Not Cleared Post-NSE

DEN110001 - RIDASCREEN NOROVIRUS 3RD GENERATION EIA (FDA 510(k) Clearance)

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

DEN110001 · R-Biopharm AG · Microbiology device
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Feb 2011
Decision
7d
Days
Class 2
Risk

DEN110001 is an FDA 510(k) submission (not cleared) for the RIDASCREEN NOROVIRUS 3RD GENERATION EIA. Classified as Norovirus Serological Reagent (product code OUC), Class II - Special Controls.

Submitted by R-Biopharm AG (East Stroudsburg, US). The FDA issued a Not Cleared (DENG) decision on February 23, 2011 after a review of 7 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3395 - 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 R-Biopharm AG devices

Submission Details

510(k) Number DEN110001 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 16, 2011
Decision Date February 23, 2011
Days to Decision 7 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
95d faster than avg
Panel avg: 102d · This submission: 7d
Pathway characteristics

Device Classification

Product Code OUC Norovirus Serological Reagent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3395
Definition Norovirus Serological Reagents Are Devices That Consist Of Antigens And Antisera For The Detection Of Anti-norovirus Antibodies Or Norovirus Antigens. The Detection Aids In The Clinical Laboratory Diagnosis Of Norovirus Infection In Individuals With Signs And/or Symptoms Of Acute Gastroenteritis, Or In The Determining The Etiology Of Acute Gastroenteritis Outbreaks.
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.