VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID
Device Facts
| Record ID | K022045 |
|---|---|
| Device Name | VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID |
| Applicant | bioMerieux, Inc. |
| Product Code | LON · Microbiology |
| Decision Date | Aug 15, 2002 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.1645 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.”
