Bordetella Pertussis Dna Assay System
The Bordetella Pertussis DNA Assay System is a qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens, aiding in the diagnosis of Bordetella pertussis (whooping cough) respiratory infection in conjunction with other clinical and laboratory testing in patients with signs and symptoms of upper respiratory tract infection. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OZZ, with regulation number 866.3980 under the Microbiology medical specialty.
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Basic Information
- Product Code
- OZZ
- Device Class
- FDA class 2
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243753 | cobas liat Bordetella panel nucleic acid test | Nov 20, 2025 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K183223 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | Dec 19, 2018 | Substantially Equivalent | Diasorin Molecular, LLC |
| K173498 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | Aug 13, 2018 | Substantially Equivalent | Diasorin Molecular, LLC |
| K181029 | Solana Bordetella Complete Assay | Jul 15, 2018 | Substantially Equivalent | Quidel Corporation |
| K163626 | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit | May 02, 2017 | Substantially Equivalent | Luminex Corporation |
| K170284 | Great Basin Bordetella Direct Test | Mar 31, 2017 | Substantially Equivalent | Great Basin Scientific, Inc. |
| K152285 | illumigene Pertussis DNA Amplification Assay | Nov 10, 2015 | Substantially Equivalent | Meridian Bioscience, Inc. |
| K143206 | AmpliVue Bordetella Assay | Dec 10, 2014 | Substantially Equivalent | Quidel Corporation |
| K133673 | ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA | Mar 25, 2014 | Substantially Equivalent | Meridian Bioscience, Inc. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.