Cleared Traditional

ROCHE OXI/FERM II (K923313) - FDA 510(k) Clearance

Class I Microbiology device.

K923313 · Roche Diagnostic Systems, Inc. · Microbiology device
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Apr 1993
Decision
272d
Days
Class 1
Risk

K923313 is an FDA 510(k) clearance for the ROCHE OXI/FERM II. Classified as Gram Negative Identification Panel (product code LQM), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on April 5, 1993 after a review of 272 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K923313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1992
Decision Date April 05, 1993
Days to Decision 272 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 102d · This submission: 272d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQM Gram Negative Identification Panel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.