Cleared Traditional

K011499 - VISUALINE AMPHETAMINE DIPSTRIP ASSAY

K011499 is the FDA 510(k) clearance for VISUALINE AMPHETAMINE DIPSTRIP ASSAY by Sun Biomedical Laboratories, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K011499 · Sun Biomedical Laboratories, Inc. · Toxicology device
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Optimized for regulatory review, auditing and printing
Jul 2001
Decision
63d
Days
Class 2
Risk

K011499 is an FDA 510(k) clearance for the VISUALINE AMPHETAMINE DIPSTRIP ASSAY. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Sun Biomedical Laboratories, Inc. (Blackwood, US). The FDA issued a Cleared decision on July 17, 2001 after a review of 63 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 Sun Biomedical Laboratories, Inc. devices

Submission Details

510(k) Number K011499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2001
Decision Date July 17, 2001
Days to Decision 63 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 87d · This submission: 63d
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 K011499.
DRI ECSTASY ENZYME IMMUNOASSAY
K012110 · Microgenics Corp. · Aug 2001
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
K012257 · Syva Co. · Aug 2001
ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE
K011673 · ACON Laboratories, Inc. · Jul 2001
AT HOME DRUG TEST, MODEL 9063 T
K010645 · Phamatech · Mar 2001
COBAS INTEGRA AMPHETAMINES
K003865 · Roche Diagnostics Corp. · Feb 2001
INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST
K994395 · Alfa Scientific Designs, Inc. · Aug 2000