Not Cleared Post-NSE

XPERT EV, MODEL GXEV-100N-10 (DEN070004) - FDA 510(k) Clearance

Also marketed or referenced as:
GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065

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

DEN070004 · Cepheid · Microbiology device
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Mar 2007
Decision
4d
Days
Class 2
Risk

DEN070004 is an FDA 510(k) submission (not cleared) for the XPERT EV, MODEL GXEV-100N-10. Classified as Assay, Enterovirus Nucleic Acid (product code OAI), Class II - Special Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Not Cleared (DENG) decision on March 16, 2007 after a review of 4 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3225 - 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 DEN070004 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 12, 2007
Decision Date March 16, 2007
Days to Decision 4 days
Submission Type Post-NSE
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 102d · This submission: 4d
Pathway characteristics

Device Classification

Product Code OAI Assay, Enterovirus Nucleic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3225
Definition Consists Of Primers, Probes, Enzymes And Controls For The Amplification And Detection Of Enterovirus Rna In Cerebrospinal Fluid (csf) From Individuals Who Have Signs And Symptoms Consistent With Meningitis Or Meningoencephalitis. The Detection Of Enterovirus Rna, In Conjunction With Other Laboratory Tests, Aids In The Clinical Laboratory Diagnosis Of Viral Meningitis Caused By Enterovirus.
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.