Cleared Traditional

K011499 - VISUALINE AMPHETAMINE DIPSTRIP ASSAY

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

K011499 · Sun Biomedical Laboratories, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K011499

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
Combination Product No
PCCP Authorized No
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.

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 224
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K011499.
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
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RAPID DRUG SCREEN
K012159 · American Bio Medica Corp. · Jul 2001
LIVESURE AMPHETAMINE SCREEN TEST
K011609 · Pan Probe Biotech, Inc. · Jun 2001
VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY
K010177 · Sun Biomedical Laboratories, Inc. · May 2001
RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS
K003809 · Rapid Diagnostics, Inc. · Apr 2001
K011499 · VISUALINE AMPHETAMINE DIPSTRIP ASSAY
Download PDF FDA Summary Sun Biomedical Labora…