Cleared Traditional

K981314 - VISUALINE II (ALSO KNOWN AS SUNLINE) ME...

K981314 is the FDA 510(k) clearance for VISUALINE II (ALSO KNOWN AS SUNLINE) ME... by Sun Biomedical Laboratories, Inc.. It is a Class 2 Chemistry device (product code DJR) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K981314 · Sun Biomedical Laboratories, Inc. · Chemistry device
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Sep 1998
Decision
147d
Days
Class 2
Risk

K981314 is an FDA 510(k) clearance for the VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Sun Biomedical Laboratories, Inc. (Blackwood, US). The FDA issued a Cleared decision on September 4, 1998 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3620 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Sun Biomedical Laboratories, Inc. devices

Submission Details

510(k) Number K981314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1998
Decision Date September 04, 1998
Days to Decision 147 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 88d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJR Enzyme Immunoassay, Methadone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3620
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 Chemistry devices follow this clearance model.

Regulatory Peers - DJR Enzyme Immunoassay, Methadone

All 48
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K981314.
ACCUSIGN MTD, BIOSIGN MTD
K991080 · Princeton BioMeditech Corp. · Apr 1999
QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153
K982938 · Phamatech · Feb 1999
MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE
K983703 · Roche Diagnostic Systems, Inc. · Dec 1998
CEDIA DAU EDDP ASSAY
K980746 · Boehringer Mannheim Corp. · May 1998
SYNCHRON SYSTEMS METHADONE REAGENT
K973069 · Beckman Instruments, Inc. · Sep 1997
METHADONE EIA ASSAY
K972526 · Diagnostic Reagents, Inc. · Aug 1997