Cleared Traditional

K052519 - SPECTRAL WEST NILE VIRUS IGM STATUS TEST (FDA 510(k) Clearance)

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

K052519 · Spectral Diagnostics, Inc. · Microbiology device
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Nov 2006
Decision
442d
Days
Class 2
Risk

K052519 is an FDA 510(k) clearance for the SPECTRAL WEST NILE VIRUS IGM STATUS TEST. Classified as Elisa, Antibody, West Nile Virus (product code NOP), Class II - Special Controls.

Submitted by Spectral Diagnostics, Inc. (Toronto, Ontario, CA). The FDA issued a Cleared decision on November 30, 2006 after a review of 442 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Spectral Diagnostics, Inc. devices

Submission Details

510(k) Number K052519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2005
Decision Date November 30, 2006
Days to Decision 442 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
340d slower than avg
Panel avg: 102d · This submission: 442d
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.