Solana Bordetella Complete Assay
FDA 510(k) K181029 · Quidel Corporation
510(k) numberK181029
Submission
- Device name
- Solana Bordetella Complete Assay
- Applicant
- Quidel Corporation
Athens, OH, US - Received
- April 18, 2018
- Decision date
- July 15, 2018
- 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 |
| 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 |
| K143206 | AmpliVue Bordetella AssayOZZ · Traditional | Quidel Corporation | 12/10/2014SE |
| K133673 | Illumigene Pertusis DNA Amplification Assay, Illumigene Pertussis External Control Kit…OZZ · Traditional | Meridian Bioscience, Inc. | 03/25/2014SE |
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| K173691 | Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation PackLSR · Traditional | 02/28/2018SE |
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Questions and answers
When was Solana Bordetella Complete Assay cleared by the FDA?
Solana Bordetella Complete Assay (K181029) received a 510(k) decision of Substantially Equivalent on July 15, 2018, 88 days after the submission was received.
What is the product code of K181029?
The FDA product code is OZZ – Bordetella Pertussis Dna Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3980.