Cleared Traditional

K014089 - VISUALINE II (ALSO KNOWN AS SUNLINE) BA...

K014089 is the FDA 510(k) clearance for VISUALINE II (ALSO KNOWN AS SUNLINE) BA... by Sun Biomedical Laboratories, Inc.. It is a Class 2 Toxicology device (product code DIS) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K014089 · Sun Biomedical Laboratories, Inc. · Toxicology device
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Apr 2002
Decision
135d
Days
Class 2
Risk

K014089 is an FDA 510(k) clearance for the VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Sun Biomedical Laboratories, Inc. (Blackwood, US). The FDA issued a Cleared decision on April 25, 2002 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sun Biomedical Laboratories, Inc. devices

Submission Details

510(k) Number K014089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2001
Decision Date April 25, 2002
Days to Decision 135 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
48d slower than avg
Panel avg: 87d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 - DIS Enzyme Immunoassay, Barbiturate

All 68
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K014089.
BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)
K033885 · Lin-Zhi International, Inc. · May 2004
BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT)
K032764 · Lin-Zhi International, Inc. · Nov 2003
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
K023946 · ACON Laboratories, Inc. · Feb 2003
BARBITURATES
K012996 · Abbott Laboratories · Mar 2002
ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE
K012824 · ACON Laboratories, Inc. · Nov 2001
INSTANT-VIEW BARBITURATE URINE CASSETTE TEST
K003647 · Alfa Scientific Designs, Inc. · May 2001