LIE · Reagent/Device, Inoculum Calibration
Microbiology · 21 CFR 866.1640 · Class 2
Overview
| Product Code | LIE |
|---|---|
| Device Name | Reagent/Device, Inoculum Calibration |
| Regulation | 21 CFR 866.1640 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K221493 | MicroScan Prompt Inoculation System-D | Beckman Coulter, Inc. | Apr 5, 2023 | SESE |
| K103456 | THE SENSITITRE AIM | Trek Diagnostic Systems | Jun 22, 2011 | SESE |
| K110331 | SENSITITRE AIM (TM) | Trek Diagnostic Systems, Ltd. | Apr 27, 2011 | SESE |
| K935566 | SENSI-CAL AMCO AEPA-1 | Radiometer America, Inc. | Mar 29, 1994 | SESE |
| K911059 | TURBIDOMETRIC STANDARD | Scientific Device Laboratory, Inc. | Jun 10, 1991 | SESE |
| K890339 | DIFCO DIRECTOR INOCULATION SYSTEM | Difco Laboratories, Inc. | Feb 7, 1989 | SESE |
| K820299 | PROMPT INOCULATION SYSTEM | 3M Company | Mar 15, 1982 | SESE |
Top Applicants
- 3M Company — 1 clearance
- Beckman Coulter, Inc. — 1 clearance
- Difco Laboratories, Inc. — 1 clearance
- Radiometer America, Inc. — 1 clearance
- Scientific Device Laboratory, Inc. — 1 clearance
