510(k) · Cleared

Cleared

Spectral West Nile Virus Igm Status Test

K052519510(k) TraditionalCleared Nov 30, 2006442-day reviewClass II21 CFR 866.3940

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spectral Diagnostics, Inc. · NOP Elisa, Antibody, West Nile Virus

Cleared on Nov 30, 2006 as substantially equivalent to K031952 (Focus Technologies, Inc., 2003) after a 442-day review. Its family tree reaches back 2 generations to 2000.

Decided: Nov 30, 2006
Review: 442 days
Class: Class II
Product code: NOP
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K993724 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK993724 HSV-2 Elisa Igg, Model EL0920GMrl Diagnostics · 2000
1 generation backK031952 West Nile Virus Igm Capture Elisa, Model EL0300MFocus Technologies, Inc. · 2003
This deviceK052519 Spectral West Nile Virus Igm Status TestSpectral Diagnostics, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K993724	HSV-2 Elisa Igg, Model EL0920G	Mrl Diagnostics	2000	—
−1	K031952	West Nile Virus Igm Capture Elisa, Model EL0300M	Focus Technologies, Inc.	2003	—
0 (this device)	K052519	Spectral West Nile Virus Igm Status Test	Spectral Diagnostics, Inc.	2006	—

FIG. 1 — Lineage of K052519, 2000–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NOP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K031952	West Nile Virus Igm Capture Elisa, Model EL0300M Summary page 1 …21 CFR § 866.3940 Class 11 Predicate Device Focus West Nile Virus IgM Capture ELISA (K031952) Device Description A Simple and Rapid Immunoassay for the Qualitative Detection of West Nile Virus lgM Antibodies in Human Se…	Focus Technologies, Inc.	2003	—

Also cleared against K031952: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K031952.

How does its category compare?

All NOP devices

NOP Elisa, Antibody, West Nile Virus: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NOP

2in 2016

2007high 2 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NOP

Too few NOP 510(k)s in any year since 2007 to give a median.

Recalls per year · NOP

1in 2012

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NOP

1in 2019

2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code NOP, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	1
2008	0	—	1	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	1	0
2013	0	—	0	1
2014	0	—	0	1
2015	0	—	0	0
2016	2	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	1
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The Spectral West Nile virus IgM STATusTM test is a rapid immunochromatographic lateral flow assay that utilizes recombinant West Nile virus (WNV) antigen (E glycoprotein) for the qualitative detection of IgM antibodies to WNV in human serum or plasma (sodium heparin or sodium citrate). This test is for the presumptive laboratory diagnosis of West Nile virus infection in patients having signs and symptoms of meningoencephalitis. Positive results must be confirmed by the PRNT (Plaque Neutralization Reduction Test), or by using the current CDC guidelines for diagnosis of this disease. The Spectral test is not intended for point of care testing, home use or in screening blood donor samples.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052519 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052519: Spectral West Nile Virus Igm Status Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052519

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026