Cleared Traditional

K863913 - THE DPC COAT-A-COUNT SERUM MORPHINE RIA...

K863913 is the FDA 510(k) clearance for THE DPC COAT-A-COUNT SERUM MORPHINE RIA... by Diagnostic Products Corp.. It is a Class 2 Toxicology device (product code DOE) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K863913 · Diagnostic Products Corp. · Toxicology device
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Mar 1987
Decision
162d
Days
Class 2
Risk

K863913 is an FDA 510(k) clearance for the THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT. Classified as Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. (product code DOE), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on March 19, 1987 after a review of 162 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3640 - 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K863913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1986
Decision Date March 19, 1987
Days to Decision 162 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 87d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DOE Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3640
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 - DOE Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep.

Devices cleared under the same product code (DOE) and FDA review panel - the closest regulatory comparables to K863913.
ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION
K951319 · Roche Diagnostic Systems, Inc. · Jun 1995
ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)
K935055 · Roche Diagnostic Systems, Inc. · Aug 1994
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)
K933572 · Immunalysis Corporation · Apr 1994
MORPHINE ROCHE (R) EIA TEST
K864168 · Roche Diagnostic Systems, Inc. · Mar 1987
ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE
K830460 · Hoffmann-La Roche, Inc. · Mar 1983
ABUSCREEN RADIOUMMUNOASSAY--URINE
K830462 · Hoffmann-La Roche, Inc. · Mar 1983