(101 days)
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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.
No
The device is an in vitro diagnostic (IVD) test used for the qualitative detection of antibodies to aid in the diagnosis of Epstein Barr virus infection; it does not provide therapy.
Yes
Explanation: The "Intended Use" section states that the device is "an aid in the clinical laboratory diagnosis of Epstein barr virus (EBV) infection". This indicates its purpose is to diagnose.
No
The device description explicitly states it is an "EBV-EBNA IgG ELISA Kit," which is a laboratory assay involving physical reagents and procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of IgG antibodies to EBNA in serum as an aid in the clinical laboratory diagnosis of Epstein barr virus (EBV) infection". This clearly indicates it's used to test a sample taken from the human body (serum) to provide information for a medical diagnosis.
- Device Description: It's described as an "enzyme-linked immunosorbent assay (ELISA) for the detection of IgG antibodies to EBV-EBNA antigen in human serum". This confirms it's a test performed on a biological sample (human serum) to detect a specific substance (antibodies).
- Intended User / Care Setting: The intended user is a "clinical laboratory", which is where IVD tests are typically performed.
- Performance Studies: The document details performance studies using human serum samples to evaluate the device's sensitivity, specificity, and agreement in diagnosing EBV infection. This is standard for demonstrating the clinical utility of an IVD.
All these factors align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility of tissues or organs, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Epstein Barr Virus Nuclear Antigen (EBNA) IgG ELISA Test is for the qualitative detection of IgG antibodies to EBNA in serum as an aid in the clinical laboratory diagnosis of Epstein barr virus (EBV) infection in patients with clinical symptoms consistent with infectious mononucleosis (IM). The PANBIO EBNA IgG ELISA should be used in conjunction with other EBV serologies.
Product codes (comma separated list FDA assigned to the subject device)
GNP
Device Description
The EBV-EBNA IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG antibodies to EBV-EBNA antigen in human serum.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratory / Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Study Site 2: 156 frozen retrospective sera of various ages and genders were submitted to a state health laboratory in Maryland USA for EBV testing. The sera include the following groups: 28 seronegative samples from patients with acute Infectious Mononucleosis, and 102 samples from patients with past exposure to EBV. These sera were tested on the PANBIO EBV-EBNA IgG kit and EBV ELISA assays from an alternate manufacturer to determine the EBV status of the sera.
Study Site 3: 352 prospective sera of various ages and genders were submitted to a private pathology laboratory in Queensland Australia for EBV testing. The sera include the following groups: 48 seronegative samples, 42 samples from patients with acute Infectious Mononucleosis, and 262 samples from patients with past exposure to EBV. These sera were tested on the PANBIO EBV-EBNA IgG kit and EBV ELISA assays from an alternate manufacturer to determine the EBV status of the sera.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Serological Sensitivity and Specificity
Study Site 2:
- Sample Size: 156 frozen retrospective sera
- Key Results:
- Serological Sensitivity (Past) = 99/102 = 97.1% (95% Confidence Interval: 91.6 - 99.4%)
- Serological Specificity (Acute) = 24/26 = 92.3% (95% Confidence Interval: 74.9-99.1%)
- Serological Specificity (Negative) = 27/28 = 96.4% (95% Confidence Interval: 81.6-99.9%)
- Serological Agreement = 150/156 = 96.2% (95% Confidence Interval: 91.8 - 98.6%)
Study Site 3:
- Sample Size: 352 prospective sera
- Key Results:
- Serological Sensitivity (Past) = 223/262 = 85.1% (95% Confidence Interval: 80.8 - 89.4%)
- Serological Specificity (Acute) = 42/42 = 100.0% (95% Confidence Interval: 91.6 - 100.0%)
- Serological Specificity (Negative) = 48/48 = 100.0% (95% Confidence Interval: 92.6 - 100.0%)
- Serological Agreement = 313/352 = 88.9% (95% Confidence Interval: 85.6 - 92.2%)
Reproducibility:
- Study Type: Reproducibility study
- Sample Size: 8 sera tested 3 times each on three different days at three Australian study sites (private pathology laboratories and PANBIO).
- Key Results: Measures of Within-run, Between Day, Between Site, and Total precision (Standard Deviation and Coefficient of Variation) were provided for positive, cut-off, negative, and 8 individual samples.
Potential Cross-Reactivity:
- Study Type: Analytical specificity study
- Sample Size: A panel of 32 specimens from patients with confirmed diseases other than Epstein Barr Virus (Cytomegalovirus (9), Varicella zoster (6), Herpes simplex virus 1 (6), Herpes simplex virus 2 (1), Anti-Nuclear Antigen (5), Rheumatoid Factor (5)).
- Key Results: 0/32 specimens were positive, indicating a true negative result of 100%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Study Site 2:
- Serological Sensitivity (Past) = 97.1%
- Serological Specificity (Acute) = 92.3%
- Serological Specificity (Negative) = 96.4%
- Serological Agreement = 96.2%
Study Site 3:
- Serological Sensitivity (Past) = 85.1%
- Serological Specificity (Acute) = 100.0%
- Serological Specificity (Negative) = 100.0%
- Serological Agreement = 88.9%
Reproducibility:
Coefficient of Variation (CV) ranged from:
- Within: 4.4% to 11.1%
- Between Day: 0.0% to 7.2%
- Between Site: 0.0% to 33.1%
- Total: 4.7% to 28.8%
Potential Cross-Reactivity:
True negative result = 100% (0/32 positive specimens)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
JUN 1 3 2002
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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: K020707
Applicant Information:
| Date Prepared: | 07th June, 2002 |
|---|---|
| Name: | PANBIO Limited |
| Address: | 116 Lutwyche Road |
| Windsor 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-EBNA IgG ELISA Kit |
|---|---|
| Common Name. | EBV-EBNA IgG EIA Test |
| Classification Name: | EBV-EBNA IgG Serological Reagent |
Equivalent Device:
Incstar EBV-EBNA IgG ELISA
Device Description:
The EBV-EBNA IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG antibodies to EBV-EBNA antigen in human serum.
Intended Use:
The Epstein Barr Virus Nuclear Antigen (EBNA) IgG ELISA Test is for the qualitative detection of IgG antibodies to EBNA in serum as an aid in the clinical laboratory diagnosis of Epstein barr virus (EBV) infection in patients with clinical symptoms consistent with infectious mononucleosis (IM). The PANBIO EBNA IgG ELISA should be used in conjunction with other EBV serologies.
Principle of Procedure:
Serum containing antibodies to EBNA-1 IgG, when present, combine with E.coli expressed EBNA-1 recombinant antigen attached to the polystyrene surface of the microwells. Residual serum is removed by washing and peroxidase conjugated anti-human IgG is added. The microwells are washed and a colourless substrate system, tetramethylbenzidine/hydrogen peroxide (TMB/H/O2) 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. Color development is indicative of the presence of EBNA IgG antibodies in the test sample.
1
PERFORMANCE CHARACTERISTICS
Study Site 2:
156 frozen retrospective sera of various ages and genders were submitted to a state health laboratory in Maryland USA for EBV testing. The sera include the following groups: 28 seronegative samples from patients with acute Infectious Mononucleosis, and 102 samples from patients with past exposure to EBV. These sera were tested on the PANBIO EBV-EBNA IgG kit and EBV ELISA assays from an alternate manufacturer to determine the EBV status of the sera. The PANBIO EBNA IgG results were compared to the EBV status of the sera to determine the sensitivity, specificity, and agreement of the EBV serological status. The data is summarized in Table 1.
| PANBIO ELISA | |||||||
|---|---|---|---|---|---|---|---|
| EBV Status | Positive | Equivocal | Negative | Total | |||
| Seronegative | |||||||
| VCA IgG (-) | |||||||
| VCA IgM (-) | |||||||
| EBNA IgG (-) | 0 | 1 | 27 | 28 | |||
| Acute | |||||||
| VCA IgM (+) | |||||||
| EBNA IgG (-) | 1 | 1 | 24 | 26 | |||
| Past Infection | |||||||
| VCA IgG (+) | |||||||
| VCA IgM (-) | |||||||
| EBNA IgG (+) | 99 | 2 | 1 | 102 | |||
| TOTAL | 100 | 4 | 52 | 156 |
TABLE 1 EBV-EBNA IgG Serological Sensitivity and Specificity of PANBIO ELISA versus EBV Status
95% Confidence Interval Serological Sensitivity (Past) = 99/102 = 97.1% 91.6 - 99.4% Serological Specificity (Acute) = 24/26 = 92.3% 74.9-99.1% Serological Specificity (Negative) = 27/28 = 96.4% 81.6-99.9% Serological Agreement = 150/156 = 96.2% 91.8 - 98.6%
- Retesting of equivocal samples was not conducted, as the samples were unavailable.
Note: "Serological" sensitivity and specificity refers to the PANBIO assay results to that of other assays normally used to diagnose EBV associated with IM. There was not an attempt to correlate the assay's results with disease presence. No judgement can be made on the comparison's accuracy to predict disease. Since the above studies were performed on a pre-selected, retrospective, population, no calculations for the assay's positive and negative predictive value may be done or inferred.
2
Study Site 3:
352 prospective sera of various ages and genders were submitted to a private pathology laboratory in Queensland Australia for EBV testing. The sera include the following groups: 48 seronegative samples, 42 samples from patients with acute Infectious Mononucleosis, and 262 samples from patients with past exposure to EBV. These sera were tested on the PANBIO EBV-EBNA IgG kit and EBV ELISA assays from an alternate manufacturer to determine the EBV status of the sera. The PANBIO EBV EBNA IgG 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. The data is summarized in Table 2.
| PANBIO ELISA | ||||
|---|---|---|---|---|
| EBV Status | Positive | Equivocal* | Negative | Total |
| Seronegative | ||||
| VCA IgG (-) | ||||
| VCA IgM (-) | ||||
| EBNA IgG (-) | 0 | 0 | 48 | 48 |
| Acute | ||||
| VCA IgM (+) | ||||
| EBNA IgG (-) | 0 | 0 | 42 | 42 |
| Past Infection | ||||
| VCA IgG (+) | ||||
| VCA IgM (-) | ||||
| EBNA IgG (+) | 223 | 4 | 35 | 262 |
| Total | 223 | 4 | 125 | 352 |
| 95% Confidence Interval | ||||
| Serological Sensitivity (Past) | = 223/262 | = 85.1% | 80.8 - 89.4% | |
| Serological Specificity (Acute) | = 42/42 | = 100.0% | 91.6 - 100.0% | |
| Serological Specificity (Negative) | = 48/48 | = 100.0% | 92.6 - 100.0% | |
| Serological Agreement | = 313/352 | = 88.9% | 85.6 - 92.2% |
TABLE 2 EBV-EBNA IgG Serological Sensitivity and Specificity of PANBIO ELISA versus EBV Status
- These equivocal samples were not tested on an alternative method due to insufficient sample. Collection of a further sample was not possible.
3
REPRODUCIBILITY
The reproducibility of the PANBIO EBV-VCA IgG ELISA kit 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. Within-run, between day, between site and total precision were estimated by analysis of variance (ANOVA Type II) and are presented in table 3 below.
TABLE 3 REPRODUCIBILITY DATA PANBIO EBV-EBNA IgG Study Site 1,2 & 3 Precision Measures (Using Cut-Off Ratio)
| Sample | n | *Mean | Within | Between Day | Between Site | Total | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| *S.D | CV | *S.D | CV | *S.D | CV | *S.D | CV | |||
| Positive | 27 | 2.38 | 0.16 | 6.9% | 0.09 | 3.7% | 0.00 | 0.0% | 0.18 | 7.4% |
| Cut-off | 27 | 1.00 | 0.05 | 5.2% | 0.00 | 0.0% | 0.00 | 0.0% | 0.05 | 4.8% |
| Negative | 27 | 0.10 | 0.01 | 6.8% | 0.00 | 3.0% | 0.01 | 7.3% | 0.01 | 9.4% |
| #1 | 27 | 2.97 | 0.15 | 4.9% | 0.06 | 1.9% | 0.48 | 16.2% | 0.43 | 14.4% |
| #2 | 27 | 3.20 | 0.18 | 5.7% | 0.07 | 2.1% | 0.07 | 2.3% | 0.20 | 6.3% |
| #3 | 27 | 1.20 | 0.08 | 6.7% | 0.09 | 7.2% | 0.35 | 29.0% | 0.31 | 25.8% |
| #4 | 27 | 1.28 | 0.09 | 6.9% | 0.07 | 5.7% | 0.42 | 33.1% | 0.37 | 28.8% |
| #5 | 27 | 0.65 | 0.06 | 9.4% | 0.04 | 6.5% | 0.00 | 0.0% | 0.07 | 10.7% |
| #6 | 27 | 0.95 | 0.06 | 6.5% | 0.06 | 6.6% | 0.12 | 12.1% | 0.13 | 13.2% |
| #7 | 27 | 3.45 | 0.15 | 4.4% | 0.09 | 2.6% | 0.00 | 0.0% | 0.16 | 4.7% |
| #8 | 27 | 1.37 | 0.15 | 11.1% | 0.09 | 6.8% | 0.08 | 5.8% | 0.18 | 13.3% |
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
4
POTENTIAL CROSS-REACTIVITY
Study Site 5:
A panel of 32 specimens from patients with confirmed diseases other than Epstein Barr Virus was tested to establish the analytical specificity of the EBV-EBNA IgG ELISA Test. The specimens were from patients with diseases that have the potential for cross-reactivity. Each of the specimens included in the study was characterized with respect to disease diagnosis prior to analysis with the EBV-EBNA IgG ELISA Test. Table 4 lists a summary of the results.
TABLE 4
| Disease Type | Number of Specimens | Result |
|---|---|---|
| Cytomegalovirus | 9 | (0/9) |
| Varicella zoster | 6 | (0/6) |
| Herpes simplex virus 1 | 6 | (0/6) |
| Herpes simplex virus 2 | 1 | (0/1) |
| Anti-Nuclear Antigen | 5 | (0/5) |
| Rheumatoid Factor | 5 | (0/5) |
| Total | 32 | (0/32) |
PANBIO EBV-EBNA IgG CROSS-REACTIVITY SPECIMEN PANEL
Results indicate that no specimens (0/32) were positive when analysed with the EBV-EBNA IgG ELISA Kit. Refer to 'Study Document - Site 5' for raw data and section 2.3.4.1 for the summary table.
The true negative result of 100% for the above disease panel is consistent with good analytical specificity for the EBV-EBNA IgG ELISA Test.
The PANBIO assay employs an E. coli expressed EBNA-1 protein. The cross-reactivity or interference of human anti-E. coli antibodies is unknown with the assay's results.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem that resembles a stylized eagle or bird with three wavy lines extending from its head. The logo is black and white.
JUN 1 3 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Helen Jennings Ouality and Regulatory Affairs Manager PANBIO Limited 116 Lutwyche Road Windsor, Brisbane Queensland, 4030 Australia
Re: K020707
Trade/Device Name: Epstein Barr Nuclear Antigen IgG ELISA Test Regulation Number: 21 CFR 866.3235 Regulation Name: Epstein - Barr virus Serological Reagents Regulatory Class: Class I Product Code: GNP Dated: May 9, 2002 Received: May 15, 2002
Dear Ms. Jennings:
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 the Code of Federal Regulations. Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Page 1
510(k) Number (if known): K020707
Device Name: EBV-EBNA IgG ELISA
Indications For Use: The Epstein Barr Virus Nuclear Antigen (EBNA) IgG ELISA Test is for the qualitative detection of IgG antibodies to EBNA in serum as an aid in the diagnosis of Epstein Barr (EBV) infection in patients with clinical symptoms of infectious mononucleosis (IM). The PANBIO EBNA 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)
Wooly Dubres
Timcal Laboratory Devices KD20 70 510(k) Number
PRESCRIPTION USE X
(Optional Format 3-10-98)