K190219 is an FDA 510(k) clearance for the Simplexa VZV Direct, Simplexa VZV Positive Control Pack. This device is classified as a Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System (Class II - Special Controls, product code PLO).
Submitted by Diasorin Molecular, LLC (Cypress, US). The FDA issued a Cleared decision on May 13, 2019, 98 days after receiving the submission on February 4, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3970. A Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System Is A Qualitative In Vitro Diagnostic Test For The Direct Detection And Identification Of Microbial-associated Nucleic Acids In Cerebrospinal Fluid. The Test Is Indicated For Individuals With Signs And Symptoms Of Meningitis Or Encephalitis And Aids In Diagnosis Of Agents Of Meningitis Or Encephalitis When Used In Conjunction With Clinical And Other Laboratory Findings..
| 510(k) Number | K190219 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2019 |
| Decision Date | May 13, 2019 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PLO - Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3970 |
| Definition | A Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System Is A Qualitative In Vitro Diagnostic Test For The Direct Detection And Identification Of Microbial-associated Nucleic Acids In Cerebrospinal Fluid. The Test Is Indicated For Individuals With Signs And Symptoms Of Meningitis Or Encephalitis And Aids In Diagnosis Of Agents Of Meningitis Or Encephalitis When Used In Conjunction With Clinical And Other Laboratory Findings. |