Part 866 Subpart B—Diagnostic Devices
FDA submissions for Part 866 Subpart B—Diagnostic Devices in the Microbiology (MI) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 866.1620–866.1700
CFR Part: 866
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | 866.1620 | 2 | 328 |
| LTX | Discs, Elution | 866.1620 | 2 | 2 |
| JTT | Susceptibility Test Powders, Antimicrobial | 866.1640 | 2 | 24 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 866.1640 | 2 | 441 |
| LIE | Reagent/Device, Inoculum Calibration | 866.1640 | 2 | 7 |
| LOP | Solution, Antimicrobial | 866.1640 | 2 | 3 |
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | 866.1640 | 2 | 45 |
| LTT | Panels, Test, Susceptibility, Antimicrobial | 866.1640 | 2 | 52 |
| LTW | Susceptibility Test Cards, Antimicrobial | 866.1640 | 2 | 17 |
| MJA | Susceptibility Test Powders, Antimycobacterial | 866.1640 | 2 | 5 |
| MYI | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies | 866.1640 | 2 | 10 |
| NGZ | Susceptibility Test Plate, Antifungal | 866.1640 | 2 | 21 |
| NIJ | System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species | 866.1640 | 2 | 6 |
| NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 866.1640 | 2 | 24 |
| PMY | System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony | 866.1640 | 2 | 3 |
| POC | System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen | 866.1640 | 2 | 3 |
| PTJ | Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates | 866.1640 | 2 | 3 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 866.1645 | 2 | 301 |
| PRH | Positive Blood Culture Identification And Ast Kit | 866.1650 | 2 | 2 |
| QZX | Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing | 866.1650 | 2 | 3 |
| SAN | Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples | 866.1650 | 2 | 6 |
| QIV | Culture-Based Short-Term Incubation Antimicrobial Resistance Assay | 866.1655 | 2 | 1 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 866.1700 | 2 | 40 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 866.1700 | 2 | 74 |
| LKA | Culture Media, Antimicrobial Susceptibility Test | 866.1700 | 2 | 5 |
| MJD | Culture Media, Antimycobacteria, Susceptibility Test | 866.1700 | 2 | 3 |
| MJE | Culture Media, Antifungal, Susceptibility Test | 866.1700 | 2 | 1 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K260696 | MTS Gepotidacin 0.016-256 µg/mL | Liofilchem s.r.l. | Apr 17, 2026 |
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | bioMerieux, Inc. | Apr 15, 2026 |
| K253573 | ASTar BC G- Kit | Q-Linea AB | Apr 15, 2026 |
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | BIOMERIEUX | Mar 26, 2026 |
| K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 | Thermo Fisher Scientific (Oxoid Ltd.) | Dec 5, 2025 |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics | Nov 20, 2025 |
| K251875 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | Affinity Biosensors, LLC | Oct 27, 2025 |
| K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | Liofilchem s.r.l. | Oct 2, 2025 |
| K252062 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL | Thermo Fisher Scientific | Sep 25, 2025 |
| K250575 | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL | Thermo Fisher Scientific | Sep 5, 2025 |
| K252014 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL | Thermo Fisher Scientific | Aug 28, 2025 |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | bioMerieux, Inc. | Aug 21, 2025 |
| K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) | Liofilchem s.r.l. | Aug 20, 2025 |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) | Beckman Coulter, Inc. | Aug 20, 2025 |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) | Beckman Coulter, Inc. | Aug 15, 2025 |
| K251879 | Sulopenem SPM 2 µg | Liofilchem | Aug 12, 2025 |
| K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) | Becton, Dickinson and Company | Aug 8, 2025 |
| K250084 | MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) | Beckman Coulter, Inc. | Jul 18, 2025 |
| K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL | Thermo Fisher Scientific | Jun 30, 2025 |
| K250956 | HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics | Jun 26, 2025 |
| K250885 | Ceftobiprole BPR 5 µg Disc | Liofilchem, Inc. | Jun 23, 2025 |
| K242843 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. | Thermo Fisher Scientific | Jun 20, 2025 |
| K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) | Biomérieux | Jun 12, 2025 |
| K250789 | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 | Thermo Fisher Scientific (Oxoid Ltd.) | Jun 12, 2025 |
| K243499 | NG-Test® CTX-M MULTI | Ng Biotech | Jun 4, 2025 |
| K242659 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL | Thermo Fisher Scientific | May 22, 2025 |
| K250447 | BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) | Becton, Dickinson and Company | May 19, 2025 |
| K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | Hardy Diagnostics | May 15, 2025 |
| K250274 | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) | Biomerieux S.A. | Apr 30, 2025 |
| K242658 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL | Thermo Fisher Scientific | Apr 15, 2025 |
| K244044 | PBC Separator with Selux AST System | Selux Diagnostics, Inc. | Mar 28, 2025 |
| K234012 | VITEK COMPACT PRO | bioMerieux, Inc. | Mar 14, 2025 |
| K250344 | BD Phoenix Automated Microbiology System | Becton, Dickinson and Company | Mar 6, 2025 |
| K243738 | The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL | Thermo Fisher Scientific | Feb 27, 2025 |
| K243201 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL | Thermo Fisher Scientific | Feb 10, 2025 |
| K242905 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL | Thermo Fisher Scientific | Feb 10, 2025 |
| K243202 | MTS Ceftobiprole 0.002-32 µg/mL | Liofilchem s.r.l. | Jan 30, 2025 |
| K243169 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL | Thermo Fisher Scientific | Dec 19, 2024 |
| K243625 | Xpert MRSA/SA SSTI | Cepheid® | Dec 18, 2024 |
| K242653 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL | Thermo Fisher Scientific | Dec 5, 2024 |
| K242657 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL | Thermo Fisher Scientific | Nov 26, 2024 |
| K243405 | Xpert vanA | Cepheid® | Nov 21, 2024 |
| K243070 | Xpert® SA Nasal Complete | Cepheid® | Oct 25, 2024 |
| K241324 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | Affinity Biosensors, LLC | Oct 23, 2024 |
| K242021 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml. | Thermo Fisher Scientific | Oct 9, 2024 |
| K241967 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml. | Thermo Fisher Scientific | Oct 1, 2024 |
| K241060 | HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics | Jul 18, 2024 |
| K230675 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | Specific Diagnostics, LLC | Jun 20, 2024 |
| K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) | bioMerieux, Inc. | Jun 12, 2024 |
| K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) | bioMerieux, Inc. | Jun 7, 2024 |
| K240445 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml. | Thermo Fisher Scientific | May 16, 2024 |
| K221688 | ASTar BC G- Kit and ASTar Instrument | Q-Linea AB | Apr 26, 2024 |
| K211815 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System | Affinity Biosensors | Apr 2, 2024 |
| K231806 | Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 | Oxoid Limited (Part of Thermo Fisher Scientific) | Mar 22, 2024 |
| K233986 | BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL) | Becton, Dickinson and Company | Mar 15, 2024 |
| K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | bioMerieux, Inc. | Mar 11, 2024 |
| K223493 | PBC Separator with Selux AST System | Selux Diagnostics, Inc. | Feb 15, 2024 |
| K231536 | eQUANT System | Avails Medical, Inc. | Feb 8, 2024 |
| K232756 | Colibrí | Copan Wasp Srl | Dec 27, 2023 |
| K232310 | Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml | Thermo Fisher Scientific | Oct 31, 2023 |
| 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 |
| K232276 | Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 | Oxoid Limited (Part of Thermo Fisher Scientific) | Oct 6, 2023 |
| K232395 | ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD | Biomérieux | Oct 5, 2023 |
| K231433 | The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL | Thermo Fisher Scientific | Aug 31, 2023 |
| K231988 | Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml | Thermo Fisher Scientific | Aug 30, 2023 |
| K231994 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL | Thermo Fisher Scientific | Aug 25, 2023 |
| K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) | Hardy Diagnostics | Jul 6, 2023 |
| 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 |
| K230935 | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae) | Thermo Fisher Scientific | Jun 30, 2023 |
| K222378 | VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) | bioMerieux, Inc. | Jun 26, 2023 |
| K230651 | BD BBL Sensi-Disc Lefamulin 20µg (LMU-20) | Becton, Dickinson and Company | Jun 7, 2023 |
| K230827 | HardyDisk AST Rezafungin 5µg (RZF5) | Hardy Diagnostics | Jun 1, 2023 |
| K230479 | ComASP Cefiderocol 0.008-128 | Liofilchem s.r.l. | May 18, 2023 |
| K211748 | Selux AST System; Model AST Gen 1.0 | Selux Diagnostics, Inc. | Apr 19, 2023 |
| K221493 | MicroScan Prompt Inoculation System-D | Beckman Coulter, Inc. | Apr 5, 2023 |
| K223844 | Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae) | Thermo Fisher Scientific | Mar 21, 2023 |
| K221198 | Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL | Thermo Fisher Scientific | Mar 10, 2023 |
| 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 |
| 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 |
| K222073 | VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) | bioMerieux, Inc. | Feb 9, 2023 |
| K223481 | VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) | bioMerieux, Inc. | Feb 3, 2023 |
| 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 |
| K221899 | The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml | Thermo Fisher Scientific | Jan 20, 2023 |
| K211759 | Selux AST System; Model AST Gen 1.0 | Selux Diagnostics, Inc. | Jan 18, 2023 |
| K221826 | BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) | Becton, Dickinson and Company | Dec 21, 2022 |
| K220805 | VITEK 2 AST-Gram Positive Cefoxitin Screen | bioMerieux, Inc. | Oct 13, 2022 |
| K220546 | Colibrí System | Copan Wasp Srl | Oct 5, 2022 |
| K203336 | Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 | Oxoid Limited (Part of Thermo Fisher Scientific) | Sep 15, 2022 |
| K212243 | VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL) | bioMerieux, Inc. | Aug 8, 2022 |
| K213899 | 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 | bioMerieux, Inc. | Jul 12, 2022 |
| K213931 | VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) | bioMerieux, Inc. | Jun 3, 2022 |
| K214023 | VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL) | bioMerieux, Inc. | Apr 14, 2022 |
| K213241 | 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 | bioMerieux, Inc. | Feb 25, 2022 |
| K212849 | VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL) | Biomérieux, Inc. | Feb 4, 2022 |
| K203741 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml | Thermo Fisher Scientific | Dec 20, 2021 |
| K211539 | Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL | Thermo Fisher Scientific | Dec 15, 2021 |
| K210757 | ETEST Fosfomycin (FO) (0.032-512 µg/mL) | Biomerieux S.A. | Nov 12, 2021 |
| K210287 | VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL) | bioMerieux, Inc. | Oct 28, 2021 |
| K210873 | Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 | Oxoid Limited (Part of Thermo Fisher Scientific) | Oct 27, 2021 |
| K211672 | MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL | Liofilchem s.r.l. | Oct 20, 2021 |
