ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST
K981197 · Tcpi, Inc. · Jun 1998
QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131
K980865 · Phamatech · Apr 1998