Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
FDA 510(k) K173498 · Diasorin Molecular, LLC
510(k) numberK173498
Submission
- Device name
- Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
- Applicant
- Diasorin Molecular, LLC
Cypress, CA, US - Received
- November 13, 2017
- Decision date
- August 13, 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 |
| 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 |
| 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 |
|---|---|---|
| K260333 | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab KitPGX · Dual Track | 06/15/2026SE |
| K251978 | Liaison Nes Flu A/B, RSV & COVID-19QOF · Dual Track | 12/23/2025SE |
| K252387 | Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV…QOF · Traditional | 10/30/2025SE |
| K220963 | Simplexa COVID-19 & Flu A/B DirectQOF · Traditional | 03/17/2023SE |
| K202755 | Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control PackQDZ · Traditional | 11/05/2022SE |
| K212147 | Simplexa COVID-19 DirectQQX · Traditional | 09/13/2022SE |
| K201505 | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control PackOCC · Traditional | 08/22/2020SE |
| K192376 | Simplexa VZV Swab Direct, Simplexa VZV Positive Control PackPGI · Traditional | 11/26/2019SE |
| K190219 | Simplexa VZV Direct, Simplexa VZV Positive Control PackPLO · Traditional | 05/13/2019SE |
| K183223 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackOZZ · Special | 12/19/2018SE |
Questions and answers
When was Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack cleared by the FDA?
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (K173498) received a 510(k) decision of Substantially Equivalent on August 13, 2018, 273 days after the submission was received.
What is the product code of K173498?
The FDA product code is OZZ – Bordetella Pertussis Dna Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3980.