Cleared Traditional

K213241 - VITEK 2 AST-Yeast Fluconazole (<=0.5->=...

K213241 is the FDA 510(k) clearance for VITEK 2 AST-Yeast Fluconazole (<=0.5->=... by bioMerieux, Inc.. It is a Class 2 Microbiology device (product code LON) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K213241 · bioMerieux, Inc. · Microbiology device
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Feb 2022
Decision
148d
Days
Class 2
Risk

K213241 is an FDA 510(k) clearance for the VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole .... 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 February 25, 2022 after a review of 148 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 K213241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2021
Decision Date February 25, 2022
Days to Decision 148 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
46d slower than avg
Panel avg: 102d · This submission: 148d
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 K213241.
VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin
K213899 · bioMerieux, Inc. · Jul 2022
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
K213931 · bioMerieux, Inc. · Jun 2022
VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)
K214023 · bioMerieux, Inc. · Apr 2022
VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)
K212849 · Biom?rieux, Inc. · Feb 2022
VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
K210287 · bioMerieux, Inc. · Oct 2021
VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)
K202396 · bioMerieux, Inc. · Sep 2021