Cleared Traditional

K171511 - RIDA GENE Norovirus GI/GII (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171511 · R-Biopharm AG · Microbiology device
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Aug 2017
Decision
89d
Days
Class 2
Risk

K171511 is an FDA 510(k) clearance for the RIDA GENE Norovirus GI/GII. Classified as Reagents For Detection Of Norovirus Nucleic Acid (product code PIQ), Class II - Special Controls.

Submitted by R-Biopharm AG (Darmstadt, DE). The FDA issued a Cleared decision on August 21, 2017 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3990 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all R-Biopharm AG devices

Submission Details

510(k) Number K171511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2017
Decision Date August 21, 2017
Days to Decision 89 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 102d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PIQ Reagents For Detection Of Norovirus Nucleic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3990
Definition Qualitative In Vitro Diagnostic Test For The Rapid Detection And Differentiation Of Norovirus Genogroup I And Genogroup Ii From Specimens E.g., Stool Collected From Individuals With Symptoms Of Acute Gastroenteritis.
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.