The PANBIO West Nile Virus IgM Capture ELISA is for the qualitative presumptive detection of IoM antibodies to West Nile virus in serum as an aid in the clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with encephalitis / meningitis. Positive results must be confirmed by plaque reduction neutralization test (PRNT), or by using the current Centers for Disease Control and Prevention (CDC) guidelines for diagnosis of this disease.

Assay performance characteristics have not been established for testing cord blood, neonate, prenatal screening, general population screening without symptoms of meningioencephalitis or automated instruments. The user is responsible for establishing these assay performance characteristics.

Caution: Cross-reactivity has been noted with the PANBIO West Nile IgM assay in specimens containing rheumatoid factor (RF). Reactive results must be reported with a caution statement regarding possible cross-reactivity with RF.

Device Description

The West Nile Virus IgM Capture ELISA is an Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of IgM antibodies to West Nile virus in serum as an aid in the clinical laboratory diagnosis of West Nile virus in patients with clinical symptoms consistent with encephalitis / meningitis.

AI/ML Overview

Acceptance Criteria and Device Performance Study for PANBIO West Nile Virus IgM Capture ELISA

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve at least X% sensitivity and Y% specificity"). However, the performance characteristics obtained serve as the benchmark for clearance. Given the context of a 510(k) summary, the "reported device performance" essentially functions as the de facto acceptance criteria, demonstrating substantial equivalence to the predicate device.

Performance Metric	Acceptance Criteria (Implied by Study Outcomes)	Reported Device Performance (95% CI)
Study Site 1 (PRNT-Confirmed)
Serological Sensitivity	High, to detect true WNV positive cases	96.7% (88.7 – 99.6%)
Serological Specificity	High, to correctly identify WNV negative cases	85.5% (75.0 - 92.8%)
Study Site 1 (CDC MAC EIA Presumptive)
Positive Agreement	High, to agree with CDC MAC EIA positive results	100% (71.5 – 100%)
Negative Agreement	High, to agree with CDC MAC EIA negative results	98.4% (91.3 – 100%)
Study Site 1 (IgM IFA Presumptive)
Positive Agreement¹	High, to agree with IgM IFA positive results (worst-case scenario)	76.7% (69.0 - 84.6%)
Negative Agreement²	High, to agree with IgM IFA negative results (worst-case scenario)	96.4% (93.7 – 98.2%)
Adjusted Positive Agreement (no indeterminates)	Higher, when indeterminate samples are excluded	89.6% (81.7 - 94.9%)
Adjusted Negative Agreement (no indeterminates)	Higher, when indeterminate samples are excluded	98.7% (96.6 - 99.6%)
Study Site 2 (Clinical - PRNT Confirmed)
Clinical Sensitivity	High, to detect WNV infection in symptomatic patients	100.0% (93.0 - 100.0%)
Specificity of IgM Detection	Device should specifically detect IgM antibodies	DTT treatment showed significant decrease in absorbance (IgM removal); IgG absorbent showed no effect on IgM reactivity. (Qualitative)
Reproducibility (CV%)	Low variability across runs and sites	Total CV% for various samples ranged from 2.6% (Cut-off) to 16.8% (Negative).
Cross-Reactivity	Low reactivity with other common diseases	3.8% Overall Reactive (6/160 samples); primarily with Dengue virus (2/16) and Rheumatoid Factor (4/15, including 1 equivocal).

*CI = Exact confidence interval
¹ Sixteen samples testing indeterminate by IFA and negative by PANBIO were assigned to "IgM positive" for worst-case.
² Seven samples testing indeterminate by IFA and positive by PANBIO were assigned to "IgM negative" for worst-case.

2. Sample Sizes Used for the Test Set and Data Provenance

Study Site 1:
- Total Samples: 420 retrospective sera
- PRNT-confirmed subset: 130 samples (61 WNV positive, 69 WNV negative)
- CDC MAC EIA presumptively characterized subset: 73 samples (11 WNV positive, 62 WNV negative)
- IgM IFA presumptively characterized subset: 419 samples (96 IgM positive, 23 indeterminate, 300 negative) (Note: The sum is 419, not 420. One sample might have been excluded or lost from the initial 420).
- Data Provenance (Country of Origin and Retrospective/Prospective): Retrospective sera from individuals in various locations:
  - California, USA (blood donation center)
  - Maryland, USA (private reference laboratory)
  - Utah, USA (private reference laboratory)
  - Texas, USA (university medical branch)
  - Minnesota, USA (private laboratory)
  - Canada (government medical laboratory)
Study Site 2:
- Total Samples: 51 retrospective sera confirmed by PRNT. These were encephalitis/meningitis patients.
- Data Provenance (Country of Origin and Retrospective/Prospective): Retrospective sera from patients collected in 2002 at a hospital laboratory in Ohio, USA.
Specificity of IgM Detection: 10 serum samples for DTT treatment, 8 serum samples for IgG interference. Provenance not specified but likely conducted in-house.
Reproducibility: Not directly a test set for clinical performance; 27 observations for each of 9 samples.
Cross-Reactivity: 160 specimens from patients with confirmed diseases other than WNV. Provenance not explicitly stated for individual samples, but the study was conducted at "Study Site 1" and "Study Site 2" (Ohio) and in-house at PANBIO.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with X years of experience) who established the ground truth for the test sets. Instead, the ground truth was established by:

Plaque Reduction Neutralization Test (PRNT): A laboratory method considered the gold standard for WNV confirmation. This is a laboratory assay, not an expert panel judgment in the traditional sense.
CDC MAC EIA: Presumptive characterization based on another laboratory assay.
WNV IgM IFA: Presumptive characterization based on another laboratory assay.

The characterization of specimens was performed by recognized laboratory methods, not by human expert adjudication of individual cases.

4. Adjudication Method for the Test Set

The ground truth for the clinical performance studies was established using laboratory reference assays:

Plaque Reduction Neutralization Test (PRNT): Used to "confirm" WNV positive/negative status for the primary sensitivity/specificity calculations. This acts as the independent "adjudicator."
CDC MAC EIA and WNV IgM IFA: Used for presumptive characterization for additional agreement studies.

There was no human expert adjudication method described (e.g., 2+1, 3+1 consensus) for the test sets. The laboratory results themselves served as the reference standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.

This device is an Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of IgM antibodies, which means it is a laboratory diagnostic test. It is not an AI-powered device or an imaging interpretation system that would involve human readers or AI assistance in the way typically discussed in MRMC studies. The device itself performs the detection.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance study was a standalone (algorithm only) evaluation.

The PANBIO West Nile Virus IgM Capture ELISA is an in-vitro diagnostic device that directly produces a result (positive, equivocal, negative) based on the biochemical reaction. Its performance was evaluated by directly comparing its output to established reference laboratory methods (PRNT, CDC MAC EIA, IgM IFA). There is no "human-in-the-loop" component in the sense of a human interpreting the device's output to make a primary diagnosis; the output is the diagnostic aid.

7. The Type of Ground Truth Used

The ground truth used in the performance studies was primarily laboratory reference assays:

Plaque Reduction Neutralization Test (PRNT): Considered the gold standard for WNV confirmation.
CDC MAC EIA (ELISA): Another established laboratory assay for WNV IgM detection.
WNV IgM IFA (Immunofluorescence Assay): Another laboratory assay for WNV IgM detection.

For the cross-reactivity study, the ground truth was based on specimens from patients with confirmed diseases other than WNV.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of device development. This is typical for traditional ELISA-based diagnostic kits, where the assay principles and reagents are developed and optimized rather than "trained" in the machine learning sense. The performance characteristics are then verified using independent test sets as described.

9. How the Ground Truth for the Training Set Was Established

Since a "training set" (as understood in machine learning/AI) is not typically applicable to this type of device, the concept of establishing ground truth for it is also not relevant here. The device's components and parameters are likely optimized through laboratory R&D processes based on known positive and negative controls.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 1.9

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: To be allocated

Applicant Information:

Submission Date:	6th May 2004
Date Modified:	5th August 2004
Name:	PANBIO Limited
Address:	116 Lutwyche Road, WindsorQueensland 4030 Australia
Contact Person:	Craig Breadmore / Kate Wersin
Phone Number:Fax Number:	+61-(0)7-3357-1177+61-(0)7-3357-1222

Device Information:

Trade Name:	West Nile Virus IgM Capture ELISA
Common Name:	West Nile Virus IgM Capture EIA Test
Classification Name:	West Nile virus, serological reagents (21 CFR 866.3940)

Equivalent Device:

Equivalence to the PANBIO West Nile Virus IgM Capture ELISA (E-WNV01M -510(k): K031703) is claimed and shall be demonstrated via the enclosed performance data. The PANBIO West Nile Virus IgM Capture ELISA, E-WNV02M, is identical in intended use to the 510(k)-cleared E-WNV01M device. Modifications to the E-WNV02M antigen and conjugate format have resulted in improved performance of the device. The re-designed E-WNV02M device in this submission is intended to supersede the E-WNV01M 510(k)-cleared version on the US market.

Device Description:

Intended Use:

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Principle of Procedure:

Principle of Procedure.
Serum antibodies of the IgM class combine with antibodies attached to the Serum antibodies of the igin cluse of the ray plate). Residual serum is removed from the management polysiyrene Surface of the microwen toor only polity the conjugated monoclonal the "assay" plate" by "washing" write" and on the microwells are washed and anubody (Mab) is added to the usedy plater Piter Readen (TMB/H2O2) is added. a Coloness Substrate of Chan LEP, if present, and the chromogen changes to a blue The Substrate is Tiyuloryzon by the Than in process, the TMB becomes yellow. Color development is color: "Alter Stopping the roll WNV antibodies in the test sample.

PERFORMANCE CHARACTERISTICS

Study Site 1:

Four hundred and twenty (420) retrospective sera from individuals of various ages and both Pour hundred and twenty (420) relieved included samples from the following groups: 121 genders were tostod at PARCET on center in California, USA, 115 endemic negative endemic sumples from a private reference laboratory in Maryland, USA, 132 specimens from specifiens from a private reference laboratory in Utah, USA, 26 patiens from patients presenting for WNV testing at a university medical branch in Texas, Specimens from patients presenting for WNV testing from a private laboratory in OUA, and 20 spoolinene from pales 130 were pre-characterized by PRNT, 73 had CDC MAC Minnesola, Ook. Of those samples These samples were subsequently tested on the PANBIO West Nile Virus IgM Capture ELISA to determine assay performance. The data is summarized in Tables 1, 2 and 3.

Specimen Characterization b(Confirmed by PRNT)	PANBIO IgM ELISA Result
	Pos	Eqv a	Neg	Total
WNV positive	59	0	2d	61
WNV negative	9c	1	59	69
Total	68	1	61	130

Table 1 - Study Site 1 Reactivity with PRNT

Table 2 - Study Site 1 Reactivity with CDC MAC EIA umptively Characterized Specimens

Specimen Characterization °	PANBIO IgM ELISA Result
(Presumptive by CDC MAC EIA)	Pos	Eqv a	Neg	Total
WNV positive	11	0	0	11
WNV negative	1	0	61	62
Total	12	0	61	73

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Specimen Characterization(Presumptive by WNV IgM IFA)f	PANBIO IgM ELISA Result
	Pos	Eqva	Neg	Total
WNV positive	86	0	10	96
Indeterminateg	7h	0	16i	23
WNV negative	3	1	296	300
Total	96	1	322	419

Table 3 - Study Site 1 Reactivity with IgM IFA

a Equivocal samples were not repeated.

" Equirosa campion in a blood donation centre in California, USA, and a government medical laboratory in Canada.

1 MNV RRNT negative / PANBIO JgM ELISA positive: Further investigation of the discrepant nature of these samples identified that most (7/9) were presumptively IgM positive (CDC MAC EIA = 2, IgM IFA ASR = 5).

deemiled that hour (110) Welcompany wither investigation of the discrepant nature identified that these samples (n=2) were presumptively IgM negative (CDC MAC EIA = 1, IgM IFA ASR = 1).

® CDC MAC EIA testing conducted at PANBIO.

1 FA testing conducted at PANBIO and a private reference laboratory in Utah, USA using the PANBIO IgM IFA ASR.

If A result Conduction of ANDRO and a pinctioninate results. This was the product of non-specific staining yelding an unacceptably high background making it not possible to make a reliable interpretation.

yelling an anaooopiday ingh bangreamal were further characterised by PRNT with 5 yielding a positive reaction and 2 a

negative reaction.
' Fifteen of the 16 sera were tested by MAC ELISA and yielded a negative result. Six of these 15 sera were tested by PRNT and yielded negative reactions. The one sample not tested by MAC ELISA tested negative by PRNT.

WNV (confirmed by PRNT)		95% CI*
Serological sensitivity = 59/61	96.7%	88.7 – 99.6%
Serological specificity = 59/69	85.5%	75.0 - 92.8%
WNV (presumptive by CDC MAC EIA)
Positive agreement = 11/11	100%	71.5 – 100%
Negative agreement = 61/62	98.4%	91.3 – 100%
WNV (presumptive by IgM IFA)
Positive agreement1 = 86/112	76.7%	69.0 - 84.6%
Negative agreement2 = 296/307	96.4%	93.7 – 98.2%

1 The 16 samples testing indeterminate by IFA and negative by the PANBIO WNV IgM were intentionally assigned to the "IgM positive" category for the purpose of this calculation yielding a worst-case scenario.

2 The 7 samples testing indeterminate by IFA and positive by the PANBIO WNV IgM were intentionally assigned to the "IgM negative" category for the purpose of this calculation yielding a worst-case scenario.

nugative "daogory for the parpose of the conspecific staining. If indeterminate samples were eliminated from the data set the positive agreement would be 89.6% (Cl 81.7 - 94.9%) and the negative agreement 98.7% (Cl 96.6 - 99.6%).

*CI = Exact confidence interval

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Study Site 2

Study Site 2 Filly-one (51) Tellospective Serient patient was a hospital laboratory in Ohio, USA.
confirmed by PRNT for WNV antibodies, were tested at a hospital laboratory in Ohio, USA. conlimed by PRNT for WNV antibodios, were were and both genders in 2002 and tested The sera were collected from Individually of Various agos an interesults were compared to the In 2004 on the 1 ANDIO Wood mis as a most and secure to determine the performance of the assay. The data is summarized in Table 4.

Table 4 – Study Site 2Reactivity with Encephalitis / Meningitis Patientand Endemic Patient Specimens
Specimen Characterization	PANBIO IgM ELISA Result(E-WNV02M)	Pos	Eqv	Neg	Total
Encephalitis / meningitis patients(E-WNV01M & PRNT positive)a		51	0	0	51

2 Encephalitis / meningting C TRIT pocking of the Pool in 2002. Samples were tested by WNV PRNT and further tested on the E-WNV02M device.

Encephalitis / meningitis patients (documented WNV infection by PRNT)

		95% CI*
Clinical sensitivity (with PRNT) = 51/51	100.0%	93.0 - 100.0%

*CI = Exact confidence interval

An additional six acute serum specimens, without PRNT information, from individuals with /in additional of encephalitis who had evidence of specific anti-WNV IgM being present in CSF were tested. Due to anti-WNV IgM being present in CSF these individuals were in Oor word to have WNV associated-encephalitis. When the serum specimens were tested with the PANBIO WNV IgM test all specimen results were negative.

SPECIFICITY OF IgM DETECTION

A study consisting of 10 serum samples with varying levels of IgM antibodies was conducted A study of lot of to of to of an other tion in the PANBIO West Nile Virus IgM Capture ELISA. The samples were treated with 0.005M Dithiothreitol (DTT) to remove IgM antibodies. The untreated and treated samples were then tested on the PANBIO West Nile Virus IgM Capture treator and trouted samples showed a significant decrease in absorbance. A further study consisting of 8 serum samples with known levels of IgM and IgG antibodies to WNV showed no effect on IgM reactivity when these samples were treated with a goat anti-human IgG absorbent. These studies indicate that the assay is specific for IgM antibodies and that specific WNV IgG antibodies do not interfere with the assay.

EFFECTS OF FREEZE-THAW CYCLES

A study consisting of 8 serum samples with varying levels of IgM antibodies to WNV was conducted to determine the effects of multiple freeze-thaw cycles on the detection of WNV IgM antibodies in patient sera. This study indicates that five freeze-thaw cycles have little effect on the detection of IgM antibodies, and therefore it is recommended that samples may undergo up to three freeze-thaw cycles for testing purposes.

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REPRODUCIBILITY

The reproducibility of the PANBIO West Nile Virus IgM Capture ELISA was The reproduciblity of the PANDIS each on 3 different assays at one Australian delemined by testing of other of the USA. Within-run, between site and study site and two study sites in the obsir of Variance (ANOVA Type II). The results are presented in Table 5 below.

Precision Measures (Using Index Value)
Sample	n	*Mean	Within		Between Day		Between Site		Total
			*S.D	CV	*S.D	CV	*S.D	CV	*S.D	CV
Positive	27	2.63	0.18	7.0%	0.00	0.0%	0.28	10.6%	0.29	11.2%
Cut-off	27	1.00	0.03	2.8%	0.00	0.0%	0.00	0.0%	0.03	2.6%
Negative	27	0.23	0.03	13.7%	0.00	0.0%	0.03	12.3%	0.04	16.8%
#1	27	2.77	0.18	6.6%	0.06	2.3%	0.43	15.7%	0.41	14.7%
#2	27	2.63	0.09	3.5%	0.00	0.0%	0.31	11.9%	0.28	10.5%
#3	27	3.26	0.10	2.9%	0.00	0.0%	0.40	12.4%	0.35	10.7%
#4	27	1.23	0.04	2.8%	0.00	0.0%	0.12	9.4%	0.10	8.3%
#5	27	1.20	0.05	4.3%	0.01	0.6%	0.10	8.6%	0.10	8.3%
#6	27	1.44	0.06	4.1%	0.02	1.6%	0.15	10.1%	0.14	9.5%
#7	27	0.83	0.04	4.7%	0.01	1.0%	0.08	9.6%	0.08	9.3%
#8	27	1.04	0.06	5.3%	0.00	0.0%	0.09	8.7%	0.09	8.9%

Table 5 - Reproducibility Study (Three Sites) ision Measures (Using Index Value*)

All values are calculated from Index values (Cut-Off using O.D) SD = Standard Deviation; CV = Coefficient of Variation

Note: Standard Deviation results have been rounded to two decimal places for tabulation purposes. * Index value is calculated by dividing the sample absorbance by the cut-off value.

CROSS REACTIVITY

This study consisted of a panel of 160 specimens from patients with confirmed diseases other than WNV. The purpose of this study was to establish the analytical specificity of the PANBIO West Nile Virus IgM Capture ELISA through the analysis of specimens from patients with diseases that have the potential for cross-reactivity. Each of the specimens included in the study was characterised with respect to disease state prior to analysis of the specimens with the PANBIO West Nile Virus IgM Capture ELISA. Table 6 below provides a summary of specimens in the disease panel outlined in Table 7.

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Disease State	Study Site	PANBIO IgG ELISA Results
		Pos	Eqv	Total Reactive
Epstein-Barr virus	1	0	0	0/15 0.0%
Varicella-Zoster virus	1	0	0	0/15 0.0%
Cytomegalovirus	1	0	0	0/15 0.0%
Ross River virus	1	0	0	0/26 0.0%
Enterovirus	1	0	0	0/7 0.0%
Dengue virus	1	2	0	2/16 12.5%
St. Louis encephalitis	1	0	0	0/6 0.0%
La Crosse encephalitis	1, 2a	0	0	0/19 0.0%
Hepatitis A	1	0	0	0/11 0.0%
Anti-Nuclear Antibody	1	0	0	0/15 0.0%
Rheumatoid Factor	1	3	1	4/15 26.7%
Total		5	1	6/160 3.8%

Table 6 – Summary of Cross-reactivity Study PANBIO West Nile Virus IgM Capture ELISA (E-WNV02M)

a Samples tested in-house at PANBIO except for 9/19 La Crosse encephalitis - Gamples toolou in nouos it il house it in Ohio, USA.

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TABLE 7 Results of Cross-reactivity Study

Sample	Site	IgM Antibody Type	PANBIO E-WNV02MELISA Result
			Index	Result
1	1	La Crosse encephalitis	0.47	N
2	1	La Crosse encephalitis	0.28	N
3	1	La Crosse encephalitis	0.34	N
4	1	La Crosse encephalitis	0.26	N
5	1	La Crosse encephalitis	0.31	N
6	1	La Crosse encephalitis	0.30	N
7	1	La Crosse encephalitis	0.58	N
8	1	La Crosse encephalitis	0.38	N
9	1	La Crosse encephalitis	0.31	N
10	1	La Crosse encephalitis	0.37	N
11	2	La Crosse encephalitis	0.39	N
12	2	La Crosse encephalitis	0.34	N
13	2	La Crosse encephalitis	0.38	N
14	2	La Crosse encephalitis	0.32	N
15	2	La Crosse encephalitis	0.45	N
16	2	La Crosse encephalitis	0.25	N
17	2	La Crosse encephalitis	0.24	N
18	2	La Crosse encephalitis	0.30	N
19	2	La Crosse encephalitis	0.25	N
20	1	Saint Louis encephalitis	0.31	N
21	1	Saint Louis encephalitis	0.23	N
22	1	Saint Louis encephalitis	0.21	N
23	1	Saint Louis encephalitis	0.27	N
24	1	Saint Louis encephalitis	0.27	N
25	1	Saint Louis encephalitis	0.23	N
26	1	Rheumatoid Factor	0.18	N
27	1	Rheumatoid Factor	4.84	P
28	1	Rheumatoid Factor	1.86	P
29	1	Rheumatoid Factor	3.76	P
30	1	Rheumatoid Factor	0.25	N
31	1	Rheumatoid Factor	0.33	N
32	1	Rheumatoid Factor	0.98	E
33	1	Rheumatoid Factor	0.41	N
34	1	Rheumatoid Factor	0.34	N
35	1	Rheumatoid Factor	0.61	N
36	1	Rheumatoid Factor	0.36	N
37	1	Rheumatoid Factor	0.24	N
38	1	Rheumatoid Factor	0.54	N
39	1	Rheumatoid Factor	0.44	N
Sample	Site	IgM Antibody Type	PANBIO E-WNV02MELISA Result
			Index	Result
40	1	Rheumatoid Factor	0.42	N
41	1	Anti-Nuclear Antibody	0.23	N
42	1	Anti-Nuclear Antibody	0.20	N
43	1	Anti-Nuclear Antibody	0.22	N
44	1	Anti-Nuclear Antibody	0.27	N
45	1	Anti-Nuclear Antibody	0.18	N
46	1	Anti-Nuclear Antibody	0.25	N
47	1	Anti-Nuclear Antibody	0.24	N
48	1	Anti-Nuclear Antibody	0.20	N
49	1	Anti-Nuclear Antibody	0.24	N
50	1	Anti-Nuclear Antibody	0.25	N
51	1	Anti-Nuclear Antibody	0.28	N
52	1	Anti-Nuclear Antibody	0.26	N
53	1	Anti-Nuclear Antibody	0.41	N
54	1	Anti-Nuclear Antibody	0.27	N
55	1	Anti-Nuclear Antibody	0.18	N
56	1	Hepatitis A	0.33	N
57	1	Hepatitis A	0.35	N
58	1	Hepatitis A	0.23	N
59	1	Hepatitis A	0.22	N
60	1	Hepatitis A	0.21	N
61	1	Hepatitis A	0.44	N
62	1	Hepatitis A	0.38	N
63	1	Hepatitis A	0.31	N
64	1	Hepatitis A	0.26	N
65	1	Hepatitis A	0.69	N
66	1	Hepatitis A	0.46	N
67	1	Epstein-Barr virus	0.17	N
68	1	Epstein-Barr virus	0.26	N
69	1	Epstein-Barr virus	0.22	N
70	1	Epstein-Barr virus	0.21	N
71	1	Epstein-Barr virus	0.26	N
72	1	Epstein-Barr virus	0.42	N
73	1	Epstein-Barr virus	0.25	N
74	1	Epstein-Barr virus	0.20	N
75	1	Epstein-Barr virus	0.26	N
76	1	Epstein-Barr virus	0.25	N
77	1	Epstein-Barr virus	0.27	N
78	1	Epstein-Barr virus	0.25	N
79	1	Epstein-Barr virus	0.33	N
80	1	Epstein-Barr virus	0.33	N
81	1	Epstein-Barr virus	0.34	N
Sample	Site	IgM Antibody Type	PANBIO E-WNV02MELISA Result
			Index	Result
82	1	Dengue virus	0.59	N
83	1	Dengue virus	0.32	N
84	1	Dengue virus	0.30	N
85	1	Dengue virus	0.36	N
86	1	Dengue virus	0.51	N
87	1	Dengue virus	0.40	N
88	1	Dengue virus	0.33	N
89	1	Dengue virus	1.26	P
90	1	Dengue virus	1.27	P
91	1	Dengue virus	0.37	N
92	1	Dengue virus	0.32	N
93	1	Dengue virus	0.27	N
94	1	Dengue virus	0.30	N
95	1	Dengue virus	0.56	N
96	1	Dengue virus	0.41	N
97	1	Dengue virus	0.48	N
98	1	Cytomegalovirus	0.43	N
99	1	Cytomegalovirus	0.24	N
100	1	Cytomegalovirus	0.27	N
101	1	Cytomegalovirus	0.53	N
102	1	Cytomegalovirus	0.31	N
103	1	Cytomegalovirus	0.51	N
104	1	Cytomegalovirus	0.39	N
105	1	Cytomegalovirus	0.41	N
106	1	Cytomegalovirus	0.34	N
107	1	Cytomegalovirus	0.54	N
108	1	Cytomegalovirus	0.33	N
109	1	Cytomegalovirus	0.22	N
110	1	Cytomegalovirus	0.27	N
111	1	Cytomegalovirus	0.37	N
112	1	Cytomegalovirus	0.52	N
113	1	Varicella-Zoster virus	0.34	N
114	1	Varicella-Zoster virus	0.55	N
115	1	Varicella-Zoster virus	0.23	N
116	1	Varicella-Zoster virus	0.31	N
117	1	Varicella-Zoster virus	0.30	N
118	1	Varicella-Zoster virus	0.23	N
119	1	Varicella-Zoster virus	0.28	N
120	1	Varicella-Zoster virus	0.69	N
121	1	Varicella-Zoster virus	0.24	N
122	1	Varicella-Zoster virus	0.24	N
123	1	Varicella-Zoster virus	0.21	N
Sample	Site	IgM Antibody Type	PANBIO E-WNV02MELISA Result
			Index	Result
124	1	Varicella-Zoster virus	0.27	N
125	1	Varicella-Zoster virus	0.31	N
126	1	Varicella-Zoster virus	0.20	N
127	1	Varicella-Zoster virus	0.40	N
128	1	Ross River virus	0.26	N
129	1	Ross River virus	0.28	N
130	1	Ross River virus	0.23	N
131	1	Ross River virus	0.30	N
132	1	Ross River virus	0.24	N
133	1	Ross River virus	0.26	N
134	1	Ross River virus	0.20	N
135	1	Ross River virus	0.17	N
136	1	Ross River virus	0.27	N
137	1	Ross River virus	0.25	N
138	1	Ross River virus	0.60	N
139	1	Ross River virus	0.28	N
140	1	Ross River virus	0.23	N
141	1	Ross River virus	0.19	N
142	1	Ross River virus	0.21	N
143	1	Ross River virus	0.23	N
144	1	Ross River virus	0.39	N
145	1	Ross River virus	0.17	N
146	1	Ross River virus	0.18	N
147	1	Ross River virus	0.21	N
148	1	Ross River virus	0.24	N
149	1	Ross River virus	0.21	N
150	1	Ross River virus	0.27	N
151	1	Ross River virus	0.19	N
152	1	Ross River virus	0.22	N
153	1	Ross River virus	0.15	N
154	1	Enterovirus	0.42	N
155	1	Enterovirus	0.34	N
156	1	Enterovirus	0.27	N
157	1	Enterovirus	0.28	N
158	1	Enterovirus	0.19	N
159	1	Enterovirus	0.27	N
160	1	Enterovirus	0.29	N

{7}------------------------------------------------

{8}------------------------------------------------

・

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INTERPRETATION

ELISA	Positive = P	Equivocal	Negative = N
PANBIO Index	> 1.1	0.9 - 1.1	< 0.9

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Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 0 2004

Ms. Kate Wersin Regulatory Affairs Officer PANBIO Limited. 116 Lutwyche Road, Windsor Brisbane, Queensland 4030 Australia

K041231 Re:

Ro 11251
Trade/Device Name: West Nile Virus IgM Capture ELISA Regulation Number: 21 CFR 866.3940 Regulation Name: West Nile Virus Serological Reagents Regulatory Class: Class II Product Code: NOP Dated: May 6, 2004 Received: May 10, 2004

Dear Ms. Wersin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalled in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally atment date of the Medical Device Amendments, or to commence prof to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been roomsomed in assee approval of a premarket approval application (PMA). and Costile Act (11ct) that as nevice, subject to the general controls provisions of the Act. The 1 ou may, dicierore, market the act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device n may be subject to suen additions come Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in Thic 21, Occasions concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised hat i Dri 3 issualles or our device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. You must of any I cach statutes and regulations and limited to: registration and listing (21 comply with an the 11st 510qurt Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{11}------------------------------------------------

Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to organ maxing of substantial equivalence of your device to a legally premarket notification: "The PDA milling of basification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, II you desire specific monitation assocertising of your device, please contact the Office of of questions on the promotion and Safety at (301) 594-3084. Also, please note the In Vill o Diagnostic De rose Bing by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the 1 ou may oodain other general and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Saartys

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{12}------------------------------------------------

Indications for Use

510(k) Number (if known): K041231

West Nile Virus IgM Capture ELISA Device Name:

Indications for Use: The PANBIO West Nile Virus IgM Capture ELISA is for the qualitative The PANBIO West Nic Virus Igni Sapato West Nile virus in serum as
presumptive detection of IgM antibodies to West Nile virus informing information in presumptive detection of ight a laboratory diagnosis of West Nile virus infection in an all in the clinical laboratory andgracts with encephalitis / meningitis. Positive results must be confirmed by plaque reduction neutralization Positive Tesults Thust be continue by plaque in Disease Control and test (FTNT), or by doing the room of this disease.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Nagatz
Division Sign-Off

Office of In Vitro Dlagnostic Device Evaluation and Safety

Page 1 of 1

510(k) _ KORTS 31

Regulation Number and Section

§ 866.3940 West Nile virus serological reagents.

(a)
Identification. West Nile virus serological reagents are devices that consist of antigens and antisera for the detection of anti-West Nile virus IgM antibodies, in human serum, from individuals who have signs and symptoms consistent with viral meningitis/encephalitis. The detection aids in the clinical laboratory diagnosis of viral meningitis/encephalitis caused by West Nile virus.(b)
Classification. Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus.” See § 866.1(e) for the availability of this guidance document.