POC · System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
Microbiology · 21 CFR 866.1640 · Class 2
Overview
| Product Code | POC |
|---|---|
| Device Name | System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen |
| 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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K190613 | BD MAX Check-Points CPO | Check-Points Health B.V. | Aug 29, 2019 | SESE |
| K173263 | Xpert Carba-R | Cepheid | Jan 9, 2018 | SESE |
| K160901 | Xpert Carba-R | Cepheid | Jun 29, 2016 | SESE |
Top Applicants
- Cepheid — 2 clearances
- Check-Points Health B.V. — 1 clearance
