Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
FDA 510(k) K143653 · Nanosphere, Inc.
Submission
- Device name
- Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
- Applicant
- Nanosphere, Inc.
Northbrook, IL, US - Received
- December 23, 2014
- Decision date
- September 4, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCC – Respiratory Virus Panel Nucleic Acid Assay System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Specialty
- Microbiology
A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of…
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| K140083 | Verigene Enteric Pathogen Nucleic Acid Test ( Ep)PCH · Traditional | 06/20/2014SE |
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| 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 |
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Questions and answers
When was Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) cleared by the FDA?
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) (K143653) received a 510(k) decision of Substantially Equivalent on September 4, 2015, 255 days after the submission was received.
What is the product code of K143653?
The FDA product code is OCC – Respiratory Virus Panel Nucleic Acid Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3980.