LON · Class II · 21 CFR 866.1645

FDA Product Code LON: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Under FDA product code LON, automated antimicrobial susceptibility testing systems are cleared for use in clinical microbiology laboratories.

Unlike manual methods, LON systems automatically inoculate, incubate, and read antimicrobial susceptibility panels, delivering results in hours rather than days. They are essential in high-volume laboratories requiring rapid, standardized antibiotic susceptibility data.

LON devices are Class II medical devices, regulated under 21 CFR 866.1645 and reviewed by the FDA Microbiology panel.

Leading manufacturers include bioMerieux, Inc. and Becton, Dickinson and Company.

Total

Cleared

181d

Avg days

2021

Since

List of System, Test, Automated, Antimicrobial Susceptibility, Short Incubation devices cleared through 510(k)

25 devices

1–24 of 25

Cleared Aug 21, 2025

VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)

BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)

K251713

Becton, Dickinson and Company

Microbiology · 66d

Cleared May 19, 2025

BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)

K250447

Becton, Dickinson and Company

BD Phoenix™ Automated Microbiology System

K250344

Becton, Dickinson and Company

Microbiology · 28d

Cleared Mar 15, 2024

BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)

K233986

Becton, Dickinson and Company

Microbiology · 88d

Cleared Mar 11, 2024

VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)

VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin

VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin

VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL)

VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL)

VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)

VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)

VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin

VITEK 2 AST-Gram Positive Cefoxitin Screen

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

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

VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)

VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)

VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole

VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)

VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)

VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)

VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)

K201675

bioMerieux, Inc.

Microbiology · 385d

How to use this database

This page lists all FDA 510(k) submissions for System, Test, Automated, Antimicrobial Susceptibility, Short Incubation devices (product code LON). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →

Data Source

FDA 510(k) public files . 4,872 total devices indexed.

Latest clearance: Aug 21, 2025

Product Code Info

Code	LON
Device class	Class II
CFR	21 CFR 866.1645
Panel	Microbiology

Verify on FDA.gov

View LON classification on FDA.gov →