| Device |
susceptibility test discs, antimicrobial |
| Regulation Description |
Antimicrobial susceptibility test disc. |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | JTN |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.1620
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
Recognized Consensus Standards
- 7-243 CLSI M51-A (Replaces M51-P)
Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline - 7-262 CLSI M45 3rd Edition
Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria - 7-278 CLSI M27 4th Edition
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts - 7-280 CLSI M02 13th Edition
Performance Standards for Antimicrobial Disk Susceptibility Tests - 7-287 CLSI M44-S3 (2018)
Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement - 7-288 CLSI M24 3rd Edition
Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes - 7-292 CLSI M62 1st Edition
Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and other Aerobic Actinomycetes - 7-304 CLSI M23 5th Edition
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters - 7-312 CLSI M39 5th Edition
Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data - 7-314 CLSI M27M44S, 3rd Edition
Performance Standards for Antifungal Susceptibility Testing of Yeasts - 7-317 CLSI M100 33rd, Edition
Performance Standards for Antimicrobial Susceptibility Testing - 7-319 CLSI M23 6th Edition
Development of In Vitro Susceptibility Test Methods, Breakpoints, and Quality Control Parameters - 7-325 CLSI M02 14th Edition
Performance Standards for Antimicrobial Disk Susceptibility Tests - 7-326 CLSI M24S 2nd Edition
Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes - 7-327 CLSI M100 34th Edition
Performance Standards for Antimicrobial Susceptibility Testing
|
|
|
Third Party Review
|
Accredited Persons
|
|
|
