Cleared Traditional

K973726 - FINGERPRINT DRUG SCREENING DEVICE

K973726 is the FDA 510(k) clearance for FINGERPRINT DRUG SCREENING DEVICE by Applied Technology Ventures, LLC. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K973726 · Applied Technology Ventures, LLC · Toxicology device
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Nov 1997
Decision
37d
Days
Class 2
Risk

K973726 is an FDA 510(k) clearance for the FINGERPRINT DRUG SCREENING DEVICE. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Applied Technology Ventures, LLC (Herndon, US). The FDA issued a Cleared decision on November 6, 1997 after a review of 37 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Applied Technology Ventures, LLC devices

Submission Details

510(k) Number K973726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1997
Decision Date November 06, 1997
Days to Decision 37 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
50d faster than avg
Panel avg: 87d · This submission: 37d
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 K973726.
MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES
K983699 · Roche Diagnostic Systems, Inc. · Dec 1998
QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131
K980865 · Phamatech · Apr 1998
TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS
K973784 · Biosite Incorporated · Dec 1997
ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON
K973075 · Roche Diagnostic Systems, Inc. · Oct 1997
ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION
K972891 · Roche Diagnostic Systems, Inc. · Oct 1997
ONTRAK TESTCUP AMPHETAMINES
K962411 · Roche Diagnostic Systems, Inc. · Oct 1996