Cleared Traditional

K083278 - AVC A/H5N1 FLU TEST

K083278 is an FDA 510(k) clearance for AVC A/H5N1 FLU TEST, manufactured by Arbor Vita Corportation. The device is a Class 2 Microbiology device with product code OMS cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K083278 · Arbor Vita Corportation · Microbiology device
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Apr 2009
Decision
152d
Days
Class 2
Risk

K083278 is an FDA 510(k) clearance for the AVC A/H5N1 FLU TEST. Classified as Novel Influenza A Virus, A/h5 Ns1 Protein (product code OMS), Class II - Special Controls.

Submitted by Arbor Vita Corportation (Sunnyvale, US). The FDA issued a Cleared decision on April 8, 2009 after a review of 152 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3332 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Arbor Vita Corportation devices

FDA 510(k) Submission Details - K083278

510(k) Number K083278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2008
Decision Date April 08, 2009
Days to Decision 152 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
50d slower than avg
Panel avg: 102d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OMS Device Classification - Class 2, Special Controls

Product Code OMS Novel Influenza A Virus, A/h5 Ns1 Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3332
Definition Novel Influenza A Virus Reagents Are Used To Directly Detect And Differentiate Novel Influenza A Virus Specific Nonstructural Protein 1 (ns1) In Human Respiratory Specimens Or Viral Cultures. Detection And Differentiation Of Specific Ns1 Protein Aids In The Diagnosis Of Influenza Caused By Novel Influenza A Viruses In Patients With Clinical And Epidemiological Risk Of Infection With These Viruses. They Also Aid In The Presumptive Identification Of Specific Novel Influenza A Viruses And Provide Epidemiological Information On Influenza.
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.