510(k) K243753

cobas liat Bordetella panel nucleic acid test by Roche Molecular Systems, Inc. — Product Code OZZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 20, 2025
Date Received: December 5, 2024
Clearance Type: Dual Track
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.

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K240217 — cobas® liat CT/NG nucleic acid test (January 17, 2025)
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Other clearances for product code OZZ

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)
K133673 — ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTR (March 25, 2014)