(100 days)
DiaSorin Incstar EBV-VCA IgM ELISA
DiaSorin Incstar EBV-VCA IgM ELISA
No
The device description and performance studies describe a standard ELISA assay, which is a biochemical test, not a software-based AI/ML system. There are no mentions of AI, ML, or related terms.
No
The device is for the qualitative detection of IgM antibodies to EBV VCA in serum and is intended as an aid in diagnosis, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for the qualitative detection of IgM antibodies to EBV VCA in serum as an aid in the clinical laboratory diagnosis of EBV infection".
No
The device description clearly states it is an "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 is for the "qualitative detection of IgM antibodies to EBV VCA in serum as an aid in the clinical laboratory diagnosis of EBV infection". This clearly indicates it is used to examine specimens derived from the human body (serum) to provide information for the diagnosis of a disease (EBV infection).
- Device Description: The description confirms it is an "enzyme-linked immunosorbent assay (ELISA) for the detection of IgM antibodies to EBV-VCA antigen in human serum". This further reinforces its use in analyzing human biological samples.
- Intended User / Care Setting: The intended user is a "clinical laboratory", which is a typical setting for performing in vitro diagnostic tests.
These points align directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Epstein-Barr Viral Capsid Antigen (VCA) IgM ELISA Test is for the qualitative detection of IgM 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 IgM ELISA should be used in conjunction with other EBV serology.
Product codes
GNP
Device Description
The EBV-VCA IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgM antibodies to EBV-VCA antigen in human serum.
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
clinical laboratory
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 2:
156 frozen retrospective sera of various ages and genders were submitted to a state health lab in Maryland USA for EBV testing. The sera include samples from the following groups: 28 seronegative samples, 26 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-VCA IgM 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 Oueensland Australia for EBV testing. The sera include samples from 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-VCA IgM kit and EBV ELISA assays from an alternate manufacturer to determine the EBV status of the sera.
Cross-Reactivity Study (Study Site 5):
A panel of 50 specimens from patients with confirmed diseases other than Epstein Barr Virus was tested. 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-VCA IgM ELISA Test.
Summary of Performance Studies
Study Site 2:
Study type: Comparison of PANBIO EBV VCA IgM results to EBV status determined by an alternate manufacturer's EBV ELISA assays.
Sample size: 156 frozen retrospective sera.
Key results: Serological Sensitivity (Acute) = 100 % (95% CI: 86.8 – 100 %), Serological Sensitivity (Past) = 90.2 % (95% CI: 82.7 – 95.2 %), Serological Specificity (Negative) = 100% (95% CI: 87.7 – 100 %), Serological Agreement = 93.6 % (95% CI: 88.5 – 96.9 %).
Study Site 3:
Study type: Comparison of PANBIO EBV VCA IgM results to EBV status determined by an alternate manufacturer's EBV ELISA assays.
Sample size: 352 prospective sera.
Key results: Serological Sensitivity (Acute) = 85.7% (95% CI: 71.5 - 94.6%), Serological Specificity (Past) = 98.1% (95% CI: 95.6-99.4%), Serological Specificity (Negative) = 87.5% (95% CI: 74.7 - 95.3%), Serological Agreement = 95.2% (95% CI: 92.4 - 97.2%).
Reproducibility Study:
Study type: Reproducibility study testing 8 sera 3 times each on three different days at three Australian study sites (two private pathology laboratories and PANBIO).
Key results: Precision measures (using Cut-Off Ratio) for Within-run, Between Day, Between Site, and Total precision were estimated by ANOVA.
Positive sample: Total CV = 7.7%
Cut-off sample: Total CV = 4.8%
Negative sample: Total CV = 21.6%
Other samples (1-8) Total CVs ranged from 7.2% to 28.1%.
Potential Cross-Reactivity Study (Study Site 5):
Study type: Analytical specificity study using a panel of specimens from patients with confirmed diseases other than EBV.
Sample size: 50 specimens.
Key results: 0/50 specimens were positive when analyzed with the EBV-VCA IgM ELISA Kit, indicating 100% true negative result for the disease panel.
Key Metrics
Study Site 2:
Serological Sensitivity (Acute) = 26/26 = 100 %
Serological Sensitivity (Past) = 92/102 = 90.2 %
Serological Specificity (Negative) = 28/28 = 100%
Serological Agreement = 146/156 = 93.6 %
Study Site 3:
Serological Sensitivity (Acute) = 36/42 = 85.7%
Serological Specificity (Past) = 257/262 =98.1%
Serological Specificity (Negative) = 42/48 = 87.5%
Serological Agreement = 335/352 = 95.2%
Predicate Device(s)
DiaSorin Incstar EBV-VCA IgM ELISA
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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: K020717
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-VCA IgM ELISA Kit |
|---|---|
| Common Name. | EBV-VCA IgM EIA Test |
| Classification Name; | EBV-VCA IgM Serological Reagent |
Equivalent Device:
DiaSorin Incstar EBV-VCA IgM ELISA
Device Description:
The EBV-VCA IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgM antibodies to EBV-VCA antigen in human serum.
Intended Use:
The Epstein-Barr Viral Capsid Antigen (VCA) IgM ELISA Test is for the qualitative detection of IgM 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 IgM ELISA should be used in conjunction with other EBV serology.
Principle of Procedure:
Serum containing antibodies to VCA antigen, when present, combine with EBV-VCA antigen, which is immunopurified utilising a monoclonal specific for gp125 and attached to the polystyrene surface of the microwells. Residual serum is removed by washing and peroxidase conjugated anti-human IgM is added. The microwells are washed and a colourless substrate system, tetramethylbenzidine/ hydrogen peroxide (TMB/H2/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 EBV-VCA IgM antibodies in the test sample.
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PERFORMANCE CHARACTERISTICS
Study Site 2:
156 frozen retrospective sera of various ages and genders were submitted to a state health lab in Maryland USA for EBV testing. The sera include samples from the following groups: 28 seronegative samples, 26 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-VCA IgM kit and EBV ELISA assays from an alternate manufacturer to determine the EBV status of the sera. The PANBIO EBV VCA IgM 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 the Table 1.
TABLE 1 EBV VCA IgM Serological Sensitivity and Specificity of PANBIO ELISA versus EBV Status
| EBV Status | Positive | Equivocal* | Negative | Total |
|---|---|---|---|---|
| Seronegative | ||||
| VCA IgG (-) | ||||
| VCA IgM (-) | ||||
| EBNA IgG (-) | 0 | 0 | 28 | 28 |
| Acute | ||||
| VCA IgM (+) | ||||
| EBNA IgG (-) | 26 | 0 | 0 | 26 |
| Past Infection | ||||
| VCA IgG (+) | ||||
| VCA IgM (-) | ||||
| EBNA IgG (+) | 5 | 5 | 92 | 102 |
| Total | 31 | 5 | 120 | 156 |
PANBIO ELISA
95% Confidence Interval
| Serological Sensitivity (Acute) | = 26/26 | = 100 % | 86.8 – 100 % |
|---|---|---|---|
| Serological Sensitivity (Past) | = 92/102 | = 90.2 % | 82.7 – 95.2 % |
| Serological Specificity (Negative) | = 28/28 | = 100% | 87.7 – 100 % |
| Serological Agreement | = 146/156 | = 93.6 % | 88.5 – 96.9 % |
- 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 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.
2
Study Site 3:
352 prospective sera of various ages and genders were submitted to a private pathology laboratory in Oueensland Australia for EBV testing. The sera include samples from 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-VCA IgM kit and EBV ELISA assays from an alternate manufacturer to determine the EBV status of the PANBIO VCA IgM 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 (-) 5 l 42 48 VCA IgM (-) EBNA IgG (-) Acute 36 5 VCA IgM (+) 1 42 EBNA IgG (-) Past Infection VCA IgG (+) 5 0 257 262 VCA IgM (-) EBNA IgG (+) 2 Total 46 304 352 95% Confidence Interval Serological Sensitivity (Acute) = 36/42 = 85.7% 71.5 - 94.6% Serological Specificity (Past) = 257/262 =98.1% 95.6-99.4% Serological Specificity (Negative) = 42/48 74.7 - 95.3% = 87.5%
PANBIO ELISA
TABLE 2 EBV-VCA IgM 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.
= 95.2%
92.4 - 97.2%
= 335/352
Serological Agreement
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REPRODUCIBILITY
The reproducibility of the PANBIO EBV-VCA IgM 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-VCA IgM Study Site 1, 2 & 3 Precision Measures (Using Cut-Off Ratio)
| Within | Between Day | Between Site | Total | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Sample | n | *Mean | *S.D | CV | *S.D | CV | *S.D | CV | *S.D | CV |
| Positive | 27 | 2.38 | 0.17 | 6.9% | 0.09 | 3.9% | 0.01 | 0.4% | 0.18 | 7.7% |
| 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 | 0.02 | 15.5% | 0.02 | 15.5% | 0.01 | 9.4% | 0.02 | 21.6% |
| #1 | 27 | 2.97 | 0.19 | 6.3% | 0.23 | 7.8% | 0.13 | 4.2% | 0.29 | 9.7% |
| #2 | 27 | 3.20 | 0.19 | 5.9% | 0.19 | 6.0% | 0.06 | 1.9% | 0.25 | 7.9% |
| #3 | 27 | 1.20 | 0.13 | 10.5% | 0.13 | 10.9% | 0.00 | 0.0% | 0.16 | 13.6% |
| #4 | 27 | 1.28 | 0.06 | 5.0% | 0.05 | 3.9% | 0.06 | 4.8% | 0.09 | 7.2% |
| #5 | 27 | 0.65 | 0.12 | 18.3% | 0.05 | 8.1% | 0.01 | 1.5% | 0.13 | 19.5% |
| #6 | 27 | 0.95 | 0.08 | 8.8% | 0.06 | 6.3% | 0.00 | 0.0% | 0.10 | 10.1% |
| #7 | 27 | 3.45 | 0.24 | 7.1% | 0.32 | 9.1% | 0.00 | 0.0% | 0.35 | 10.2% |
| #8 | 27 | 1.37 | 0.27 | 19.8% | 0.31 | 22.8% | 0.10 | 7.4% | 0.38 | 28.1% |
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
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POTENTIAL CROSS-REACTIVITY
Study Site 5:
A panel of 50 specimens from patients with confirmed diseases other than Enstein Barr Virus was tested to establish the analytical specificity of the EBV-VCA IgM 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-VCA IgM ELISA Test. Table 4 lists a summary of the results.
TABLE 4
| Disease Type | Number of Specimens | Positive Result |
|---|---|---|
| Cytomegalovirus | 9 | (0/9) |
| Varicella zoster | 10 | (0/10) |
| Herpes simplex virus 1 & 2 | 8 | (0/8) |
| Anti-Nuclear Antigen | 14 | (0/14) |
| Rheumatoid Factor | 9 | (0/9) |
| Total | 50 | (0/50) |
PANBIO EBV-VCA IgM CROSS-REACTIVITY SPECIMEN PANEL
Results indicate that no specimens (0/50) were positive when analysed with the EBV-VCA IgM 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-VCA IgM ELISA Test.
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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: K020717
Trade/Device Name: EBV Viral Capsid Antigen IgM 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. Iisting 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.
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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 Gutman
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
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Page 1 of of 1
510(k) Number (if known): K020717
EBV-VCA IgM ELISA Device Name:
Indications For Use: The Epstein-Barr Viral Capsid Antigen (VCA) IgM ELISA Test is for the qualitative detection of IgM 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 IgM ELISA should be used in conjunction with other EBV serology.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubois
Chnical Laboratory Devices K020 717 510(k) Number .
PRESCRIPTION USE X
(Optional Format 3-10-98)