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510(k) K183223

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack by Diasorin Molecular, LLC — Product Code OZZ

K183223 is an FDA 510(k) premarket notification submitted by Diasorin Molecular, LLC for the device "Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack". The FDA issued a decision of Substantially Equivalent on December 19, 2018. The device falls under product code OZZ (Bordetella Pertussis Dna Assay System), a Class II device regulated under 21 CFR 866.3980. Diasorin Molecular, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2018
Date Received
November 20, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bordetella Pertussis Dna Assay System
Device Class
Class II
Regulation Number
866.3980
Review Panel
MI
Submission Type

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 clearances by Diasorin Molecular, LLC

  • K260333 — LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit (June 15, 2026)
  • K251978 — LIAISON NES FLU A/B, RSV & COVID-19 (December 23, 2025)
  • K252387 — Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B (October 30, 2025)
  • DEN230092 — Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. a (July 15, 2024)
  • K220963 — Simplexa COVID-19 & Flu A/B Direct (March 17, 2023)
  • K202755 — Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack (November 5, 2022)
  • K212147 — Simplexa COVID-19 Direct (September 13, 2022)
  • K201505 — Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pa (August 22, 2020)
  • K192376 — Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack (November 26, 2019)
  • K190219 — Simplexa VZV Direct, Simplexa VZV Positive Control Pack (May 13, 2019)

Other clearances for product code OZZ

  • K243753 — cobas liat Bordetella panel nucleic acid test (November 20, 2025)
  • K173498 — Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (August 13, 2018)
  • K181029 — Solana Bordetella Complete Assay (July 15, 2018)
  • K163626 — ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit (May 2, 2017)
  • K170284 — Great Basin Bordetella Direct Test (March 31, 2017)
  • K152285 — illumigene Pertussis DNA Amplification Assay (November 10, 2015)
  • K143206 — AmpliVue Bordetella Assay (December 10, 2014)
  • K133673 — ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTR (March 25, 2014)

FDA data resources