(218 days)
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No
The device description details a standard ELISA assay, which is a biochemical method for detecting antibodies. There is no mention of AI, ML, or any computational analysis beyond basic photometric measurement and calculation of standard metrics like sensitivity and specificity.
No
The device is an in vitro diagnostic (IVD) kit used to aid in the diagnosis of infectious mononucleosis by detecting antibodies, not to treat a condition.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device "may be used in conjunction with other Epstein-Barr serologies... as an aid in the diagnosis of infectious mononucleosis." This clearly indicates its role in diagnosing a medical condition.
No
The device description clearly outlines a physical ELISA kit involving 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 document explicitly states "For In Vitro Diagnostic Use Only." It also describes the device's use in testing human serum to aid in the diagnosis of infectious mononucleosis, which is a diagnostic purpose performed outside of the body (in vitro).
- Device Description: The description details an Enzyme-Linked Immunosorbent Assay (ELISA) that analyzes human serum to detect antibodies. This is a common method used in in vitro diagnostics.
- Performance Studies: The document includes performance characteristics like sensitivity, specificity, and precision, which are standard evaluations for IVD devices to demonstrate their analytical and clinical performance.
N/A
Intended Use / Indications for Use
The . Epstein-Barr Early Antigen Diffuse component (EA-D) IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to EA-D antigen. The Clark anti-EA-D IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EBNA-1 IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis.
Product codes
LSE
Device Description
Epstein-Barr Early Antigen Diffuse component (EA-D) IgG kit is an Enzyme-Linked The Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to EA-D antigen. The Clark anti-EA-D IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EBNA-1 IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis.
For In Vitro Diagnostic Use Only.
The EA-D IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Epstein-Barr Early Antigen Diffuse component. Purified recombinant EA-D 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 IgG 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
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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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Sensitivity and Specificity Based on Serum Characterization: One hundred and ninety three 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), early acute (VCA IgM and heterophile antibody present, EBNA IgG absent), late acute or transitional (VCA IgM, EBNA IgG and heterophile antibody present, approximately 4-12 weeks post infection), 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 EA-D IgG response should be negative for seronegative; early acute, and convalescent serum, and positive for transitional serum.
- Precision: Seven different sera were assayed ten times each on three different assays at three different sites to determine the precision of the assay.
- Cross-Reactivity: Serum containing IgG antibody detectable by ELISA to Herpes Simplex Virus I & II, Cytomegalovirus, and Varicella Zoster Virus were assayed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity (Late Acute) = 9/9 = 100% (95% Confidence Interval = 67.9%-100%)
Relative Specificity (Seronegative) = 14/14 = 100% (95% Confidence Interval = 79.1%-100%)
Relative Specificity (Early Acute) = 32/33 = 97.0% (95% Confidence Interval = 91.0%-100%)
Relative Sensitivity (Seropositive) = 26/132 = 19.7% (95% Confidence Interval = 12.8%-26.6%)
Relative Specificity (Seropositive) = 106/132 = 80.3% (95% Confidence Interval = 73.4%-87.2%)
Relative Agreement = 161/188 = 85.6% (95% Confidence Interval = 80.5%-90.8%)
Precision: SD and CV for 7 serum samples, HPC, CAL, LPC, NC.
Predicate Device(s)
EBV serology.
Reference Device(s)
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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
Summary of Safety and Effectiveness Information EA-D IgG ELISA Test Kit
I. Immuno Probe Inc. 1306 Bailes Lane, Suite F Frederick, Maryland 21701 Contact person: William Boteler Telephone: 301-695-7920 Date of preparation: Jan 7, 1998
II. Description of Device
Epstein-Barr Early Antigen Diffuse component (EA-D) IgG kit is an Enzyme-Linked The Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to EA-D antigen. The Clark anti-EA-D IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EBNA-1 IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis.
For In Vitro Diagnostic Use Only.
The EA-D IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Epstein-Barr Early Antigen Diffuse component. Purified recombinant EA-D 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 IgG 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 EA-D IgG 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 ninety three 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), early acute (VCA IgM and heterophile antibody present, EBNA IgG absent), late acute or transitional (VCA IgM, EBNA IgG and heterophile antibody present, approximately 4-12 weeks post infection), 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 EA-D IgG response should be negative for seronegative; early acute, and convalescent serum, and positive for transitional serum. The results are summarized in Table 1.
Table 1
| | | Early
Acute
VCA IgM+
EBNA IgG -
Heterophile + | Late
Acute
VCA IgM+
EBNA IgG +
Heterophile + | Seropositive
VCA IgG+
EBNA IgG+
VCA IgM-
Heterophile - | Seronegative
VCA IgG-
EBNA IgG -
VCA IgM -
Heterophile - |
|-------------------------------------|-----------|-----------------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------------------|----------------------------------------------------------------------|
| | Positive | 1 | 9 | 26 | 0 |
| Clark
EA-D IgG | Equivocal | 1 | 0 | 3 | 1 |
| | Negative | 32 | 0 | 106 | 14 |
| | Total | 34 | 9 | 135 | 15 |
| Relative Sensitivity (Late Acute) | | = 9/9 | = 100% | 95% Confidence Interval = 67.9%-100%* | |
| Relative Specificity (Seronegative) | | = 14/14 | = 100% | 95% Confidence Interval = 79.1%-100%* | |
| Relative Specificity (Early Acute) | | = 32/33 | = 97.0% | 95% Confidence Interval = 91.0%-100% | |
| Relative Sensitivity (Seropositive) | | = 26/132 | = 19.7% | 95% Confidence Interval = 12.8%-26.6% | |
| Relative Specificity (Seropositive) | | = 106/132 | = 80.3% | 95% Confidence Interval = 73.4%-87.2% | |
| Relative Agreement | | = 161/188 | = 85.6% | 95% Confidence Interval = 80.5%-90.8% | |
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 result.
2
Seven different sera were assayed ten times each on three different assays at three 2. Precision. different sites to determine the precision of the assay. The data from this study is presented in Table 2.
Table 2 EA-D IgG ELISA Inter-Site Precision Data
| (n = 90) | |||
|---|---|---|---|
| Serum # | X | S.D. | C.V. |
| 1 | 1.43 | 0.126 | 8.83% |
| 2 | 1.29 | 0.100 | 7.73% |
| 3 | 2.14 | 0.128 | 5.96% |
| 4 | 2.12 | 0.124 | 5.85% |
| 5 | 0.96 | 0.085 | 8.84% |
| 6 | 0.31 | 0.035 | 11.35% |
| 7 | 0.24 | 0.040 | 16.34% |
| HPC (n=9) | 2.86 | 0.062 | 2.18% |
| CAL (n=27) | 2.22 | 0.074 | 3.32% |
| LPC (n=9) | 1.79 | 0.082 | 4.59% |
| NC (n=9) | 0.01 | 0.012 | 154.52% |
Serum #5 was the only serum to change status. It was equivocal 66 times, negative 21 times, and positive 3 times.
X = Mean ISR parameters. SD = Standard Deviation CV = Coefficient of Variation The methods in NCCLS EP5 were utilized for precision
3
Serum containing IgG antibody detectable by ELISA to Herpes Simplex Virus I 3. Cross-Reactivity. & II, Cytomegalovirus, and Varicella Zoster Virus were assayed. The data summarized in Table 3 indicates that antibodies to these Herpes Viruses do not cross-react with the EA-D IgG EIA kit.
Table 3 EA-D Cross-Reactive Sera
| Serum | EA-D IgG | Alternate Assay |
|---|---|---|
| 1 | 0.26 | 3.59 (VZV IgG) |
| 2 | 0.83 | 7.58 (VZV IgG) |
| 3 | 0.45 | 2.17 (VZV IgG) |
| 4 | 0.40 | 2.77 (VZV IgG) |
| 5 | 0.74 | 3.95 (CMV IgG) |
| 6 | 0.54 | 2.44 (CMV IgG) |
| 7 | 0.31 | 1.57 (CMV IgG) |
| 8 | 0.37 | 3.45 (HSV 1 IgG) |
| 9 | 0.53 | 3.51 (HSV 1 IgG) |
| 10 | 0.56 | 3.70 (HSV 1 IgG) |
| 11 | 0.38 | 3.57 (HSV 2 IgG) |
| 12 | 0.64 | 3.58 (HSV 2 IgG) |
Sera ≥ 1.10 were considered positive. Sera ≤ 0.90 were considered negative.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures, represented by flowing lines, suggesting unity and collaboration.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 6 1998
Clark Laboratories, Inc c/o Mr. William L. Boteler Immuno Probe, Inc. 1306F Bailes Lane Frederick, Maryland 21701
K973123 Re: Trade Name: EA-D IgG ELISA Regulatory Class: I Product Code: LSE Dated: January 7, 1998 Received: January 12, 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 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 QS 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.
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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 Autman
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 1
510(k) Number: K973123
Device Name: EA-D IgG ELISA
Indications For Use: The . Epstein-Barr Early Antigen Diffuse component (EA-D) IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to EA-D antigen. The Clark anti-EA-D IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EBNA-1 IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis.
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)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K973/23