PAM · Gram-Positive Bacteria And Their Resistance Markers
Microbiology · 21 CFR 866.3365 · Class 2
Overview
| Product Code | PAM |
|---|---|
| Device Name | Gram-Positive Bacteria And Their 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).
Cleared Devices (6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243490 | LIAISON PLEX Gram-Positive Blood Culture Assay | Luminex Corporation | Jun 6, 2025 | SESE |
| K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel | Genmark Diagnostics, Incorporated | Dec 20, 2018 | SESE |
| K163390 | iC-GPC Assay TM for use on the iC-SystemTM | Icubate, Inc. | Aug 8, 2017 | SESE |
| K152470 | Great Basin Staph ID/R Blood Culture Panel | Great Basin Scientific, Inc. | Mar 25, 2016 | SESE |
| K122514 | VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST | Nanosphere, Inc. | Sep 19, 2012 | SESE |
| DEN120014 | VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) | Nanosphere, Inc. | Jun 26, 2012 | DENG |
Top Applicants
- Nanosphere, Inc. — 2 clearances
- Luminex Corporation — 1 clearance
- Icubate, Inc. — 1 clearance
- Great Basin Scientific, Inc. — 1 clearance
- Genmark Diagnostics, Incorporated — 1 clearance
