Cleared Traditional

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

K863913 is an FDA 510(k) clearance for THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT, manufactured by Diagnostic Products Corp.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K863913

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.

DOE Device Classification - Class 2, Special Controls

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.

All 8
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