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510(k) K163626

ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit by Luminex Corporation — Product Code OZZ

K163626 is an FDA 510(k) premarket notification submitted by Luminex Corporation for the device "ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit". The FDA issued a decision of Substantially Equivalent on May 2, 2017. The device falls under product code OZZ (Bordetella Pertussis Dna Assay System), a Class II device regulated under 21 CFR 866.3980. Luminex Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2017
Date Received
December 22, 2016
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 Luminex Corporation

  • K253722 — LIAISON PLEX Gastrointestinal Flex Assay (May 19, 2026)
  • K243490 — LIAISON PLEX Gram-Positive Blood Culture Assay (June 6, 2025)
  • K243013 — LIAISON PLEX Gram-Negative Blood Culture Assay (April 18, 2025)
  • K240627 — LIAISON PLEX Yeast Blood Culture Assay (June 4, 2024)
  • K233410 — LIAISON PLEX Respiratory Flex Assay (March 1, 2024)
  • K191742 — ARIES MRSA Assay (September 25, 2019)
  • K172402 — ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit (October 30, 2017)
  • K171441 — ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Ki (July 21, 2017)
  • K162772 — ARIES GBS Assay (December 23, 2016)
  • K161220 — ARIES® Flu A/B & RSV Assay (August 2, 2016)

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)
  • 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