Cleared Traditional

K935055 - ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)

K935055 is an FDA 510(k) clearance for ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MO..., 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 293-day FDA review.

K935055 · Roche Diagnostic Systems, Inc. · Toxicology device
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Aug 1994
Decision
293d
Days
Class 2
Risk

K935055 is an FDA 510(k) clearance for the ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF). Classified as Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. (product code DOE), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on August 9, 1994 after a review of 293 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 Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K935055

510(k) Number K935055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1993
Decision Date August 09, 1994
Days to Decision 293 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 87d · This submission: 293d
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
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