Cleared Traditional

K041068 - WEST NILE VIRUS IGG INDIRECT ELISA (FDA 510(k) Clearance)

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

K041068 · Panbio Limited · Microbiology device
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Oct 2004
Decision
177d
Days
Class 2
Risk

K041068 is an FDA 510(k) clearance for the WEST NILE VIRUS IGG INDIRECT ELISA. Classified as Elisa, Antibody, West Nile Virus (product code NOP), Class II - Special Controls.

Submitted by Panbio Limited (Windsor, AU). The FDA issued a Cleared decision on October 20, 2004 after a review of 177 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3940 - 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.

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Submission Details

510(k) Number K041068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2004
Decision Date October 20, 2004
Days to Decision 177 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
75d slower than avg
Panel avg: 102d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NOP Elisa, Antibody, West Nile Virus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3940
Definition The West Nile Virus Elisa Is Intended For The Detection Of Igg And Igm Antibodies To West Nile Virus. Specimens May Be Serum Or Cerebral Spinal Fluid From Symptomatic Patients.
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.