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510(k) K133673

ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA by Meridian Bioscience, Inc. — Product Code OZZ

K133673 is an FDA 510(k) premarket notification submitted by Meridian Bioscience, Inc. for the device "ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA". The FDA issued a decision of Substantially Equivalent on March 25, 2014. The device falls under product code OZZ (Bordetella Pertussis Dna Assay System), a Class II device regulated under 21 CFR 866.3980. Meridian Bioscience, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2014
Date Received
November 29, 2013
Clearance Type
Traditional
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 Meridian Bioscience, Inc.

  • K243922 — Revogene (March 20, 2025)
  • K230901 — Premier HpSA Flex (619096) (July 3, 2023)
  • K222829 — Curian® Shiga Toxin (April 17, 2023)
  • K222779 — Revogene (January 26, 2023)
  • K220480 — Revogene (July 11, 2022)
  • K210976 — Curian Campy (December 23, 2021)
  • K192817 — Curian HpSA, Curian Analyzer (March 13, 2020)
  • DEN180040 — Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit (November 30, 2018)
  • K182559 — PREMIER Platinum HpSA PLUS (November 5, 2018)
  • K163273 — TRU Legionella (February 21, 2017)

Other clearances for product code OZZ

  • K243753 — cobas liat Bordetella panel nucleic acid test (November 20, 2025)
  • K183223 — Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (December 19, 2018)
  • 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)

FDA data resources