Cleared Traditional

K981314 - VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE

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

K981314 · Sun Biomedical Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K981314

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
Combination Product No
PCCP Authorized No
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.

DJR Device Classification - Class 2, Special Controls

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 57
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