Cleared Traditional

K212243 - VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)

K212243 is an FDA 510(k) clearance for VITEK 2 AST- Gram Positive Telavancin (..., 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 385-day FDA review.

K212243 · bioMerieux, Inc. · Microbiology device
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Aug 2022
Decision
385d
Days
Class 2
Risk

K212243 is an FDA 510(k) clearance for the VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL). 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 August 8, 2022 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K212243

510(k) Number K212243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2021
Decision Date August 08, 2022
Days to Decision 385 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
283d slower than avg
Panel avg: 102d · This submission: 385d
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 K212243.
Selux AST System
K211759 · Selux Diagnostics, Inc. · Jan 2023
VITEK 2 AST-Gram Positive Cefoxitin Screen
K220805 · bioMerieux, Inc. · Oct 2022
Colibrí System
K220546 · Copan Wasp Srl · Oct 2022
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