Cleared Traditional

K864168 - MORPHINE ROCHE (R) EIA TEST

K864168 is an FDA 510(k) clearance for MORPHINE ROCHE EIA TEST, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code DOE cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K864168 · Roche Diagnostic Systems, Inc. · Toxicology device
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Mar 1987
Decision
143d
Days
Class 2
Risk

K864168 is an FDA 510(k) clearance for the MORPHINE ROCHE (R) EIA TEST. Classified as Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. (product code DOE), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Nutley, US). The FDA issued a Cleared decision on March 16, 1987 after a review of 143 days - within the typical 510(k) review window.

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 Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K864168

510(k) Number K864168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1986
Decision Date March 16, 1987
Days to Decision 143 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
56d slower than avg
Panel avg: 87d · This submission: 143d
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 K864168.
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
THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT
K863913 · Diagnostic Products Corp. · Mar 1987
ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE
K830460 · Hoffmann-La Roche, Inc. · Mar 1983
ABUSCREEN RADIOUMMUNOASSAY--URINE
K830462 · Hoffmann-La Roche, Inc. · Mar 1983