AmpliVue Bordetella Assay
FDA 510(k) K143206 · Quidel Corporation
510(k) numberK143206
Submission
- Device name
- AmpliVue Bordetella Assay
- Applicant
- Quidel Corporation
Athens, OH, US - Received
- November 7, 2014
- Decision date
- December 10, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OZZ – Bordetella Pertussis Dna Assay System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Specialty
- Microbiology
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.
Other 510(k)s with product code OZZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243753 | cobas liat Bordetella panel nucleic acid testOZZ · Dual Track | Roche Molecular Systems, Inc. | 11/20/2025SE |
| K183223 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackOZZ · Special | Diasorin Molecular, LLC | 12/19/2018SE |
| K173498 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackOZZ · Traditional | Diasorin Molecular, LLC | 08/13/2018SE |
| K181029 | Solana Bordetella Complete AssayOZZ · Traditional | Quidel Corporation | 07/15/2018SE |
| K163626 | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitOZZ · Traditional | Luminex Corporation | 05/02/2017SE |
| K170284 | Great Basin Bordetella Direct TestOZZ · Traditional | Great Basin Scientific, Inc. | 03/31/2017SE |
| K152285 | illumigene Pertussis DNA Amplification AssayOZZ · Traditional | Meridian Bioscience, Inc. | 11/10/2015SE |
| K133673 | Illumigene Pertusis DNA Amplification Assay, Illumigene Pertussis External Control Kit…OZZ · Traditional | Meridian Bioscience, Inc. | 03/25/2014SE |
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| K230349 | Lyra RSV+hMPV AssayOEM · Special | 03/10/2023SE |
| K230236 | Lyra Influenza A+B AssayOZE · Special | 03/03/2023SE |
| K211342 | Sofia 2 Campylobacter FIALQP · Traditional | 11/23/2021SE |
| K173496 | Sofia 2 Lyme FIA, Sofia Lyme Control SetLSR · Dual Track | 08/30/2018SE |
| K181029 | Solana Bordetella Complete AssayOZZ · Traditional | 07/15/2018SE |
| K173691 | Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation PackLSR · Traditional | 02/28/2018SE |
| K180288 | QuickVue Influenza A+BPSZ · Special | 02/13/2018SE |
Questions and answers
When was AmpliVue Bordetella Assay cleared by the FDA?
AmpliVue Bordetella Assay (K143206) received a 510(k) decision of Substantially Equivalent on December 10, 2014, 33 days after the submission was received.
What is the product code of K143206?
The FDA product code is OZZ – Bordetella Pertussis Dna Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3980.