Cleared Traditional

K943248 - VISUALINE II MORPHINE/OPIATES/HEROIN

K943248 is an FDA 510(k) clearance for VISUALINE II MORPHINE/OPIATES/HEROIN, manufactured by Sun Biomedical Laboratories, Inc.. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K943248 · Sun Biomedical Laboratories, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
208d
Days
Class 2
Risk

K943248 is an FDA 510(k) clearance for the VISUALINE II MORPHINE/OPIATES/HEROIN. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Sun Biomedical Laboratories, Inc. (Cherry Hill, US). The FDA issued a Cleared decision on January 30, 1995 after a review of 208 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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

FDA 510(k) Submission Details - K943248

510(k) Number K943248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1994
Decision Date January 30, 1995
Days to Decision 208 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 87d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJG Device Classification - Class 2, Special Controls

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 177
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K943248.
AXSYM OPIATES
K951287 · Abbott Laboratories · May 1995
URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950136 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1995
ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI
K945608 · Princeton BioMeditech Corp. · Feb 1995
CEDIA DAU OPIATE ASSAY
K945343 · Microgenics Corp. · Jan 1995
CEDIA DAU OPIATE ASSAY
K941195 · Microgenics Corp. · Sep 1994
CEDIA(R) DAU OPIATE ASSAY
K935346 · Microgenics Corp. · Jan 1994