Cleared Traditional

K923313 - ROCHE OXI/FERM II

K923313 is an FDA 510(k) clearance for ROCHE OXI/FERM II, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 1 Microbiology device with product code LQM cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K923313 · Roche Diagnostic Systems, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K923313

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.

LQM Device Classification - Class 1, General Controls

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.

Regulatory Peers - LQM Gram Negative Identification Panel

Devices cleared under the same product code (LQM) and FDA review panel - the closest regulatory comparables to K923313.
VITEK RAPID CALL-GRAM NEGATIV IDENT CARD
K925915 · Biomerieux Vitek, Inc. · Mar 1993
SCEPTOR IDENTIFICATION SYSTEM
K912897 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED
K911429 · Vitek Systems, Inc. · Jun 1991
SENSITITRE AUTO ID PLATE AP80
K890057 · Radiometer America, Inc. · Jun 1989
GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL
K862642 · American Micro Scan · Sep 1986
PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM
K851528 · Pasco Laboratories, Inc. · Jul 1985