Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart B — Diagnostic Devices](/submissions/MI/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 866.1645](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/866.1645) → LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation # LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation _Microbiology · 21 CFR 866.1645 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON ## Overview - **Product Code:** LON - **Device Name:** System, Test, Automated, Antimicrobial Susceptibility, Short Incubation - **Regulation:** [21 CFR 866.1645](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/866.1645) - **Device Class:** 2 - **Review Panel:** [Microbiology](/submissions/MI) ## 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](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K260282.md) | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | bioMerieux, Inc. | Apr 15, 2026 | SESE | | [K260281](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K260281.md) | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | BIOMERIEUX | Mar 26, 2026 | SESE | | [K251579](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K251579.md) | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | bioMerieux, Inc. | Aug 21, 2025 | SESE | | [K251713](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K251713.md) | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) | Becton, Dickinson and Company | Aug 8, 2025 | SESE | | [K250447](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K250447.md) | BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) | Becton, Dickinson and Company | May 19, 2025 | SESE | | [K234012](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K234012.md) | VITEK COMPACT PRO | bioMerieux, Inc. | Mar 14, 2025 | SESE | | [K250344](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K250344.md) | BD Phoenix™ Automated Microbiology System | Becton, Dickinson and Company | Mar 6, 2025 | SESE | | [K233986](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K233986.md) | BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) | Becton, Dickinson and Company | Mar 15, 2024 | SESE | | [K234000](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K234000.md) | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | bioMerieux, Inc. | Mar 11, 2024 | SESE | | [K232756](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K232756.md) | Colibrí | Copan Wasp Srl | Dec 27, 2023 | SESE | | [K232201](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K232201.md) | 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](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K230864.md) | 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](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K222378.md) | VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL) | bioMerieux, Inc. | Jun 26, 2023 | SESE | | [K211748](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K211748.md) | Selux AST System; Model AST Gen 1.0 | Selux Diagnostics, Inc. | Apr 19, 2023 | SESE | | [K222430](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K222430.md) | 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](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K223478.md) | 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](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K222073.md) | VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) | bioMerieux, Inc. | Feb 9, 2023 | SESE | | [K223481](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K223481.md) | VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) | bioMerieux, Inc. | Feb 3, 2023 | SESE | | [K220803](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K220803.md) | 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](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K211759.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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