K152285 is an FDA 510(k) clearance for the illumigene Pertussis DNA Amplification Assay. This device is classified as a Bordetella Pertussis Dna Assay System (Class II - Special Controls, product code OZZ).
Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on November 10, 2015, 90 days after receiving the submission on August 12, 2015.
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 | K152285 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2015 |
| Decision Date | November 10, 2015 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| 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. |