Cleared Traditional

K080201 - VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE

K080201 is an FDA 510(k) clearance for VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAM..., manufactured by bioMerieux, Inc.. The device is a Class 2 Microbiology device with 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

FDA 510(k) Submission Details - K080201

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.

LON Device Classification - Class 2, Special Controls

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 283
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