Cleared Special

K212849 - VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)

K212849 is an FDA 510(k) clearance for VITEK 2 AST-Gram Positive Linezolid (<=..., manufactured by Biom?rieux, Inc.. The device is a Class 2 Microbiology device with product code LON cleared through the Special 510(k) pathway after a 150-day FDA review.

K212849 · Biom?rieux, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
150d
Days
Class 2
Risk

K212849 is an FDA 510(k) clearance for the VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL). Classified as System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON), Class II - Special Controls.

Submitted by Biom?rieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on February 4, 2022 after a review of 150 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K212849

510(k) Number K212849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2021
Decision Date February 04, 2022
Days to Decision 150 days
Submission Type Special
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
48d slower than avg
Panel avg: 102d · This submission: 150d
Pathway characteristics
Modification to existing cleared device.

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 289
Devices cleared under the same product code (LON) and FDA review panel - the closest regulatory comparables to K212849.
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
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K214023 · bioMerieux, Inc. · Apr 2022
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K213241 · bioMerieux, 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
VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)
K211630 · bioMerieux, Inc. · Aug 2021
K212849 · VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)
Download PDF FDA Summary Biom?rieux, Inc.