Verigene Gram Negative Blood Culture Nucleic Acid Test (Bc-Gn)
FDA 510(k) K132843 · Nanosphere, Inc.
510(k) numberK132843
Submission
- Device name
- Verigene Gram Negative Blood Culture Nucleic Acid Test (Bc-Gn)
- Applicant
- Nanosphere, Inc.
Northbrook, IL, US - Received
- September 10, 2013
- Decision date
- January 8, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PEN – Gram-Negative Bacteria And Associated Resistance Markers
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3365
- Specialty
- Microbiology
A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243013 | LIAISON PLEX Gram-Negative Blood Culture AssayPEN · Traditional | Luminex Corporation | 04/18/2025SE |
| K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack)…PEN · Special | Biofire Diagnostics, LLC | 12/20/2024SE |
| K213236 | ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelPEN · Traditional | Genmark Diagnostics, Incorporated | 04/27/2022SE |
| K193519 | BioFire Blood Culture Identification 2 (BCID2) PanelPEN · Traditional | Biofire Diagnostics, LLC | 03/18/2020SE |
| K190341 | iC-GN iC-Cassette for use on the iC-SystemPEN · Traditional | Icubate, Inc. | 06/28/2019SE |
| K182619 | ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelPEN · Traditional | Genmark Diagnostics, Incorporated | 04/12/2019SE |
| K181493 | FilmArray Blood Culture Identification (BCID) PanelPEN · Special | Biofire Diagnostics, LLC | 07/05/2018SE |
| K160457 | FilmArray Blood Culture Identification (BCID) panel for use with FilmArray TorchPEN · Special | Biofire Diagnostics, LLC | 03/15/2016SE |
| K143171 | FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0PEN · Traditional | Biofire Diagnostics, LLC | 01/30/2015SE |
| K130914 | Filmarray Blood Culture Identification (Bcid) PanelPEN · Traditional | Biofire Diagnostics, Inc. | 06/21/2013SE |
More from Biofire Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K143653 | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)OCC · Traditional | 09/04/2015SE |
| K140083 | Verigene Enteric Pathogen Nucleic Acid Test ( Ep)PCH · Traditional | 06/20/2014SE |
| K123197 | Verigene C. Difficile Nucleic Acid Test (CDF)OZN · Traditional | 12/05/2012SE |
| K120466 | Verigene CYP2C19 Nucleic Acid Tes (2C19)NTI · Traditional | 11/06/2012SE |
| K122514 | Verigene Gram-Positive Blood Culture (Gc-Gp) Nucleic Acid TestPAM · Traditional | 09/19/2012SE |
| K112424 | Verigene Staphylococcus Blood Culture Nucleic Acid Test (Bc-S)NQX · Traditional | 12/16/2011SE |
| K103209 | Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)OCC · Traditional | 01/10/2011SE |
| K093337 | Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP SystemOCC · Special | 11/17/2009SE |
| K092957 | Verigene System, Verigene Respiratory Virus Nucleic Acid TestOCC · Special | 10/21/2009SE |
| K092566 | Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System (Rvnatsp)OCC · Traditional | 10/09/2009SE |
Questions and answers
When was Verigene Gram Negative Blood Culture Nucleic Acid Test (Bc-Gn) cleared by the FDA?
Verigene Gram Negative Blood Culture Nucleic Acid Test (Bc-Gn) (K132843) received a 510(k) decision of Substantially Equivalent on January 8, 2014, 120 days after the submission was received.
What is the product code of K132843?
The FDA product code is PEN – Gram-Negative Bacteria And Associated Resistance Markers, a Class II (moderate risk) device regulated under 21 CFR 866.3365.