WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M

K041231 · Panbio Limited · NOP · Aug 10, 2004 · Microbiology

Device Facts

• Record ID: K041231
• Device Name: WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M
• Applicant: Panbio Limited
• Product Code: NOP · Microbiology
• Decision Date: Aug 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3940
• Device Class: Class 2

Indications for Use

The PANBIO West Nile Virus IgM Capture ELISA is for the qualitative presumptive detection of IgM 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 Story

The West Nile Virus IgM Capture ELISA is an in vitro diagnostic assay used in clinical laboratories to detect IgM antibodies in patient serum. The device utilizes a polystyrene microwell plate coated with anti-human IgM antibodies to capture IgM from the patient sample. After washing, West Nile virus antigen is added, followed by a conjugated monoclonal antibody. A TMB/H2O2 substrate is then added, causing a color change (blue to yellow upon stopping) proportional to the amount of WNV-specific IgM present. Results are interpreted via an index value calculated from the sample absorbance relative to a cut-off. The test aids physicians in diagnosing WNV infection in symptomatic patients; positive results require confirmation via plaque reduction neutralization test (PRNT) or CDC guidelines. The device provides a qualitative result to support clinical decision-making.

Clinical Evidence

Clinical performance evaluated using 420 retrospective sera (Study Site 1) and 51 prospective patient samples (Study Site 2). Sensitivity was 96.7% (95% CI: 88.7–99.6%) and specificity 85.5% (95% CI: 75.0–92.8%) against PRNT-confirmed samples. Positive agreement with CDC MAC EIA was 100% and negative agreement 98.4%. Clinical sensitivity in encephalitis/meningitis patients confirmed by PRNT was 100% (95% CI: 93.0–100.0%). Cross-reactivity testing included 160 specimens from patients with other diseases; potential cross-reactivity noted with Rheumatoid Factor.

Technological Characteristics

Enzyme Linked Immunosorbent Assay (ELISA) format. Uses polystyrene microwell plates. Detection principle: colorimetric reaction using TMB/H2O2 substrate. Manual assay procedure. Specificity for IgM confirmed via DTT treatment and anti-human IgG absorbent studies. Not for use on automated instruments.

Indications for Use

Indicated for qualitative presumptive detection of IgM antibodies to West Nile virus in serum as an aid in clinical diagnosis of West Nile virus infection in patients with symptoms consistent with encephalitis or meningitis. Not for cord blood, neonates, prenatal screening, or general population screening. Contraindicated for use with automated instruments.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• PANBIO West Nile Virus IgM Capture ELISA (K031703)

Submission Summary (Full Text)

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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, Windsor<br>Queensland 4030 Australia |
| Contact Person: | Craig Breadmore / Kate Wersin |
| Phone Number:<br>Fax Number: | [phone]<br>[phone] |

### 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:

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.

### Intended Use:

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.

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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<br>(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<br>(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 2<br>Reactivity with Encephalitis / Meningitis Patient<br>and Endemic Patient Specimens | | | | | |
|--------------------------------------------------------------------------------------------------------------|---------------------------------------|-----|-----|-----|-------|
| Specimen Characterization | PANBIO IgM ELISA Result<br>(E-WNV02M) | Pos | Eqv | Neg | Total |
| Encephalitis / meningitis patients<br>(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-WNV02M<br>ELISA 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-WNV02M<br>ELISA 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-WNV02M<br>ELISA 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-WNV02M<br>ELISA 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).

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### 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 [phone]. 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 [phone] or [phone] 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

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# 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

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510(k) _ KORTS 31