Cleared Traditional

WEST NILE VIRUS IGM CAPTURE ELISA

K040854 · Focus Technologies, Inc. · Microbiology

Jun 2004

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K040854 is an FDA 510(k) clearance for the WEST NILE VIRUS IGM CAPTURE ELISA, a Elisa, Antibody, West Nile Virus (Class II — Special Controls, product code NOP), submitted by Focus Technologies, Inc. (Cypress, US). The FDA issued a Cleared decision on June 30, 2004, 90 days after receiving the submission on April 1, 2004. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3940.

Submission Details

510(k) Number	K040854 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 2004
Decision Date	June 30, 2004
Days to Decision	90 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.