Cleared Traditional

K041068 - WEST NILE VIRUS IGG INDIRECT ELISA

K041068 is an FDA 510(k) clearance for WEST NILE VIRUS IGG INDIRECT ELISA, manufactured by Panbio Limited. The device is a Class 2 Microbiology device with product code NOP cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K041068 · Panbio Limited · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K041068

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
Combination Product No
PCCP Authorized No
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.

NOP Device Classification - Class 2, Special Controls

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.

Regulatory Peers - NOP Elisa, Antibody, West Nile Virus

All 9
Devices cleared under the same product code (NOP) and FDA review panel - the closest regulatory comparables to K041068.
EUROIMMUN Anti-West Nile Virus ELISA (IgG)
K153303 · Euroimmun Us, Inc. · Aug 2016
SPECTRAL WEST NILE VIRUS IGM STATUS TEST
K052519 · Spectral Diagnostics, Inc. · Nov 2006
WEST NILE DETECT IGM ELISA
K041817 · Inbios Intl., Inc. · Nov 2004
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M
K041231 · Panbio Limited · Aug 2004
WEST NILE VIRUS IGM CAPTURE ELISA
K040854 · Focus Technologies, Inc. · Jun 2004
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M
K031952 · Focus Technologies, Inc. · Oct 2003
K041068 · WEST NILE VIRUS IGG INDIRECT ELISA
Download PDF FDA Summary Panbio Limited