Cleared Traditional

K260619 - VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)

K260619 is an FDA 510(k) clearance for VITEK 2 AST-Streptococcus Cefepime (<=0..., manufactured by Biom?rieux, Inc.. The device is a Class 2 Microbiology device with product code LON cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K260619 · Biom?rieux, Inc. · Microbiology device
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Sep 2026
Decision
215d
Days
Class 2
Risk

K260619 is an FDA 510(k) clearance for the VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 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 September 28, 2026 after a review of 215 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. 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 Biom?rieux, Inc. devices

FDA 510(k) Submission Details - K260619

510(k) Number K260619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2026
Decision Date September 28, 2026
Days to Decision 215 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 102d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

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 285
Devices cleared under the same product code (LON) and FDA review panel - the closest regulatory comparables to K260619.
VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)
K260283 · bioMerieux, Inc. · Oct 2026
VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance
K260282 · bioMerieux, Inc. · Apr 2026
VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
K260281 · BIOMERIEUX · Mar 2026
VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
K251579 · bioMerieux, Inc. · Aug 2025
BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
K251713 · Becton, Dickinson and Company · Aug 2025
BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)
K250447 · Becton, Dickinson and Company · May 2025