Cleared Traditional

K973784 - TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS

K973784 is an FDA 510(k) clearance for TRIAGE PANEL FOR DRUGS OF ABUSE, manufactured by Biosite Incorporated. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K973784 · Biosite Incorporated · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
61d
Days
Class 2
Risk

K973784 is an FDA 510(k) clearance for the TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRI.... Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on December 3, 1997 after a review of 61 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 Biosite Incorporated devices

FDA 510(k) Submission Details - K973784

510(k) Number K973784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1997
Decision Date December 03, 1997
Days to Decision 61 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
26d faster than avg
Panel avg: 87d · This submission: 61d
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 186
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K973784.
QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131
K980865 · Phamatech · Apr 1998
MICRO-STRIP FOR AMPHETAMINE METABOLITES
K974611 · Microdiagnostics, Inc. · Mar 1998
STC METHAMPHETAMINE MICRO-PLATE EIA
K972989 · OraSure Technologies, Inc. · Jan 1998
FINGERPRINT DRUG SCREENING DEVICE
K973726 · Applied Technology Ventures, LLC · Nov 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