Cleared Traditional

K980865 - QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131

K980865 is an FDA 510(k) clearance for QUICKSCREEN PRO MULTI DRUG SCREENING TEST, manufactured by Phamatech. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K980865 · Phamatech · Toxicology device
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Apr 1998
Decision
26d
Days
Class 2
Risk

K980865 is an FDA 510(k) clearance for the QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071,.... Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on April 1, 1998 after a review of 26 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 Phamatech devices

FDA 510(k) Submission Details - K980865

510(k) Number K980865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1998
Decision Date April 01, 1998
Days to Decision 26 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
61d faster than avg
Panel avg: 87d · This submission: 26d
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 K980865.
'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME
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K974611 · Microdiagnostics, Inc. · Mar 1998
STC METHAMPHETAMINE MICRO-PLATE EIA
K972989 · OraSure Technologies, Inc. · Jan 1998
TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS
K973784 · Biosite Incorporated · Dec 1997