Predicate Devices

DiaSorin EBV VCA IgG ELISA

Reference Devices

DiaSorin EBV VCA IgG ELISA

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard ELISA assay for detecting antibodies and does not mention any AI or ML components in the device description, performance studies, or key metrics.

Therapeutic

No
This device is an in-vitro diagnostic (IVD) test designed to detect antibodies to the Epstein-Barr virus, aiding in diagnosis rather than providing therapy.

Diagnostic

Yes

The intended use explicitly states the device 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)." This clearly indicates its role in aiding diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is an Enzyme Linked Immunosorbent Assay (ELISA), which is a laboratory-based test involving physical reagents and procedures, not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it is "for the qualitative detection of IgG antibodies to EBV VCA in serum as an aid in the clinical laboratory diagnosis of EBV infection". This clearly indicates it is used to test samples taken from the human body to provide information for diagnosis.
Device Description: The description confirms it is an "Enzyme Linked Immunosorbent Assay for the qualitative detection of IgG antibodies in human serum". This describes a laboratory test performed on a biological sample (human serum).
Intended User / Care Setting: The intended user is a "clinical laboratory", which is where IVD tests are typically performed.

These points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

LSE

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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 seronegative, 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.

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 seronegative 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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 seronegative, 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.

TABLE 1 EBV STATUS VERSUS PANBIO ELISA
Relative Sensitivity (Acute) = 28/41 = 68.3% (95% Confidence Interval: 51.9 – 81.9%)
Relative Sensitivity (Past) = 242/256 = 94.5% (95% Confidence Interval: 91.0 – 97.0%)
Relative Specificity (Negative) = 45/45 = 100.0% (95% Confidence Interval: 92.1 – 100.0%)
Relative Agreement = 315/342 = 92.1% (95% Confidence Interval: 88.7 – 94.7%)

TABLE 2 EBV STATUS VERSUS DIASORIN ELISA
Relative Sensitivity (Acute) = 35/41 = 85.4% (95% Confidence Interval: 70.8 – 94.4%)
Relative Sensitivity (Past) = 248/256 = 96.9% (95% Confidence Interval: 93.9 -- 98.6%)
Relative Specificity (Negative) = 45/45 = 100.0% (95% Confidence Interval: 92.1 - 100.0%)
Relative Agreement = 328/342 = 95.6% (95% Confidence Interval: 93.2 - 97.7%)

TABLE 3 PANBIO VERSUS DIASORIN ELISA
Relative Sensitivity = 269/283 = 95.1% (95% Confidence Interval: 91.8 – 97.3%)
Relative Specificity = 58/59 = 98.3% (95% Confidence Interval: 90.9 – 100.0%)
Relative Agreement = 327/342 = 95.6% (95% Confidence Interval: 92.9 – 97.5%)

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 seronegative 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.

TABLE 4 EBV STATUS VERSUS PANBIO ELISA
Relative Sensitivity (Acute) = 17/23 = 73.9% (95% Confidence Interval: 51.6 - 89.8%)
Relative Sensitivity (Past) = 100/100 = 100.0% (95% Confidence Interval: 96.4 - 100%)
Relative Specificity (Negative) = 24/25 = 96.0% (95% Confidence Interval: 79.6 - 99.9%)
Relative Agreement = 141/148 = 95.3% (95% Confidence Interval: 90.5 - 98.1%)

TABLE 5 EBV STATUS VERSUS DIASORIN ELISA
Relative Sensitivity (Acute) = 23/23 = 100.0% (95% Confidence Interval: 85.2 – 100%)
Relative Sensitivity (Past) = 100/100 = 100.0% (95% Confidence Interval: 96.4 – 100%)
Relative Specificity (Negative) = 23/25 = 92.0% (95% Confidence Interval: 74.0 - 99.0%)
Relative Agreement = 146/148 = 98.6% (95% Confidence Interval: 95.2 - 99.8%)

TABLE 6 PANBIO VERSUS DIASORIN ELISA
Relative Sensitivity = 117/125 = 93.6% (95% Confidence Interval: 87.8 – 97.2%)
Relative Specificity = 22/23 = 95.7% (95% Confidence Interval: 78.0 – 99.9%)
Relative Agreement = 139/148 = 93.9% (95% Confidence Interval: 88.8 - 97.2%)

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).

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 lists the cross-reactivity results for each type of specimen included in the disease panel. Table 8 provides a summary of the data presented in Table 9.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Relative Sensitivity, Relative Specificity, Relative Agreement.
Relative Sensitivity: True Positives / (True Positives + False Negatives)
Relative Specificity: True Negatives / (True Negatives + False Positives)
Relative Agreement: (True Positives + True Negatives) / Total Samples

Predicate Device(s)

DiaSorin EBV VCA IgG ELISA

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

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
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.

1

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
VCA IgG (-)
VCA IgM (-)
EBNA IgG (-)	0	45	45
Acute
VCA IgM (+)
EBNA IgG (-)	28	13	41
Past Infection
VCA 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

2

Image /page/2/Picture/0 description: The image shows the word "PANBIO" in all capital letters. To the left of the word is a circular graphic with a design inside. The letters in the word are bold and black. The graphic is also black and white.

TABLE 2 EBV STATUS VERSUS DIASORIN ELISA

	PANBIO ELISA
EBV Status	Positive	Negative	Total
Seronegative
VCA IgG (-)
VCA IgM (-)
EBNA IgG (-)	0	45	45
Acute
VCA IgM (+)
EBNA IgG (-)	35	6	41
Past Infection
VCA 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%

3

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
VCA IgG (-)
VCA IgM (-)
EBNA IgG (-)	0	1	24	25
Acute
VCA IgM (+)
EBNA IgG (-)	17	1	5	23
Past Infection
VCA 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.

4

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
VCA IgG (-)
VCA IgM (-)
EBNA IgG (-)	2	23	25
Acute
VCA IgM (+)
EBNA IgG (-)	23	0	23
Past Infection
VCA 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.

5

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.

6

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

(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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Image /page/7/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 have a textured or distressed effect, giving it a slightly rough or vintage look. The overall impression is of a company or brand with a strong, established presence.

| | Gull IFA
Merifluor EBV IgG
Batch No. EB100.091 | PANBIO
EBV VCA-p18 IgG ELISA
Batch No. 02282 | Sample
IgG Antibodies | |
|----|------------------------------------------------------|----- | 1 | N | 1.35 | 2 | N | 1.82 | 3 | N | 1.72 | 4 | N | 3.56 | 5 | N | 5.92 | 6 | N | 3.56 | 7 | N | 1.82 | 8 | N | 1.18 | 9 | N | 3.44 | 10 | N | 1.35 | 11 | N | 1.28 | 12 | N | 5.92 | 13 | N | 1.82 | 14 | N | 1.60 | 15 | N | 1.47 | 16 | N | 3.56 | 17 | N | 1.97 | 18 | N | 5.92 | 19 | N | 1.47 | 20 | N | 1.28 | 21 | N | 1.60 | 22 | N | 2.04 | 23 | N | 13.73 | 24 | N | 5.70 | 25 | N | 0.75 | 26 | N | 0.73 | 27 | N | 0.84 | 28 | N | 0.58 | 29 | N | 0.58 | 30 | N | 0.67 -----------------------------------------------|--------------------------|-----------|
| N | CMV IgG |
| N | CMV IgG |
| N | CMV IgG |
| N | CMV IgG |
| N | CMV IgG |
| N | VZV IgG |
| N | VZV IgG |
| N | VZV IgG |
| N | VZV IgG |
| N | VZV IgG |
| N | VZV IgG |
| N | VZV IgG |
| N | VZV IgG |
| N | VZV IgG |
| N | VZV IgG |
| N | HSV 1 IgG |
| N | HSV 1 IgG |
| N | HSV 1 IgG |
| N | HSV 1 IgG |
| N | HSV 1 IgG |
| N | HSV 1 IgG |
| N | HSV 1 IgG |
| P | HSV 1 IgG |
| N | HSV 2 IgG |
| N | ANA |
| N | ANA |
| N | ANA |
| N | RF |
| N | RF |
| N | RF |

TABLE 9 -- PANBIO EBV VCA-p18 IgG CROSS-REACTIVITY SPECIMEN PANEL

INTERPRETATION

| | | -------
aunivoca | - |
|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|----------------|
| DANDIC | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | A CHARROOM CO | -------------- |

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Image /page/8/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 design that appears to be abstract. The logo is also in black and has a distressed or textured appearance. The overall image has a clean, minimalist aesthetic.

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.

9

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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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