Cleared Traditional

K080201 - VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAM...

K080201 is the FDA 510(k) clearance for VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAM... by bioMerieux, Inc.. It is a Class 2 Microbiology device (product code LON) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K080201 · bioMerieux, Inc. · Microbiology device
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Apr 2008
Decision
93d
Days
Class 2
Risk

K080201 is an FDA 510(k) clearance for the VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE. 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 April 30, 2008 after a review of 93 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 K080201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2008
Decision Date April 30, 2008
Days to Decision 93 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
9d faster than avg
Panel avg: 102d · This submission: 93d
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 K080201.
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K082852 · Becton, Dickinson & CO · Jan 2009
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K082913 · Becton, Dickinson & CO · Dec 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST
K082538 · Becton, Dickinson & CO · Nov 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS
K073589 · Becton, Dickinson & CO · Mar 2008
VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
K080107 · bioMerieux, Inc. · Feb 2008
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
K073406 · bioMerieux, Inc. · Jan 2008