Cleared Dual Track

K243753 - cobas liat Bordetella panel nucleic acid test (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Dual Track 510(k) pathway - typically does not require clinical trials.

K243753 · Roche Molecular Systems, Inc. · Microbiology device
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Nov 2025
Decision
350d
Days
Class 2
Risk

K243753 is an FDA 510(k) clearance for the cobas liat Bordetella panel nucleic acid test. Classified as Bordetella Pertussis Dna Assay System (product code OZZ), Class II - Special Controls.

Submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on November 20, 2025 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3980 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K243753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
248d slower than avg
Panel avg: 102d · This submission: 350d
Pathway characteristics

Device Classification

Product Code OZZ Bordetella Pertussis Dna Assay System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.