PEN · Gram-Negative Bacteria And Associated Resistance Markers
Microbiology · 21 CFR 866.3365 · Class 2
Overview
| Product Code | PEN |
|---|---|
| Device Name | Gram-Negative Bacteria And Associated Resistance Markers |
| Regulation | 21 CFR 866.3365 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
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 (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243013 | LIAISON PLEX Gram-Negative Blood Culture Assay | Luminex Corporation | Apr 18, 2025 | SESE |
| K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) | Biofire Diagnostics, LLC | Dec 20, 2024 | SESE |
| K213236 | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | Genmark Diagnostics, Incorporated | Apr 27, 2022 | SESE |
| K193519 | BioFire Blood Culture Identification 2 (BCID2) Panel | Biofire Diagnostics, LLC | Mar 18, 2020 | SESE |
| K190341 | iC-GN iC-Cassette for use on the iC-System | Icubate, Inc. | Jun 28, 2019 | SESE |
| K182619 | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | Genmark Diagnostics, Incorporated | Apr 12, 2019 | SESE |
| K181493 | FilmArray Blood Culture Identification (BCID) Panel | Biofire Diagnostics, LLC | Jul 5, 2018 | SESE |
| K160457 | FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch | Biofire Diagnostics, LLC | Mar 15, 2016 | SESE |
| K143171 | FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 | Biofire Diagnostics, LLC | Jan 30, 2015 | SESE |
| K132843 | VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) | Nanosphere, Inc. | Jan 8, 2014 | SESE |
| K130914 | FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL | Biofire Diagnostics, Inc. | Jun 21, 2013 | SESE |
Top Applicants
- Biofire Diagnostics, LLC — 5 clearances
- Genmark Diagnostics, Incorporated — 2 clearances
- Nanosphere, Inc. — 1 clearance
- Luminex Corporation — 1 clearance
- Icubate, Inc. — 1 clearance
