Cleared Dual Track

cobas liat Bordetella panel nucleic acid test

K243753 · Roche Molecular Systems, Inc. · Microbiology

Nov 2025

Decision

350d

Days

Class 2

Risk

About This 510(k) Submission

K243753 is an FDA 510(k) clearance for the cobas liat Bordetella panel nucleic acid test, a Bordetella Pertussis Dna Assay System (Class II — Special Controls, product code OZZ), submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on November 20, 2025, 350 days after receiving the submission on December 5, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K243753 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 2024
Decision Date	November 20, 2025
Days to Decision	350 days
Submission Type	Dual Track
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	OZZ — Bordetella Pertussis Dna Assay System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3980
Definition	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.