LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Microbiology · 21 CFR 866.1645 · Class 2
Overview
| Product Code | LON |
|---|---|
| Device Name | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Regulation | 21 CFR 866.1645 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.
Classification Rationale
Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”
Recent Cleared Devices (20 of 301)
Showing 20 most recent of 301 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | bioMerieux, Inc. | Apr 15, 2026 | SESE |
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | BIOMERIEUX | Mar 26, 2026 | SESE |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | bioMerieux, Inc. | Aug 21, 2025 | SESE |
| K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) | Becton, Dickinson and Company | Aug 8, 2025 | SESE |
| K250447 | BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) | Becton, Dickinson and Company | May 19, 2025 | SESE |
| K234012 | VITEK COMPACT PRO | bioMerieux, Inc. | Mar 14, 2025 | SESE |
| K250344 | BD Phoenix Automated Microbiology System | Becton, Dickinson and Company | Mar 6, 2025 | SESE |
| K233986 | BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL) | Becton, Dickinson and Company | Mar 15, 2024 | SESE |
| K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | bioMerieux, Inc. | Mar 11, 2024 | SESE |
| K232756 | Colibrí | Copan Wasp Srl | Dec 27, 2023 | SESE |
| K232201 | VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin | bioMerieux, Inc. | Oct 23, 2023 | SESE |
| K230864 | 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 | bioMerieux, Inc. | Jul 5, 2023 | SESE |
| K222378 | VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) | bioMerieux, Inc. | Jun 26, 2023 | SESE |
| K211748 | Selux AST System; Model AST Gen 1.0 | Selux Diagnostics, Inc. | Apr 19, 2023 | SESE |
| K222430 | VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin | Biomerieux Sa, Inc. | Mar 9, 2023 | SESE |
| K223478 | VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin | bioMerieux, Inc. | Feb 16, 2023 | SESE |
| K222073 | VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) | bioMerieux, Inc. | Feb 9, 2023 | SESE |
| K223481 | VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) | bioMerieux, Inc. | Feb 3, 2023 | SESE |
| K220803 | 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 | bioMerieux, Inc. | Jan 27, 2023 | SESE |
| K211759 | Selux AST System; Model AST Gen 1.0 | Selux Diagnostics, Inc. | Jan 18, 2023 | SESE |
Top Applicants
- bioMerieux, Inc. — 113 clearances
- Becton, Dickinson & CO — 106 clearances
- Dade Behring, Inc. — 37 clearances
- Becton, Dickinson and Company — 14 clearances
- Bd Diagnostic Systems — 3 clearances
