EBV VCA-P18 IGG ELISA
Device Facts
| Record ID | K030863 |
|---|---|
| Device Name | EBV VCA-P18 IGG ELISA |
| Applicant | Panbio Limited |
| Product Code | LSE · Microbiology |
| Decision Date | Jun 27, 2003 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3235 |
| Device Class | Class 1 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K030863 · Jun 27, 2003 | EBV VCA-P18 IGG ELISA | Panbio Limited | Retrospective clinical serum samples from private pathology laboratories; Retrospective clinical serum samples from a state health laboratory | Retrospective clinical samples were used to evaluate the sensitivity, specificity, and agreement of the PANBIO EBV VCA-p18 IgG ELISA compared to a predicate device and established EBV serological status. | Retrospective study; Clinical laboratory samples; Performance validation |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Retrospective clinical performance study | 342 prospective sera (seronegative, acute infectious mononucleosis, and past exposure); Sample Size: 342; Number of Sites: 1 | DiaSorin EBV VCA IgG ELISA | Sensitivity, specificity, and agreement relative to EBV serological status |
| Retrospective clinical performance study | 148 frozen retrospective sera (seronegative, acute infectious mononucleosis, and past exposure); Sample Size: 148; Number of Sites: 1 | DiaSorin EBV VCA IgG ELISA | Sensitivity, specificity, and agreement relative to EBV serological status |
Indications for Use
The Epstein Barr Virus Viral Capsid-p18 Antigen (EBV VCA-p18) IgG ELISA Test is for the qualitative detection of IgG antibodies to EBV VCA in serum as an aid in the clinical laboratory diagnosis of EBV infection in patients with clinical symptoms consistent with Infectious Mononucleosis (IM). The PANBIO EBV VCA-p18 IgG ELISA should be used in conjunction with other EBV serologies.
Device Story
The EBV VCA-p18 IgG ELISA is an in vitro diagnostic test used in clinical laboratories. It utilizes a synthetically produced EBV VCA-p18 peptide antigen attached to polystyrene microwells. Patient serum is added; if IgG antibodies to VCA are present, they bind to the antigen. After washing, peroxidase-conjugated anti-human IgG is added, followed by a TMB/H2O2 substrate system. The enzymatic reaction produces a color change (blue, then yellow after acid stop) proportional to the amount of bound IgG. Results are interpreted by healthcare providers to aid in the diagnosis of EBV infection. The device is intended for use in conjunction with other EBV serologies to support clinical decision-making for patients presenting with symptoms of infectious mononucleosis.
Clinical Evidence
Clinical performance evaluated across two study sites (Australia and USA) using 490 total prospective and retrospective serum samples. Compared against the DiaSorin EBV VCA IgG ELISA and established EBV serological status. In Australian study (n=342), relative sensitivity for acute infection was 68.3% and specificity 100%. In US study (n=148), relative sensitivity for acute infection was 73.9% and specificity 96.0%. Reproducibility testing (n=27 per sample) showed total CVs ranging from 4.1% to 13.9%. Analytical specificity evaluated against a panel of 30 specimens (CMV, VZV, HSV, ANA, RF) showed 1/30 cross-reactivity.
Technological Characteristics
Enzyme-Linked Immunosorbent Assay (ELISA) using synthetic EBV VCA-p18 peptide antigen coated on polystyrene microwells. Detection via peroxidase-conjugated anti-human IgG and TMB/H2O2 substrate. Manual or automated plate processing. Results determined by absorbance measurement.
Indications for Use
Indicated for qualitative detection of IgG antibodies to EBV VCA in human serum as an aid in clinical laboratory diagnosis of EBV infection in patients with symptoms consistent with infectious mononucleosis (IM).
Regulatory Classification
Identification
Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).
Predicate Devices
- DiaSorin EBV VCA IgG ELISA
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for PANBIO. The logo consists of a circular graphic on the left and the word "PANBIO" in bold, sans-serif letters on the right. The graphic appears to be an abstract design, possibly representing biological elements. The overall impression is a clean and professional logo for a company in the biotechnology or related field.
#### 10(k) SUMMARY OF SAFETY AND EFFECTIVENESS 1.10
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:
## Applicant Information:
| Date Prepared: | 12th March, 2003 |
|----------------|---------------------------------------------------------|
| Name: | PANBIO Limited |
| Address: | 116 Lutwyche Road, Windsor<br>Queensland 4030 Australia |
| Contact Person: | Helen Jennings |
|-----------------|--------------------|
| Phone Number: | +61-(0)7-3357-1177 |
| Fax Number: | +61-(0)7-3357-1222 |
### Device Information:
| Trade Name: | EBV VCA-p18 IgG ELISA |
|----------------------|------------------------------------------|
| Common Name: | EBV VCA IgG EIA Test |
| Classification Name: | Epstein-Barr virus serological reagents. |
## Equivalent Device:
DiaSorin EBV VCA IgG ELISA
## Device Description:
The EBV VCA-p18 IgG ELISA is an Enzyme Linked Immunosorbent Assay for the qualitative detection of IgG antibodies in human serum to EBV VCA antigen.
## Intended Use:
The Epstein-Barr Virus Viral Capsid-p18 Antigen (EBV VCA-p18) IgG ELISA is for the qualitative detection of IgG antibodies to EBV VCA in serum as an aid in the clinical laboratory diagnosis of EBV infection in patients with clinical symptoms consistent with infectious mononucleosis (IM). The PANBIO EBV VCA-p18 IgG ELISA should be used in conjunction with other EBV serologies.
#### Principle of Procedure:
Serum containing antibodies to VCA antigen, when present, combine with EBV VCA-p18 antigen attached to the polystyrene surface of the microwells. The antigen is a synthetically produced peptide. Residual serum is removed by washing and peroxidase conjugated antihuman IgG is added. The microwells are washed and a colourless substrate system, tetramethylbenzidine/hydrogen peroxide (TMB/H₂O₂) is added. The substrate is hydrolysed by the enzyme and the chromogen changes to a blue colour. After stopping the reaction with acid, the TMB becomes yellow. Colour development is indicative of the presence of EBV VCA IgG antibodies in the test sample.
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Image /page/1/Picture/0 description: The image shows the word "PANBIO" in bold, black letters. To the left of the word is a circular logo with a stylized design. The logo appears to be textured or distressed, giving it a slightly rough appearance. The overall image has a clean and professional look.
### PERFORMANCE CHARACTERISTICS
### Study Site 1:
342 prospective sera of various ages and genders were tested at a private pathology laboratory in Queensland, Australia for EBV testing. The sera include the following groups: 45 seroneqative, 41 with acute infectious mononucleosis and 256 with past exposure to EBV.
These sera were tested on the PANBIO EBV VCA-p18 IgG ELISA and the DiaSorin EBV VCA IgG ELISA. The PANBIO results were compared to the EBV status of the sera to determine the sensitivity, specificity, and agreement of the assay relative to the EBV serological status (Table 1). Additionally, the DiaSorin results were compared to the EBV serological status (Table 2) and PANBIO results (Table 3), as summarised below.
| PANBIO ELISA | | | |
|--------------------------------------------------------------|----------|----------|-------|
| EBV Status | Positive | Negative | Total |
| Seronegative<br>VCA IgG (-)<br>VCA IgM (-)<br>EBNA IgG (-) | 0 | 45 | 45 |
| Acute<br>VCA IgM (+)<br>EBNA IgG (-) | 28 | 13 | 41 |
| Past Infection<br>VCA IgG (+)<br>VCA IgM (-)<br>EBNA IgG (+) | 242 | 14 | 256 |
| Total | 270 | 72 | 342 |
# TABLE 1 EBV STATUS VERSUS PANBIO ELISA
| Relative Sensitivity (Acute) | = | | | 95% Confidence Interval |
|---------------------------------|---------|--------------|----------|-------------------------|
| Relative Sensitivity (Past) | = | 28/41 | = 68.3% | 51.9 – 81.9% |
| Relative Specificity (Negative) | = | 242/256 | = 94.5% | 91.0 – 97.0% |
| Relative Agreement | = | 45/45 | = 100.0% | 92.1 – 100.0% |
| 315/342 | = 92.1% | 88.7 – 94.7% | | |
#### 95% Confidence Interval
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# TABLE 2 EBV STATUS VERSUS DIASORIN ELISA
| | PANBIO ELISA | | |
|--------------------------------------------------------------|--------------|----------|-------|
| EBV Status | Positive | Negative | Total |
| Seronegative<br>VCA IgG (-)<br>VCA IgM (-)<br>EBNA IgG (-) | 0 | 45 | 45 |
| Acute<br>VCA IgM (+)<br>EBNA IgG (-) | 35 | 6 | 41 |
| Past Infection<br>VCA IgG (+)<br>VCA IgM (-)<br>EBNA IgG (+) | 248 | 8 | 256 |
| Total | 283 | 59 | 342 |
Relative Sensitivity (Acute) Relative Sensitivity (Past) Relative Specificity (Negative) Relative Agreement
95% Confidence Interval = 85.4% = 35/41 70.8 – 94.4% = 248/256 = 96.9% 93.9 -- 98.6%
| = 45/45 | = 100.0% | 92.1 - 100.0% |
|-----------|----------|---------------|
| = 328/342 | = 95.6% | 93.2 - 97.7% |
| TABLE 3 | | | | |
|------------------------------|--|--|--|--|
| PANBIO VERSUS DIASORIN ELISA | | | | |
| PANBIO ELISA | | | |
|--------------|----------|----------|-------|
| DiaSorin | Positive | Negative | Total |
| Positive | 269 | 14 | 283 |
| Negative | 1 | 58 | 59 |
| Total | 270 | 72 | 342 |
| | | | 95% Confidence Interval |
|----------------------|-----------|---------|-------------------------|
| Relative Sensitivity | = 269/283 | = 95.1% | 91.8 – 97.3% |
| Relative Specificity | = 58/59 | = 98.3% | 90.9 – 100.0% |
| Relative Agreement | = 327/342 | = 95.6% | 92.9 – 97.5% |
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Image /page/3/Picture/0 description: The image shows the word "PANBIO" in bold, black letters. To the left of the word is a circular graphic with a stylized design. The design appears to be made up of intersecting lines or shapes, creating a textured effect within the circle.
## Study Site 3:
148 frozen retrospective sera of various ages and genders were submitted to a state health laboratory in Maryland USA for EBV testing. The sera include samples from the following groups: 25 seroneqative samples from patients with acute Infectious Mononucleosis, and 100 samples from patients with past exposure to EBV.
These sera were tested on the PANBIO EBV VCA-p18 IgG ELISA and the DiaSorin EBV VCA IgG ELISA. The PANBIO results were compared to the EBV status of the sera to determine the sensitivity, specificity, and agreement of the assay relative to the EBV serological status (Table 4). Additionally, the DiaSorin results were compared to the EBV serological status (Table 5) and PANBIO results (Table 6), as summarised below.
| EBV Status | Positive | Equivocal* | Negative | Total |
|--------------------------------------------------------------|----------|------------|----------|-------|
| Seronegative<br>VCA IgG (-)<br>VCA IgM (-)<br>EBNA IgG (-) | 0 | 1 | 24 | 25 |
| Acute<br>VCA IgM (+)<br>EBNA IgG (-) | 17 | 1 | 5 | 23 |
| Past Infection<br>VCA IgG (+)<br>VCA IgM (-)<br>EBNA IgG (+) | 100 | 0 | 0 | 100 |
| Total | 117 | 2 | 29 | 148 |
# TABLE 4 EBV STATUS VERSUS PANBIO ELISA PANBIO ELISA
#### 95% Confidence Interval
| Relative Sensitivity (Acute) | = 17/23 | = 73.9% | 51.6 - 89.8% |
|---------------------------------|-----------|----------|--------------|
| Relative Sensitivity (Past) | = 100/100 | = 100.0% | 96.4 - 100% |
| Relative Specificity (Negative) | = 24/25 | = 96.0% | 79.6 - 99.9% |
| Relative Agreement | = 141/148 | = 95.3% | 90.5 - 98.1% |
*Retesting of equivocal samples was not conducted, as the samples were unavailable.
Note: "Serological" sensitivity and specificity refers to the comparison of the PANBIO assay results to that of other assays normally used to diagnose EBV associated IM. There was not an attempt to correlate the assay's results with disease presence or absence. No judgement can be made on the comparison's accuracy to predict disease. Since the above studies were performed on a pre-selected, retrospective, populations for the assay's positive and negative predictive value may be done or inferred.
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Image /page/4/Picture/0 description: The image shows the word "PANBIO" in bold, black letters. To the left of the word is a circular graphic with a black, abstract design. The design appears to be two intertwined shapes, possibly letters, with a textured, almost distressed look. The overall impression is a logo or branding element for a company or product named Panbio.
| | TABLE 5 | | |
|--|---------|----------------------------------|--|
| | | EBV STATUS VERSUS DIASORIN ELISA | |
| EBV Status | Positive | Negative | Total |
|--------------------------------------------------------------|----------|----------|-------|
| Seronegative<br>VCA IgG (-)<br>VCA IgM (-)<br>EBNA IgG (-) | 2 | 23 | 25 |
| Acute<br>VCA IgM (+)<br>EBNA IgG (-) | 23 | 0 | 23 |
| Past Infection<br>VCA IgG (+)<br>VCA IgM (-)<br>EBNA IgG (+) | 100 | 0 | 100 |
| Total | 125 | 23 | 148 |
| | | 95% Confidence Interval |
|---------------------------------|--------------------|-------------------------|
| Relative Sensitivity (Acute) | = 23/23 = 100.0% | 85.2 – 100% |
| Relative Sensitivity (Past) | = 100/100 = 100.0% | 96.4 – 100% |
| Relative Specificity (Negative) | = 23/25 = 92.0% | 74.0 - 99.0% |
| Relative Agreement | = 146/148 = 98.6% | 95.2 - 99.8% |
# TABLE 6 PANBIO VERSUS DIASORIN ELISA
| DiaSorin | Positive | Equivocal* | Negative | Total |
|----------|----------|------------|----------|-------|
| Positive | 117 | 1 | 7 | 125 |
| Negative | 0 | 1 | 22 | 23 |
| Total | 117 | 2 | 29 | 148 |
| | | | 95% Confidence Interval |
|----------------------|-----------|---------|-------------------------|
| Relative Sensitivity | = 117/125 | = 93.6% | 87.8 – 97.2% |
| Relative Specificity | = 22/23 | = 95.7% | 78.0 – 99.9% |
| Relative Agreement | = 139/148 | = 93.9% | 88.8 - 97.2% |
*Retesting of equivocal samples was not conducted, as the samples were unavailable.
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Image /page/5/Picture/0 description: The image shows the word "PANBIO" in bold, black letters. To the left of the word is a circular graphic that appears to be a stylized representation of organic matter. The overall impression is that this is a logo or branding element for a company named Panbio, possibly related to biology or organic products.
### REPRODUCIBILITY
### Study Sites 1, 4 & 5:
The reproducibility of the PANBIO EBV VCA-p18 IgG ELISA was determined by testing 8 sera 3 times each on three different days at three Australian study sites. Two sites were private pathology laboratories and the third site was PANBIO Limited. Within-run, between day, between site and total precision were estimated by analysis of variance (ANOVA Type II). The results are presented in table 7 below.
# TABLE 7 PANBIO EBV VCA-p18 IgG Study
| | | Within | | Between Day | | Between Site | | Total | | |
|----------|----|--------|------|-------------|------|--------------|------|-------|------|-------|
| Sample | n | *Mean | *S.D | CV | *S.D | CV | *S.D | CV | *S.D | CV |
| Positive | 27 | 2.98 | 0.17 | 5.7% | 0.06 | 2.0% | 0.11 | 3.8% | 0.20 | 6.7% |
| Cut-off | 27 | 1.00 | 0.05 | 4.5% | 0.00 | 0.0% | 0.00 | 0.0% | 0.04 | 4.1% |
| Negative | 27 | 0.18 | 0.02 | 8.9% | 0.00 | 2.4% | 0.02 | 12.6% | 0.02 | 13.9% |
| #1 | 27 | 5.11 | 0.37 | 7.2% | 0.07 | 1.3% | 0.00 | 0.0% | 0.37 | 7.2% |
| #2 | 27 | 5.06 | 0.34 | 6.7% | 0.14 | 2.8% | 0.00 | 0.0% | 0.35 | 7.0% |
| #3 | 27 | 5.35 | 0.32 | 6.0% | 0.07 | 1.3% | 0.50 | 9.4% | 0.53 | 9.9% |
| #4 | 27 | 1.30 | 0.06 | 4.9% | 0.00 | 0.0% | 0.02 | 1.3% | 0.06 | 4.8% |
| #5 | 27 | 1.93 | 0.11 | 5.6% | 0.04 | 2.0% | 0.05 | 2.8% | 0.12 | 6.3% |
| #6 | 27 | 1.81 | 0.11 | 6.1% | 0.03 | 1.6% | 0.12 | 6.5% | 0.15 | 8.3% |
| #7 | 27 | 0.97 | 0.05 | 5.0% | 0.02 | 1.9% | 0.04 | 4.4% | 0.06 | 6.4% |
| #8 | 27 | 0.90 | 0.08 | 9.0% | 0.00 | 0.0% | 0.07 | 7.3% | 0.10 | 10.8% |
### Precision Measures (Using Cut-Off Ratio*)
All values are calculated from Ratios (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.
*Cut-off Ratio is calculated as the Absorbance of the Sample divided by the Mean Absorbance of the Cut-off.
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Image /page/6/Picture/0 description: The image shows the word "PANBIO" in bold, black letters. To the left of the word is a circular graphic that appears to be an abstract design. The graphic is also in black and white and has a textured appearance. The overall image is simple and clean, with a focus on the company name and logo.
### POTENTIAL CROSS-REACTIVITY
### Study Site 5:
This study consisted of a panel of 30 specimens screened for IgG antibodies detectable by ELISA to disease types other than Epstein-Barr virus. The purpose of this study was to establish the analytical specificity of the EBV VCA-p18 IgG 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 diagnosis and analysed with the EBV VCA-p18 IgG ELISA. Table 9 on the following page lists the crossreactivity results for each type of specimen included in the disease panel. Table 8 below provides a summary of the data presented in Table 9 (see next page).
| Disease<br>(IgG Antibodies) | Total Specimens | Positive Result |
|-----------------------------|-----------------|-----------------|
| Cytomegalovirus | 5 | (0/5) |
| Varicella zoster | 10 | (0/10) |
| Herpes simplex virus 1 | 8 | (1/8) |
| Herpes simplex virus 2 | 1 | (0/1) |
| Anti-Nuclear Antibody | 3 | (0/3) |
| Rheumatoid Factor | 3 | (0/3) |
| Total Antibody | 30 | (1/30) |
### TABLE 8 - PANBIO EBV VCA-p18 IgG CROSS-REACTIVITY SPECIMEN PANEL SUMMARY
Results indicate that one specimen (1/30) was positive when analysed with the EBV VCA-p18 IgG ELISA. The overall result of the above disease panel is consistent with good analytical specificity for the EBV VCA-p18 IgG ELISA.
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| | Gull IFA<br>Merifluor EBV IgG<br>Batch No. EB100.091 | PANBIO<br>EBV VCA-p18 IgG ELISA<br>Batch No. 02282 | Sample<br>IgG Antibodies | |
|----|------------------------------------------------------|----------------------------------------------------|--------------------------|-----------|
| 1 | N | 1.35 | N | CMV IgG |
| 2 | N | 1.82 | N | CMV IgG |
| 3 | N | 1.72 | N | CMV IgG |
| 4 | N | 3.56 | N | CMV IgG |
| 5 | N | 5.92 | N | CMV IgG |
| 6 | N | 3.56 | N | VZV IgG |
| 7 | N | 1.82 | N | VZV IgG |
| 8 | N | 1.18 | N | VZV IgG |
| 9 | N | 3.44 | N | VZV IgG |
| 10 | N | 1.35 | N | VZV IgG |
| 11 | N | 1.28 | N | VZV IgG |
| 12 | N | 5.92 | N | VZV IgG |
| 13 | N | 1.82 | N | VZV IgG |
| 14 | N | 1.60 | N | VZV IgG |
| 15 | N | 1.47 | N | VZV IgG |
| 16 | N | 3.56 | N | HSV 1 IgG |
| 17 | N | 1.97 | N | HSV 1 IgG |
| 18 | N | 5.92 | N | HSV 1 IgG |
| 19 | N | 1.47 | N | HSV 1 IgG |
| 20 | N | 1.28 | N | HSV 1 IgG |
| 21 | N | 1.60 | N | HSV 1 IgG |
| 22 | N | 2.04 | N | HSV 1 IgG |
| 23 | N | 13.73 | P | HSV 1 IgG |
| 24 | N | 5.70 | N | HSV 2 IgG |
| 25 | N | 0.75 | N | ANA |
| 26 | N | 0.73 | N | ANA |
| 27 | N | 0.84 | N | ANA |
| 28 | N | 0.58 | N | RF |
| 29 | N | 0.58 | N | RF |
| 30 | N | 0.67 | N | RF |
# TABLE 9 -- PANBIO EBV VCA-p18 IgG CROSS-REACTIVITY SPECIMEN PANEL
# INTERPRETATION
| | | -------<br>aunivoca | - |
|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|----------------|
| DANDIC | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | A CHARROOM CO | -------------- |
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#### METHODS OF DATA ANALYSIS 1.11
# Relative Sensitivity:
True Positives / (True Positives + False Negatives)
# Relative Specificity:
True Negatives / (True Negatives + False Positives)
# Relative Agreement:
(True Positives + True Negatives) / Total Samples
# 95% Confidence Interval:
CIA 'Confidence Interval Analysis' Software Program' from "Statistics with Confidence" by Prof. M. J. Gardner and British Medical Journal (1991). Version 1.1.
# ANOVA Analysis of Variance Type II:
Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline. NCCLS (1999), EP5-A Vol. 19 No. 2.
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Public Health Service
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 7 2003
Ms. Kate Wersin Regulatory Affairs Officer PANBIO Limited 116 Lutwyche Road, Windsor Brisbane, Queensland, 4030 Australia
Re: k030863
> Trade/Device Name: EBV VCA-p18 IgG ELISA Regulation Number: 21 CFR 866.3235 Regulation Name: Epstein-Barr Virus Serological Reagents Regulatory Class: Class I Product Code: LSE Dated: May 13, 2003 Received: May 16, 2003
Dear Ms. Wersin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Image /page/11/Picture/0 description: The image shows the word "PANBIO" in bold, black letters. To the left of the word is a circular graphic that is also in black. The graphic appears to be a stylized representation of some sort of organic material, possibly related to biology or nature, given the company name.
March 12, 2003
510(k) Number: K030863
# Device Name: EBV VCA-p18 IgG ELISA
The Epstein Barr Virus Viral Capsid-p18 Antigen (EBV VCA-p18) IgG ELISA Test is for the qualitative detection of IgG antibodies to EBV VCA in serum as an aid in the clinical laboratory diagnosis of EBV infection in patients with clinical symptoms consistent with Infectious Mononucleosis (IM). The PANBIO EBV VCA-p18 IgG ELISA should be used in conjunction with other EBV serologies.
# PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the Counter Use (Optional Format 1-2-96)
Freddie Tu-Poole
(Division Sign-Off) Division of Clinical La 510(k) Number
