(134 days)
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No
The device description details a standard ELISA assay, which is a biochemical test. There is no mention of AI/ML in the device description, performance studies, or key metrics.
No
This device is an in vitro diagnostic (IVD) kit used for the qualitative determination of IgG antibodies, aiding in the diagnosis of infectious mononucleosis. It does not treat or prevent disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "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 diagnosis.
No
The device is an Enzyme-Linked Immunosorbent Assay (ELISA) kit, which is a laboratory test involving physical reagents and a microtiter plate, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the qualitative determination of IgG antibodies in human serum to VCA antigen" and "as an aid in the diagnosis of infectious mononucleosis in a adult population." This clearly indicates the device is intended to be used in vitro (outside the body) to examine specimens (human serum) for diagnostic purposes.
- Device Description: The description details an ELISA method using human serum, which is a common in vitro diagnostic technique. It also explicitly states "For In Vitro Diagnostic Use Only."
- Performance Studies: The performance studies involve testing human serum samples and evaluating metrics like sensitivity and specificity, which are standard for evaluating the performance of in vitro diagnostic tests.
The information provided strongly supports the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Epstein-Barr Viral Capsid Antigen (VCA) IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to VCA antigen. The Clark anti-VCA IgG assay may be used in conjunction with other Epstein-Barr serologies (EA-D 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.
Product codes (comma separated list FDA assigned to the subject device)
LSE
Device Description
The VCA IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Epstein-Barr Viral Capsid Antigen. Purified recombinant VCA 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
adult population.
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 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 VCA IgG response should be negative for seronegative, and positive for acute serum and convalescent serum.
- Precision: Six different sera were assayed ten times each on three different assays. The data from this study is presented in Table 2.
- Cross-Reactivity: Serum containing IgG antibody detectable by ELISA to Herpes Simplex Virus I & 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 VCA IgG EIA kit.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity (Acute) = 20/34 = 58.8% (95% Confidence Interval = 41.9%-75.7%)
Relative Sensitivity (Seropositive) = 94/99 = 95.0% (95% Confidence Interval = 90.5%-99.4%)
Relative Specificity (Seronegative) = 27/27 = 100% (95% Confidence Interval = 89.0%-100%)
Relative Agreement = 140/160 = 87.5% (95% Confidence Interval = 82.3%-92.7%)
Precision:
Serum 1: X = 4.37, SD = 0.341, CV = 7.80%
Serum 2: X = 1.80, SD = 0.203, CV = 11.33%
Serum 3: X = 3.47, SD = 0.289, CV = 8.33%
Serum 4: X = 3.31, SD = 0.442, CV = 13.32%
Serum 5: X = 0.35, SD = 0.083, CV = 23.48%
Serum 6: X = 0.28, SD = 0.072, CV = 26.16%
HP*: X = 7.22, SD = 0.663, CV = 9.19%
Cal**: X = 4.00, SD = 0.239, CV = 5.99%
LP*: X = 2.52, SD = 0.351, CV = 13.92%
NC*: X = 0.05, SD = 0.048, CV = 105.88%
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.
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Jul 22 1998
. P. i
Summary of Safety and Effectiveness Information VCA 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: March 2, 1998
II. Description of Device
The Epstein-Barr Viral Capsid Antigen (VCA) IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to VCA antigen. The Clark anti-VCA IgG assay may be used in conjunction with other Epstein-Barr serologies (EA-D 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 VCA IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Epstein-Barr Viral Capsid Antigen. Purified recombinant VCA 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 VCA 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 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 VCA IgG response should be negative for seronegative, and positive for acute serum and convalescent serum. The results are summarized in 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
VCA IgG | Positive | 20 | 94 | 0 |
| | Equivocal | 5 | 0 | 1 |
| | Negative | 14 | 5 | 27 |
| | Total | 39 | 99 | 28 |
| Relative Sensitivity (Acute) | | = 20/34 | = 58.8% | 95% Confidence Interval = 41.9%-75.7% |
| Relative Sensitivity (Seropositive) | | = 94/99 | = 95.0% | 95% Confidence Interval = 90.5%-99.4% |
| Relative Specificity (Seronegative) | | = 27/27 | = 100% | 95% Confidence Interval = 89.0%-100% |
| Relative Agreement | | = 140/160 | = 87.5% | 95% Confidence Interval = 82.3%-92.7% |
Table 1
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 Seronegative 95% Confidence Interval was calculated assuming one false positive.
2
Six different sera were assayed ten times each on three different assays at three 2. Precision. 2: 1 receision - Bin direction of the assay. The data from this study is presented in Table 2.
Table 2 VCA IgG ELISA Inter-Site Precision Data
n = 60
| Serum | X | SD | CV |
|---|---|---|---|
| 1 | 4.37 | 0.341 | 7.80% |
| 2 | 1.80 | 0.203 | 11.33% |
| 3 | 3.47 | 0.289 | 8.33% |
| 4 | 3.31 | 0.442 | 13.32% |
| 5 | 0.35 | 0.083 | 23.48% |
| 6 | 0.28 | 0.072 | 26.16% |
| HP* | 7.22 | 0.663 | 9.19% |
| Cal** | 4.00 | 0.239 | 5.99% |
| LP* | 2.52 | 0.351 | 13.92% |
| NC* | 0.05 | 0.048 | 105.88% |
- HP, LP and NC n = 12 ** Cal n = 18
The methods in NCCLS EP5 were utilized for precision
X = Mean ISR parameters. SD = Standard Deviation CV = Coefficient of Variation
3
- Cross-Reactivity. Serum containing IgG antibody detectable by ELISA to Herpes Simplex Virus I & 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 VCA IgG EIA kit.
Table 3 VCA Cross-Reactive Sera
| Serum | VCA IgG | Alternate Assay | |
|---|---|---|---|
| 1 | 0.19 | 1.71 | (VZV IgG) |
| 2 | 0.12 | 6.03 | (VZV IgG) |
| 3 | 0.13 | 4.27 | (VZV IgG) |
| 4 | 0.18 | 3.93 | (VZV IgG) |
| 5 | 0.20 | 2.29 | (CMV IgG) |
| 6 | 0.16 | 3.69 | (CMV IgG) |
| 7 | 0.30 | 3.53 | (HSV 1 IgG) |
| 8 | 0.61 | 3.26 | (HSV 2 IgG) |
Sera ≥ 1.10 were considered positive. Sera ≤ 0.90 were considered negative.
. ·
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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
JUL 221998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
CLARK LABORATORIES, INC. c/o William L. Boteler, Jr. IMMUNO PROBE, INC. 1306 Bailes Lane, Suite F Frederick, MD 21701
K980912 Re: Trade Name: VCA IgG ELISA Requlatory Class: II Product Code: LSE Dated: April 22, 1998 Received: April 30, 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 requirement, as set forth in the Quality System Regulation (QS) 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 Reqister. 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 requlation (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
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Page 1 of 1
510(k) Number: Not Known
ﻬﺎ ﻓﻬ
Device Name: VCA IgG ELISA
Indications For Use: The Viral Capsid Antigen (VCA) IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to VCA antigen. The Clark anti-VCA IgG assay may be used in conjunction with other Epstein-Barr serologies (EA-D IgG, VCA IgM, EBNA-1 IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis in a adult population.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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