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.

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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the PANBIO EBV VCA-p18 IgG ELISA, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or agreement. Instead, it presents the performance characteristics as a comparison to an equivalent device (DiaSorin EBV VCA IgG ELISA) and established EBV serological status. The study aims to demonstrate that the device performs comparably and effectively identifies different EBV infection states.

However, based on the results and the context of a 510(k) submission, we can infer that the observed performance values for sensitivity, specificity, and agreement, particularly in relation to the predicate device and the known EBV status, were considered acceptable by the manufacturer for regulatory clearance.

Table of Reported Device Performance for PANBIO EBV VCA-p18 IgG ELISA (Study Site 1):

Performance Metric	EBV Status Category	Reported PANBIO Performance	95% Confidence Interval
Relative Sensitivity	Acute	68.3% (28/41)	51.9 – 81.9%
Relative Sensitivity	Past Infection	94.5% (242/256)	91.0 – 97.0%
Relative Specificity	Seronegative	100.0% (45/45)	92.1 – 100.0%
Relative Agreement	All	92.1% (315/342)	88.7 – 94.7%

Table of Reported Device Performance for PANBIO EBV VCA-p18 IgG ELISA (Study Site 3):

Performance Metric	EBV Status Category	Reported PANBIO Performance	95% Confidence Interval
Relative Sensitivity	Acute	73.9% (17/23)	51.6 - 89.8%
Relative Sensitivity	Past Infection	100.0% (100/100)	96.4 - 100%
Relative Specificity	Seronegative	96.0% (24/25)	79.6 - 99.9%
Relative Agreement	All	95.3% (141/148)	90.5 - 98.1%

2. Sample Sizes and Data Provenance

Study Site 1 (Primary Performance Study):

Sample Size (Test Set): 342 sera
- Seronegative: 45
- Acute IM: 41
- Past Exposure to EBV: 256
Data Provenance: Prospective sera collected from a private pathology laboratory in Queensland, Australia.

Study Site 3 (Confirmatory Performance Study):

Sample Size (Test Set): 148 sera
- Seronegative: 25
- Acute IM: 23
- Past Exposure to EBV: 100
Data Provenance: Frozen retrospective sera submitted to a state health laboratory in Maryland, USA.

3. Number of Experts and their Qualifications (for Ground Truth)

The document does not explicitly mention the use of "experts" for establishing the ground truth in the traditional sense of clinicians or radiologists reviewing cases. Instead, the ground truth for the EBV status of the test sets was established by the results of other standard EBV serological assays.

The "EBV Status" was defined based on a combination of different assay results:

Seronegative: VCA IgG (-), VCA IgM (-), EBNA IgG (-)
Acute IM: VCA IgM (+), EBNA IgG (-)
Past Infection: VCA IgG (+), VCA IgM (-), EBNA IgG (+)

This implies that the "experts" were the laboratory personnel and clinicians who interpreted these existing serological results to categorize the samples. No specific number or qualifications for individual experts interpreting these criteria are provided.

4. Adjudication Method

The document does not describe an adjudication method in the context of multiple expert readers. The ground truth was established by comparing the device's results to the serological EBV status determined by a panel of other EBV serologies. For the study at Site 3, it is noted that re-testing of equivocal samples was not conducted because the samples were unavailable. This suggests that there was no specific adjudication process for discordant results against the "EBV Status" ground truth, beyond the initial classification based on the serological panel.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the standalone performance of an in vitro diagnostic device (ELISA) against serological ground truth and a predicate device, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study (i.e., algorithm only without human-in-the-loop performance) was done. The PANBIO EBV VCA-p18 IgG ELISA is an automated/semi-automated test that provides a quantitative result (absorbance) which is then interpreted qualitatively (Positive/Negative/Equivocal) based on a cut-off ratio. The reported sensitivity, specificity, and agreement values are for the device itself.

7. Type of Ground Truth Used

The ground truth used was expert consensus derived from other EBV serological assays. The "EBV Status" for each sample was determined by a panel of a priori defined serological markers for VCA IgG, VCA IgM, and EBNA IgG, which are established indicators of different stages of EBV infection.

The study explicitly states: "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." This clarifies that the ground truth is based on laboratory-defined serological status, not direct clinical outcomes or pathology reports.

8. Sample Size for the Training Set

The document does not provide information about a distinct "training set." The studies described are performance evaluations of the finalized device (test sets). For an ELISA, development typically involves optimization using a set of samples, but these are not explicitly called out as a "training set" with specific numbers.

9. How Ground Truth for the Training Set Was Established

As no specific training set is detailed, information on how its ground truth was established is not provided. Typically, in the development of such assays, candidate samples would be characterized using established reference methods for the target analyte (EBV VCA IgG antibodies).

Summary

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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, WindsorQueensland 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:

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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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
SeronegativeVCA IgG (-)VCA IgM (-)EBNA IgG (-)	0	45	45
AcuteVCA IgM (+)EBNA IgG (-)	28	13	41
Past InfectionVCA IgG (+)VCA IgM (-)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
SeronegativeVCA IgG (-)VCA IgM (-)EBNA IgG (-)	0	45	45
AcuteVCA IgM (+)EBNA IgG (-)	35	6	41
Past InfectionVCA IgG (+)VCA IgM (-)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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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
SeronegativeVCA IgG (-)VCA IgM (-)EBNA IgG (-)	0	1	24	25
AcuteVCA IgM (+)EBNA IgG (-)	17	1	5	23
Past InfectionVCA IgG (+)VCA IgM (-)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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	TABLE 5
		EBV STATUS VERSUS DIASORIN ELISA

EBV Status	Positive	Negative	Total
SeronegativeVCA IgG (-)VCA IgM (-)EBNA IgG (-)	2	23	25
AcuteVCA IgM (+)EBNA IgG (-)	23	0	23
Past InfectionVCA IgG (+)VCA IgM (-)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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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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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(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 IFAMerifluor EBV IgGBatch No. EB100.091	PANBIOEBV VCA-p18 IgG ELISABatch No. 02282	SampleIgG 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

		-------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

Image /page/9/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the caduceus. The logo is black and white.

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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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)

Over-the Counter Use (Optional Format 1-2-96)

Freddie Tu-Poole

(Division Sign-Off) Division of Clinical La 510(k) Number

Regulation Number and Section

§ 866.3235 Epstein-Barr virus serological reagents.

(a)
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).(b)
Classification. Class I (general controls).