JTN · Susceptibility Test Discs, Antimicrobial
Microbiology · 21 CFR 866.1620 · Class 2
Overview
| Product Code | JTN |
|---|---|
| Device Name | Susceptibility Test Discs, Antimicrobial |
| Regulation | 21 CFR 866.1620 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 328)
Showing 20 most recent of 328 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 | Thermo Fisher Scientific (Oxoid Ltd.) | Dec 5, 2025 | SESE |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics | Nov 20, 2025 | SESE |
| K251879 | Sulopenem SPM 2 µg | Liofilchem | Aug 12, 2025 | SESE |
| K250956 | HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics | Jun 26, 2025 | SESE |
| K250885 | Ceftobiprole BPR 5 µg Disc | Liofilchem, Inc. | Jun 23, 2025 | SESE |
| K250789 | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 | Thermo Fisher Scientific (Oxoid Ltd.) | Jun 12, 2025 | SESE |
| K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | Hardy Diagnostics | May 15, 2025 | SESE |
| K241060 | HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics | Jul 18, 2024 | SESE |
| K231806 | Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 | Oxoid Limited (Part of Thermo Fisher Scientific) | Mar 22, 2024 | SESE |
| K232276 | Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 | Oxoid Limited (Part of Thermo Fisher Scientific) | Oct 6, 2023 | SESE |
| K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) | Hardy Diagnostics | Jul 6, 2023 | SESE |
| K230651 | BD BBL Sensi-Disc Lefamulin 20µg (LMU-20) | Becton, Dickinson and Company | Jun 7, 2023 | SESE |
| K230827 | HardyDisk AST Rezafungin 5µg (RZF5) | Hardy Diagnostics | Jun 1, 2023 | SESE |
| K221826 | BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) | Becton, Dickinson and Company | Dec 21, 2022 | SESE |
| K203336 | Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 | Oxoid Limited (Part of Thermo Fisher Scientific) | Sep 15, 2022 | SESE |
| K210873 | Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 | Oxoid Limited (Part of Thermo Fisher Scientific) | Oct 27, 2021 | SESE |
| K203700 | Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 | Oxoid Limited (Part of Thermo Fisher Scientific) | Jul 30, 2021 | SESE |
| K193508 | Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 | Oxoid Limited (Part of Thermo Fisher Scientific) | Dec 4, 2020 | SESE |
| K193504 | HardyDisk AST Cefiderocol 30ug (FDC30) | Hardy Diagnostics | Jan 23, 2020 | SESE |
| K192326 | HardyDisk AST Lefamulin 20µg (LMU20) | Hardy Diagnostics | Sep 19, 2019 | SESE |
Top Applicants
- Hardy Diagnostics — 82 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 43 clearances
- Difco Laboratories, Inc. — 41 clearances
- Oxoid , Ltd. — 31 clearances
- Investigacion Farmaceutica S.A. DE C.V. — 19 clearances
