Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3365](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3365) → PEO — Fungal Organisms, Nucleic Acid-Based Assay

# PEO · Fungal Organisms, Nucleic Acid-Based Assay

_Microbiology · 21 CFR 866.3365 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PEO

## Overview

- **Product Code:** PEO
- **Device Name:** Fungal Organisms, Nucleic Acid-Based Assay
- **Regulation:** [21 CFR 866.3365](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3365)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

A multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures is a qualitative in vitro device intended to simultaneously detect and identify microorganism nucleic acids from blood cultures that test positive by Gram stain or other microbiological stains. The device detects specific nucleic acid sequences for microorganism identification as well as for antimicrobial resistance. This device aids in the diagnosis of bloodstream infections when used in conjunction with other clinical and laboratory findings. However, the device does not replace traditional methods for culture and susceptibility testing.

## Classification Rationale

Class II (special controls). The special control for this device is FDA's guideline document entitled “Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures.” For availability of the guideline document, see § 866.1(e).

## Special Controls

In combination with the general controls of the FD&C Act, the Verigene® Gram Positive Blood Culture Nucleic Acid Test is subject to the following special controls: The special controls for the BC-GP Assay are contained in the guideline document entitled "Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures."

*Classification.* Class II (special controls). The special control for this device is FDA's guideline document entitled “Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures.” For availability of the guideline document, see § 866.1(e).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K240627](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PEO/K240627.md) | LIAISON PLEX Yeast Blood Culture Assay | Luminex Corporation | Jun 4, 2024 | SESE |
| [K182690](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PEO/K182690.md) | ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel | Genmark Diagnostics, Incorporated | Dec 21, 2018 | SESE |

## Top Applicants

- Genmark Diagnostics, Incorporated — 1 clearance
- Luminex Corporation — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PEO](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PEO)

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