(73 days)
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No
The device description details a standard ELISA assay which relies on chemical reactions and photometric measurement, with no mention of AI or ML in the process or analysis.
No
This device is an in vitro diagnostic (IVD) test used to detect antibodies for diagnostic purposes, not to treat or prevent a disease.
Yes
The device is described as an "aid in the diagnosis of infectious mononucleosis," which directly indicates its use for diagnostic purposes. Additionally, the phrase "For In Vitro Diagnostic Use Only" further confirms its diagnostic nature.
No
The device description clearly outlines a laboratory-based Enzyme-Linked Immunosorbent Assay (ELISA) kit, which involves physical reagents, microtiter wells, and photometric measurement, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the kit is "for the qualitative determination of IgM antibodies in human serum to EBNA-1 antigen" and is used "as an aid in the diagnosis of infectious mononucleosis in adult populations." This clearly indicates the device is intended for use on biological specimens (human serum) to provide information for diagnostic purposes.
- Device Description: The description reiterates the intended use and explicitly states "For In Vitro Diagnostic Use Only."
- Mechanism: The description details an ELISA method, which is a common technique used in in vitro diagnostics to detect the presence of specific antibodies in a sample.
- Performance Studies: The document includes performance characteristics like sensitivity, specificity, and precision, which are standard metrics evaluated for IVD devices to demonstrate their analytical and clinical performance.
- Predicate Device: The mention of "EBV serology" as a predicate device further supports its classification as an IVD, as predicate devices are typically other legally marketed IVDs.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Wampole Epstein-Barr Virus Nuclear Antigen 1 (EBNA-1) IgM kit is an Enzyme-Linked Immunosorbent Assays (ELISA) for the qualitative determination of IgM antibodies in human serum to EBNA-1 antigen. The Wampole anti-EBNA-1 IgM assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EA-D IgG, EBNA-1 IgG and heterophile) as an aid in the diagnosis of infectious mononucleosis.
For In Vitro Diagnostic Use Only.
Product codes
LLM
Device Description
The EBNA-1 IgM ELISA test is an enzyme linked immunosorbent assay to detect IgM antibodies to Epstein-Barr Nuclear Antigen -1. Recombinant EBNA-1 antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgM is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
Mentions image processing
Not Found
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
adult populations.
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
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Summary of Performance Studies
-
Sensitivity and Specificity Based on Serum Characterization:
- Study Type: Characterization of selected serum samples.
- Sample Size: One hundred and sixty six selected serum samples.
- Data Source: Tested at a clinical lab.
- Annotation Protocol: Serum characterized as seronegative (no serological evidence of past or present EBV infection), acute (VCA IgM and heterophile antibody present, EBNA IgG absent), or seropositive (presence of VCA IgG antibodies and EBNA IgG, no evidence of VCA IgM or heterophile antibody, indicative of past infection). It was assumed that the EBNA-1 IgM response should be negative for seronegative, and convalescent serum, and positive for acute serum.
- Key Results:
- Relative Sensitivity (Acute) = 19/37 = 51.4% (95% Confidence Interval = 34.9%-67.8%)
- Relative Specificity (Seronegative) = 28/28 = 100% (95% Confidence Interval = 89.4%-100%)
- Relative Specificity (Seropositive) = 86/91 = 94.5% (95% Confidence Interval = 89.7%-99.3%)
- Relative Agreement = 133/156 = 85.3% (95% Confidence Interval = 79.6%-90.9%)
- Equivocal results were not included in the calculations and were reported as equivocal.
-
Precision:
- Study Type: Evaluation of precision.
- Sample Size: Six sera tested six times each at site one and ten times each at the second site.
- Key Results: Inter Site Precision data provided with Mean ISR Value, Standard Deviation, and Coefficient of Variation for six serum samples, HPC, CAL, and NC.
-
Cross-Reactivity:
- Study Type: Evaluation of cross-reactivity.
- Samples: Sera containing IgM antibody to Herpes Simplex Virus I & II, Cytomegalovirus, and Varicella Zoster Virus were assayed. Sera containing rheumatoid factor (RF) were also assayed.
- Key Results: Antibodies to Varicella and sera containing RF do not cross-react with the EBNA-1 IgM EIA kit. Some cross-reactivity to Herpes Simplex Virus and to Cytomegalovirus was observed.
Key Metrics
Relative Sensitivity (Acute) = 51.4%
Relative Specificity (Seronegative) = 100%
Relative Specificity (Seropositive) = 94.5%
Relative Agreement = 85.3%
Coefficient of Variation for precision ranging from 4.45% to 181.66%
Predicate Device(s)
Not Found
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
Summary of Safety and Effectiveness Information EBNA-1 IgM ELISA Test Kit
1 1998 MAY
- I. Trinity Biotech US PO Box 1059 Jamestown, NY 14702-1059 Contact person: Ron Cruver Telephone: 716-483-3851 Date of preparation: Feb 11,1998
II. Description of Device
The Wampole Epstein-Barr Virus Nuclear Antigen 1 (EBNA-1) IgM kit is an Enzyme-Linked Immunosorbent Assays (ELISA) for the qualitative determination of IgM antibodies in human serum to EBNA-1 antigen. The Wampole anti-EBNA-1 IgM assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EA-D IgG, EBNA-1 IgG and heterophile) as an aid in the diagnosis of infectious mononucleosis.
For In Vitro Diagnostic Use Only.
The EBNA-1 IgM ELISA test is an enzyme linked immunosorbent assay to detect IgM antibodies to Epstein-Barr Nuclear Antigen -1. Recombinant EBNA-1 antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgM is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
III. Predicate Device
The EBNA-1 IgM ELISA test is substantially equivalent to EBV serology. Equivalence is demonstrated by the following comparative results:
1
Performance Characteristics
1. Sensitivity and Specificity Based on Serum Characterization
One hundred and sixty six selected serum were tested at a clinical lab. The serum from the study were characterized as seronegative ( no serological evidence of past or present EBV infection), acute (VCA IgM and heterophile antibody present, EBNA IgG absent), or seropositive (presence of VCA IgG antibodies and EBNA IgG, no evidence of VCA IgM or heterophile antibody, indicative of past infection). The sensitivity, specificity and agreement of the assay was determined based on this characterization. It was assumed that the EBNA-1 IgM response should be negative for seronegative, and convalescent serum, and positive for acute serum. The results are summarized in Table 1.
Table 1
| | | Acute
VCA IgM+
EBNA IgG -
Heterophile + | Seropositive
VCA IgG+
EBNA IgG+
VCA IgM-
Heterophile - | Seronegative
VCA IgG-
EBNA IgG -
VCA IgM -
Heterophile - |
|---------------------------------|----------|--------------------------------------------------|--------------------------------------------------------------------|----------------------------------------------------------------------|
| Wampole
EBNA-1 IgM Equivocal | Positive | 19 | 5 | 0 |
| | | 2 | 8 | 0 |
| | Negative | 18 | 86 | 28 |
| | Total | 39 | 99 | 28 |
| Relative Sensitivity (Acute) | = 19/37 = 51.4% | 95% Confidence Interval = 34.9%-67.8% |
|---|---|---|
| Relative Specificity (Seronegative) | = 28/28 = 100% | 95% Confidence Interval = 89.4%-100% |
| Relative Specificity (Seropositive) | = 86/91 = 94.5% | 95% Confidence Interval = 89.7%-99.3% |
| Relative Agreement | = 133/156 = 85.3% | 95% Confidence Interval = 79.6%-90.9% |
Equivocal results were not included in the calculations.
Equivocal results were not retested. They were reported as equivocal.
The 95% confidence intervals were calculated using the normal method.
*The 95% confidence interval was calculated assuming one false positive.
2
- Precision. The Wampole EBNA-1 IgM EIA was evaluated for precision by testing six sera six times each at site one and ten times each at the second site on three different days. The results are summarized in the table below.
Inter Site Precision Data
| Inter Site Precision (n=48) | |||
|---|---|---|---|
| Serum# | X | S.D. | C.V. |
| 1 | 1.87 | 0.161 | 8.60% |
| 2 | 1.56 | 0.166 | 10.63% |
| 3 | 2.38 | 0.156 | 6.57% |
| 4 | 1.30 | 0.132 | 10.18% |
| 5 | 0.47 | 0.050 | 10.52% |
| 6 | 0.19 | 0.051 | 26.36% |
| HPC* | 3.28 | 0.146 | 4.45% |
| CAL** | 2.22 | 0.144 | 6.48% |
| NC* | 0.01 | 0.012 | 181.66% |
X = Mean ISR Value S.D. = Standard Deviation C.V. = Coefficient of Variation
- HPC and NC - n=6 ** CAL - n=18
3
- Cross-Reactivity. Sera containing IgM antibody detectable by ELISA to Herpes Simplex Virus I & II, Cytomegalovirus, and Varicella Zoster Virus were assayed. Sera containing rhuematoid factor (RF) were also assayed. The data summarized in Table 3 indicates that antibodies to Varicella and sera containing RF do not cross-react with the EBNA-1 IgM EIA kit. There is some cross reactivity to Herpes Simplex Virus and to Cytomegalovirus.
| Specificity | EBNA-1 IgM | Alternate Assay | |
|---|---|---|---|
| RF + | 0.15 | 1.87 | + |
| RF + | 0.09 | 1.82 | + |
| RF + | 0.01 | 1.73 | + |
| RF + | 0.10 | 1.80 | + |
| RF + | 0.10 | 1.85 | + |
| VZV M + | 0.44 | 3.28 | + |
| VZV M + | 0.17 | 5.46 | + |
| VZV M + | 0.10 | 4.98 | + |
| VZV M + | 0.29 | 2.34 | + |
| VZV M + | 0.20 | 2.18 | + |
| HSV 1 M + | 2.53 | 2.53 | + |
| HSV 1 M + | 0.27 | 1.65 | + |
| HSV 1 M + | 0.05 | 1.34 | + |
| HSV 1 M + | 0.08 | 1.32 | + |
| HSV 2 M + | 0.53 | 1.76 | + |
| HSV 2 M + | 0.08 | 1.60 | + |
| HSV 2 M + | 0.03 | 2.09 | + |
| HSV 2 M + | 0.62 | 1.96 | + |
| CMV M + | 1.57 | 1.23 | + |
| CMV M + | 0.98 | 1.92 | + |
| CMV M + | 2.00 | 3.83 | + |
| CMV M + | 0.38 | 1.32 | + |
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with its head turned to the left and its wings forming three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
1 1998 MAY
Clark Laboratories, Inc. c/o William L. Boteler, Jr. Immuno Probe, Inc. 1306 Bailes Lane, Suite F Frederick, Maryland 21701
K980598 Re: Trade Name: EBNA-1 IgM ELISA Regulatory Class: I Product Code: LLM Dated: February 13, 1998 Received: February 17, 1998
Dear Mr. Boteler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
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
6
Page 1 of 1
510(k) Number. Not Known
Device Name: EBNA-1 IgM ELISA
Indications For Use: The Epstein Barr Nuclear Antigen 1 (EBNA-1) IgM kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgM antibodies in human serum to EBNA-1 antigen. The Clark anti-EBNA-1 IgM assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EA-D IgG, EBNA-1 IgG and heterophile) as an aid in the diagnosis of infectious mononucleosis in adult populations.
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) --
Alo H
(Division Sign-Off) Division of Clinical Laboratory 510(k) Number_