Cleared Traditional

SPECTRAL WEST NILE VIRUS IGM STATUS TEST

K052519 · Spectral Diagnostics, Inc. · Microbiology

Nov 2006

Decision

442d

Days

Class 2

Risk

About This 510(k) Submission

K052519 is an FDA 510(k) clearance for the SPECTRAL WEST NILE VIRUS IGM STATUS TEST, a Elisa, Antibody, West Nile Virus (Class II — Special Controls, product code NOP), submitted by Spectral Diagnostics, Inc. (Toronto, Ontario, CA). The FDA issued a Cleared decision on November 30, 2006, 442 days after receiving the submission on September 14, 2005. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3940.

Submission Details

510(k) Number	K052519 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	NOP — Elisa, Antibody, West Nile Virus
Device Class	Class II — 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.