Cleared Traditional

WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M (K031952) - FDA 510(k) Clearance

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

K031952 · Focus Technologies, Inc. · Microbiology device
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Oct 2003
Decision
119d
Days
Class 2
Risk

K031952 is an FDA 510(k) clearance for the WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M. Classified as Elisa, Antibody, West Nile Virus (product code NOP), Class II - Special Controls.

Submitted by Focus Technologies, Inc. (Cypress, US). The FDA issued a Cleared decision on October 22, 2003 after a review of 119 days - within the typical 510(k) review window.

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.

View all Focus Technologies, Inc. devices

Submission Details

510(k) Number K031952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2003
Decision Date October 22, 2003
Days to Decision 119 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
17d slower than avg
Panel avg: 102d · This submission: 119d
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.