Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart B — Diagnostic Devices](/submissions/MI/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 866.1640](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/866.1640) → PMY — System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony

# PMY · System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony

_Microbiology · 21 CFR 866.1640 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/PMY

## Overview

- **Product Code:** PMY
- **Device Name:** System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
- **Regulation:** [21 CFR 866.1640](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/866.1640)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## 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 |
| --- | --- | --- | --- | --- |
| [K191288](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/PMY/K191288.md) | Acuitas AMR Gene Panel | Opgen, Inc. | Sep 30, 2021 | SESE |
| [K190275](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/PMY/K190275.md) | GenePOC Carba | Genepoc, Inc. | May 10, 2019 | SESE |
| [K152614](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/PMY/K152614.md) | Xpert Carba-R | Cepheid | Mar 7, 2016 | SESE |

## Top Applicants

- Cepheid — 1 clearance
- Genepoc, Inc. — 1 clearance
- Opgen, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/PMY](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/PMY)

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