K173498 is an FDA 510(k) clearance for the Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack. This device is classified as a Bordetella Pertussis Dna Assay System (Class II - Special Controls, product code OZZ).
Submitted by Diasorin Molecular, LLC (Cypress, US). The FDA issued a Cleared decision on August 13, 2018, 273 days after receiving the submission on November 13, 2017.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3980. A Qualitative In Vitro Diagnostic Assay Intended To Detect Bordetella Pertussis Dna Extracted From Human Respiratory Specimens. Detection Of Bordetella Pertussis Dna Aids In The Diagnosis Of Bordetella Pertussis Respiratory Infection In Conjunction With Other Clinical And Laboratory Testing In Patients Exhibiting Signs And Symptoms Of Upper Respiratory Tract Infection..
| 510(k) Number | K173498 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2017 |
| Decision Date | August 13, 2018 |
| Days to Decision | 273 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | OZZ - Bordetella Pertussis Dna Assay System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3980 |
| Definition | A Qualitative In Vitro Diagnostic Assay Intended To Detect Bordetella Pertussis Dna Extracted From Human Respiratory Specimens. Detection Of Bordetella Pertussis Dna Aids In The Diagnosis Of Bordetella Pertussis Respiratory Infection In Conjunction With Other Clinical And Laboratory Testing In Patients Exhibiting Signs And Symptoms Of Upper Respiratory Tract Infection. |