Verigene Gram-Positive Blood Culture (Gc-Gp) Nucleic Acid Test
FDA 510(k) K122514 · Nanosphere, Inc.
510(k) numberK122514
Submission
- Device name
- Verigene Gram-Positive Blood Culture (Gc-Gp) Nucleic Acid Test
- Applicant
- Nanosphere, Inc.
Northbrook, IL, US - Received
- August 17, 2012
- Decision date
- September 19, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PAM – Gram-Positive Bacteria And Their Resistance Markers
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3365
- Specialty
- Microbiology
A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.
Other 510(k)s with product code PAM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254194 | QIAstat-Dx BCID GPF Plus AMR PanelPAM · Traditional | QIAGEN GmbH | 08/06/2026SE |
| K243490 | LIAISON PLEX Gram-Positive Blood Culture AssayPAM · Traditional | Luminex Corporation | 06/06/2025SE |
| K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) PanelPAM · Traditional | Genmark Diagnostics, Incorporated | 12/20/2018SE |
| K163390 | iC-GPC Assay TM for use on the iC-SystemTMPAM · Traditional | Icubate, Inc. | 08/08/2017SE |
| K152470 | Great Basin Staph ID/R Blood Culture PanelPAM · Traditional | Great Basin Scientific, Inc. | 03/25/2016SE |
More from Great Basin Scientific, 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 |
| K132843 | Verigene Gram Negative Blood Culture Nucleic Acid Test (Bc-Gn)PEN · Traditional | 01/08/2014SE |
| 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 |
| 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-Positive Blood Culture (Gc-Gp) Nucleic Acid Test cleared by the FDA?
Verigene Gram-Positive Blood Culture (Gc-Gp) Nucleic Acid Test (K122514) received a 510(k) decision of Substantially Equivalent on September 19, 2012, 33 days after the submission was received.
What is the product code of K122514?
The FDA product code is PAM – Gram-Positive Bacteria And Their Resistance Markers, a Class II (moderate risk) device regulated under 21 CFR 866.3365.