Not Cleared Post-NSE

DEN110001 - RIDASCREEN NOROVIRUS 3RD GENERATION EIA

DEN110001 is an FDA 510(k) submission for RIDASCREEN NOROVIRUS 3RD GENERATION EIA, manufactured by R-Biopharm AG. The device is a Class 2 Microbiology device with product code OUC cleared through the Post-NSE 510(k) pathway after a 7-day FDA review.

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.

FDA 510(k) Submission Details - DEN110001

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

OUC Device Classification - Class 2, Special Controls

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.

DEN110001 · RIDASCREEN NOROVIRUS 3RD GENERATION EIA
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