K143206 is an FDA 510(k) clearance for the AmpliVue Bordetella Assay. This device is classified as a Bordetella Pertussis Dna Assay System (Class II - Special Controls, product code OZZ).
Submitted by Quidel Corporation (Athens, US). The FDA issued a Cleared decision on December 10, 2014, 33 days after receiving the submission on November 7, 2014.
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 | K143206 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2014 |
| Decision Date | December 10, 2014 |
| Days to Decision | 33 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. |