OZZ — Bordetella Pertussis Dna Assay System Class II
FDA product code OZZ covers "Bordetella Pertussis Dna Assay System", a Class II medical device regulated under 21 CFR 866.3980. Submissions are reviewed by the Microbiology panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OZZ
- Device Class
- Class II
- Regulation Number
- 866.3980
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243753 | roche molecular systems | cobas liat Bordetella panel nucleic acid test | November 20, 2025 |
| K183223 | diasorin molecular | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | December 19, 2018 |
| K173498 | diasorin molecular | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | August 13, 2018 |
| K181029 | quidel corporation | Solana Bordetella Complete Assay | July 15, 2018 |
| K163626 | luminex corporation | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit | May 2, 2017 |
| K170284 | great basin scientific | Great Basin Bordetella Direct Test | March 31, 2017 |
| K152285 | meridian bioscience | illumigene Pertussis DNA Amplification Assay | November 10, 2015 |
| K143206 | quidel corporation | AmpliVue Bordetella Assay | December 10, 2014 |
| K133673 | meridian bioscience | ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTR | March 25, 2014 |