Verigene Staphylococcus Blood Culture Nucleic Acid Test (Bc-S)
FDA 510(k) K112424 · Nanosphere, Inc.
510(k) numberK112424
Submission
- Device name
- Verigene Staphylococcus Blood Culture Nucleic Acid Test (Bc-S)
- Applicant
- Nanosphere, Inc.
Northbrook, IL, US - Received
- August 23, 2011
- Decision date
- December 16, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQX – System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.
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More from Cepheid
| 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 |
| K122514 | Verigene Gram-Positive Blood Culture (Gc-Gp) Nucleic Acid TestPAM · Traditional | 09/19/2012SE |
| 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 Staphylococcus Blood Culture Nucleic Acid Test (Bc-S) cleared by the FDA?
Verigene Staphylococcus Blood Culture Nucleic Acid Test (Bc-S) (K112424) received a 510(k) decision of Substantially Equivalent on December 16, 2011, 115 days after the submission was received.
What is the product code of K112424?
The FDA product code is NQX – System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen, a Class II (moderate risk) device regulated under 21 CFR 866.1640.