Not Cleared Direct

DEN240016 - Xpert HCV (FDA 510(k) Clearance)

Also includes:
GeneXpert Xpress System

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

DEN240016 · Cepheid · Microbiology device
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Jun 2024
Decision
72d
Days
Class 2
Risk

DEN240016 is an FDA 510(k) submission (not cleared) for the Xpert HCV. Classified as Simple Point-of-care Nucleic Acid-based Hepatitis C Virus Ribonucleic Acid Test (product code SBP), Class II - Special Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Not Cleared (DENG) decision on June 27, 2024 after a review of 72 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3171 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

View all Cepheid devices

Submission Details

510(k) Number DEN240016 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 16, 2024
Decision Date June 27, 2024
Days to Decision 72 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 102d · This submission: 72d
Pathway characteristics

Device Classification

Product Code SBP Simple Point-of-care Nucleic Acid-based Hepatitis C Virus Ribonucleic Acid Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3171
Definition A Simple Point-of-care Nucleic Acid-based Hepatitis C Virus (hcv) Ribonucleic Acid (rna) Test Is An In Vitro Diagnostic Device That Is Intended For Prescription Use For The Detection Of Hcv Rna In Clinical Specimens As An Aid In The Diagnosis Of Hcv Infection Or As An Aid In The Management Of Hcv-infected Patients, Including Individuals Without Antibodies To Hcv. This Device Is Simple To Use And Does Not Involve Sample Manipulation, Transportation Of The Sample To Another Functional Area (e.g., A Central Laboratory Or Other Specialized Area), Or Measurement Of Reagents Or Analytes That Could Be Affected By Conditions Such As Sample Turbidity Or Cell Lysis. The Test Is Not Intended For Use As A Donor Screening Test For The Presence Of Hcv Rna In Blood, Blood Products, Or Tissue Donors.
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.