Cleared Traditional

K020871 - VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY T...

K020871 is the FDA 510(k) clearance for VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY T... by bioMerieux, Inc.. It is a Class 2 Microbiology device (product code LON) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K020871 · bioMerieux, Inc. · Microbiology device
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Mar 2002
Decision
91d
Days
Class 2
Risk

K020871 is an FDA 510(k) clearance for the VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN. Classified as System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on March 29, 2002 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1645 - 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 bioMerieux, Inc. devices

Submission Details

510(k) Number K020871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2001
Decision Date March 29, 2002
Days to Decision 91 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 102d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1645
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 Microbiology devices follow this clearance model.

Regulatory Peers - LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

All 281
Devices cleared under the same product code (LON) and FDA review panel - the closest regulatory comparables to K020871.
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML)
K020319 · Dade Behring, Inc. · Apr 2002
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML)
K020506 · Dade Microscan, Inc. · Apr 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K020323 · Becton, Dickinson & CO · Apr 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K020322 · Becton, Dickinson & CO · Mar 2002
VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN
K020870 · bioMerieux, Inc. · Mar 2002
MICROSCAN SYNERGIES PLUS
K020142 · Dade Behring, Inc. · Mar 2002