FDA 510K for Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System
The Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System (AST System) is an in vitro diagnostic device used to determine the susceptibility of microorganisms to various antimicrobial agents. This system is designed to automate and shorten the incubation cycle typically required for traditional AST methods, improving the efficiency of susceptibility testing in clinical laboratories.
Intended Use of Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System
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.
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System
FDA 510K for Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Device Code and Regulation Number
| S.
No. |
Product Code | Device | Regulation
Description |
Regulation
Number |
Device Class |
| 1 | LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System | 866.1645 | 2 |
Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System
Intended Use:
It is intended for in vitro rapid identification (ID) and quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) for Gram-negative aerobic and facultative anaerobic bacteria, including both Enterobacterales and non-Enterobacterales species.
Device Description:
The System uses a broth-based microdilution method with a redox indicator (colorimetric oxidation-reduction) to enhance the detection of organism growth. The minimal inhibitory concentration (MIC) is determined by comparing growth in wells containing serial two-fold dilutions of an antibiotic to growth in “growth control wells” that contain no antibiotic. The system uses a redox indicator to detect organism growth, which is measured through color changes due to microbial activity in the presence of an antimicrobial agent. Results, including minimal inhibitory concentration (MIC) and susceptibility categories (susceptible, intermediate, resistant), are auto-read by the System, with AST results available within 16 hours.
Performance Testing (Analytical) for Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System
- Precision (Reproducibility and Repeatability)
- Traceability, Stability, Expected Values (Controls, Calibrators, or Methods)
- Comparison studies
- Expected Values/Reference Range
- Software Verification and Validation Testing
- Usability validation
Clinical Testing:
No Guidance available for 510k submission