MJA · Susceptibility Test Powders, Antimycobacterial
Microbiology · 21 CFR 866.1640 · Class 2
Overview
| Product Code | MJA |
|---|---|
| Device Name | Susceptibility Test Powders, Antimycobacterial |
| Regulation | 21 CFR 866.1640 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K052323 | VERSATREK MYCO PZA KIT | Trek Diagnostic Systems, Inc. | Jan 19, 2006 | SESE |
| K021582 | BACTEC MGIT 960 PZA KIT | Becton, Dickinson & CO | Jul 13, 2002 | SESE |
| K014123 | BACTEC MGIT 960 SIRE KITS | Becton, Dickinson & CO | Apr 19, 2002 | SESE |
| K003062 | BACTEC MGIT 960 SIR KITS | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jun 6, 2001 | SESE |
| K972772 | ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING | Trek Diagnostic Systems, Inc. | Jul 13, 1999 | SESE |
Top Applicants
- Becton, Dickinson & CO — 2 clearances
- Trek Diagnostic Systems, Inc. — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
