Cleared Traditional

NUCLISENS EASYQ ENTEROVIRUS SYSTEM (K063261) - FDA 510(k) Clearance

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

K063261 · bioMerieux, Inc. · Microbiology device
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Jun 2008
Decision
602d
Days
Class 2
Risk

K063261 is an FDA 510(k) clearance for the NUCLISENS EASYQ ENTEROVIRUS SYSTEM. Classified as Assay, Enterovirus Nucleic Acid (product code OAI), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Durham, US). The FDA issued a Cleared decision on June 23, 2008 after a review of 602 days - an unusually long review period, suggesting complex equivalence evaluation.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all bioMerieux, Inc. devices

Submission Details

510(k) Number K063261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2006
Decision Date June 23, 2008
Days to Decision 602 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
500d slower than avg
Panel avg: 102d · This submission: 602d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.