Cleared Traditional

K143302 - Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K143302 · Cepheid · Microbiology device
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Feb 2015
Decision
87d
Days
Class 2
Risk

K143302 is an FDA 510(k) clearance for the Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-.... Classified as System, Nucleic Acid-based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen (product code PEU), Class II - Special Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on February 12, 2015 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3373 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K143302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2014
Decision Date February 12, 2015
Days to Decision 87 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 102d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PEU System, Nucleic Acid-based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3373
Definition The [test] Is Intended For Use With Specimens From Patients For Whom There Is Clinical Suspicion Of Tuberculosis (tb) And Who Have Received No Antituberculosis Therapy, Or Less Than 3 Days Of Therapy. This [test] Is Intended As An Aid In The Diagnosis Of Pulmonary Tuberculosis When Used In Conjunction With Clinical And Other Laboratory Findings.
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.