Illumigene Pertusis DNA Amplification Assay, Illumigene Pertussis External Control Kit, ILLUMIPRO-10 Automated Isotherma
FDA 510(k) K133673 · Meridian Bioscience, Inc.
Submission
- Device name
- Illumigene Pertusis DNA Amplification Assay, Illumigene Pertussis External Control Kit, ILLUMIPRO-10 Automated Isotherma
- Applicant
- Meridian Bioscience, Inc.
Cincinnati, OH, US - Received
- November 29, 2013
- Decision date
- March 25, 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.
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|---|---|---|---|
| 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 |
| K143206 | AmpliVue Bordetella AssayOZZ · Traditional | Quidel Corporation | 12/10/2014SE |
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Questions and answers
When was Illumigene Pertusis DNA Amplification Assay, Illumigene Pertussis External Control Kit, ILLUMIPRO-10 Automated Isotherma cleared by the FDA?
Illumigene Pertusis DNA Amplification Assay, Illumigene Pertussis External Control Kit, ILLUMIPRO-10 Automated Isotherma (K133673) received a 510(k) decision of Substantially Equivalent on March 25, 2014, 116 days after the submission was received.
What is the product code of K133673?
The FDA product code is OZZ – Bordetella Pertussis Dna Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3980.