ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
FDA 510(k) K163626 · Luminex Corporation
510(k) numberK163626
Submission
- Device name
- ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
- Applicant
- Luminex Corporation
Austin, TX, US - Received
- December 22, 2016
- Decision date
- May 2, 2017
- 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 |
| 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 |
More from Meridian Bioscience, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253722 | LIAISON PLEX Gastrointestinal Flex AssayPCH · Traditional | 05/19/2026SE |
| K243490 | LIAISON PLEX Gram-Positive Blood Culture AssayPAM · Traditional | 06/06/2025SE |
| K243013 | LIAISON PLEX Gram-Negative Blood Culture AssayPEN · Traditional | 04/18/2025SE |
| K240627 | LIAISON PLEX Yeast Blood Culture AssayPEO · Traditional | 06/04/2024SE |
| K233410 | LIAISON PLEX Respiratory Flex AssayQOF · Traditional | 03/01/2024SE |
| K191742 | ARIES MRSA AssayNQX · Traditional | 09/25/2019SE |
| K172402 | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitPGX · Traditional | 10/30/2017SE |
| K171441 | ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES…OZN · Traditional | 07/21/2017SE |
| K162772 | ARIES GBS AssayNJR · Traditional | 12/23/2016SE |
| K161220 | ARIES® Flu A/B & RSV AssayOCC · Traditional | 08/02/2016SE |
Questions and answers
When was ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit cleared by the FDA?
ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit (K163626) received a 510(k) decision of Substantially Equivalent on May 2, 2017, 131 days after the submission was received.
What is the product code of K163626?
The FDA product code is OZZ – Bordetella Pertussis Dna Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3980.