Cleared Traditional

K082346 - VITEK 2 GRAM NEGATIVE DORIPENEM

K082346 is the FDA 510(k) clearance for VITEK 2 GRAM NEGATIVE DORIPENEM by bioMerieux, Inc.. It is a Class 2 Microbiology device (product code LON) cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K082346 · bioMerieux, Inc. · Microbiology device
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Mar 2009
Decision
213d
Days
Class 2
Risk

K082346 is an FDA 510(k) clearance for the VITEK 2 GRAM NEGATIVE DORIPENEM. 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 16, 2009 after a review of 213 days - an extended review cycle.

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 K082346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2008
Decision Date March 16, 2009
Days to Decision 213 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
111d slower than avg
Panel avg: 102d · This submission: 213d
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
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