Not Cleared Post-NSE

DEN030004 - WEST NILE VIRUS IGM CAPTURE ELISA (FDA 510(k) Clearance)

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

DEN030004 · Panbio Limited · Microbiology device
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Jul 2003
Decision
5d
Days
Class 2
Risk

DEN030004 is an FDA 510(k) submission (not cleared) for the WEST NILE VIRUS IGM CAPTURE ELISA. Classified as Elisa, Antibody, West Nile Virus (product code NOP), Class II - Special Controls.

Submitted by Panbio Limited (Windsor, AU). The FDA issued a Not Cleared (DENG) decision on July 8, 2003 after a review of 5 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3940 - 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.

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Submission Details

510(k) Number DEN030004 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 03, 2003
Decision Date July 08, 2003
Days to Decision 5 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
97d faster than avg
Panel avg: 102d · This submission: 5d
Pathway characteristics

Device Classification

Product Code NOP Elisa, Antibody, West Nile Virus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3940
Definition The West Nile Virus Elisa Is Intended For The Detection Of Igg And Igm Antibodies To West Nile Virus. Specimens May Be Serum Or Cerebral Spinal Fluid From Symptomatic Patients.
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.