Cleared Traditional

K983790 - VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE

K983790 · Sun Biomedical Laboratories, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
125d
Days
-
Risk

K983790 is an FDA 510(k) clearance for the VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Sun Biomedical Laboratories, Inc. (Blackwood, US). The FDA issued a Cleared decision on March 1, 1999 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel. 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 - K983790

510(k) Number K983790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1998
Decision Date March 01, 1999
Days to Decision 125 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
38d slower than avg
Panel avg: 87d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

LCM Device Classification - Class 0,

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 75
Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K983790.
BIONIKE AQ PHENCYCLIDINE (PCP) TEST
K993945 · Bionike Laboratories, Inc. · Dec 1999
REDI-TEST PCP
K991698 · Redwood Biotech, Inc. · Aug 1999
MICRO-STRIP FOR PHENCYCLIDINE METABOLITES
K991505 · Microdiagnostics, Inc. · Aug 1999
ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST
K981363 · Tcpi, Inc. · Dec 1998
AUTO-LYTE PCP EIA, MODEL #1254U
K982801 · OraSure Technologies, Inc. · Nov 1998
QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST
K981292 · Syntron Bioresearch, Inc. · May 1998