(222 days)
The Biotest EA IgG ELISA is an enzyme immunoassay using recombinant antigens for the qualitative detection of IgG antibodies to the Epstein-Barr Virus Early Antigens (EA) p54 and p138 in human serum or plasma. Results obtained with this test, in conjunction with other clinical and patient data obtained in assays for other Epstein-Barr virus-specific antibodies such as anti-Early Antigen IgM and anti-EBNA-1 IgG, assist in serological diagnosis of EBV infection in pediatric and adult populations.
Using recombinant DNA technology, Biotest has developed three highly purified EBV antigens for use in their ELISA test system.
- EBNA-1 p72: Major antigen of the EBNA complex. The recombinant protein does not contain the glycine-alanine copolymer, a structural feature of EBNA-1, which shows cross-reactivities with certain autoantibodies and CMV (IgM response).
- EA-D p64: Early antigen. Dominant immunogen of the EA-D complex.
- EA p138: Early antigen and major DNA binding protein. This highly reactive antigen is not detectable in EA immunofluorescence assays based on chemically induced Raji cells (deletion within the Raji genome).
The EBV immune status will be determined by the detection of specific antibodies directed against EBV proteins according to the principle of the indirect ELISA. The antigens are purified to apparent homogeneity and immobilized on the solid phase (microtest plate, 96 wells). If the patient's serum contains specific antibodies they will bind during the first incubation. Non-specific antibodies are removed by washing steps. During a second incubation the captured IgG or IgM antibodies are labeled. This is performed by addition of murine monoclonal anti-human IgG or IgM antibody-enzyme-conjugates. The final reaction converts a colorless substrate to a colored product. The concentration of color after a definite time is related to the concentration of antibody in the serum sample.
The Biotest EA IgG ELISA is an enzyme immunoassay designed for the qualitative detection of IgG antibodies to Epstein-Barr Virus Early Antigens (EA) p54 and p138 in human serum or plasma. It is intended for use in conjunction with other clinical and patient data from assays for other EBV-specific antibodies (e.g., anti-Early Antigen IgM and anti-EBNA-1 IgG) to aid in the serological diagnosis of EBV infection.
Here's an analysis of the acceptance criteria and the study that proves the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria in terms of specific numeric thresholds for sensitivity, specificity, or agreement. Instead, it presents the results of comparative studies and implicitly uses the performance of existing methods as a benchmark for substantial equivalence. For the purpose of this analysis, we will infer the "acceptance criteria" as the performance demonstrated to achieve substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance (Biotest EA IgG) |
|---|---|
| Relative Sensitivity (vs. IFA) | ≥ 78.4% (Combined Sites) |
| Relative Specificity (vs. IFA) | ≥ 97.3% (Combined Sites) |
| Relative Agreement (vs. IFA) | ≥ 83.6% (Combined Sites) |
| Clinical Sensitivity (vs. Int.) | 98.5% |
| Clinical Specificity (vs. Int.) | 100% |
| Clinical Agreement (vs. Int.) | 98.7% |
| No cross-reactivity with other viruses | Observed |
| No cross-reactivity with autoantibodies | Observed |
| Inter-run %CV (Reproducibility) | Max of 16.6% (Site 1), 17.4% (Site 2) |
| Intra-run %CV (Reproducibility) | Max of 13.2% (Site 1), 19.2% (Site 2) |
| Inter-lab %CV (Reproducibility) | Max of 19.8% |
Note: "vs. IFA" refers to direct comparison with commercially available or published EA IgG IFA tests. "vs. Int." refers to comparison with clinical interpretation based on antibody patterns and clinical diagnosis.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 408 patient samples.
- Data Provenance: The samples were obtained from both pediatric and adult patients (ages 1 to 74) at two geographically distinct locations. The samples represented various stages of EBV infection: acute (139), late acute (34), recent past (12), past (120), reactivation (22), past/probable reactivation (11), and negative (70). The study was a clinical study, suggesting it was prospective in nature, collecting and testing samples for a specific evaluation. The country of origin is not explicitly stated, but the submission is to the US FDA, implying that the study was likely conducted in the US or under US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts used or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, it mentions two methods for evaluating performance:
- Direct comparison with IFA: This implies the "ground truth" for this comparison was the results from commercially available or published EA IgG IFA tests. The expertise would lie within the validated methodology and interpretation of those IFA tests.
- Comparison with clinical interpretation: This "ground truth" was based on "serological pattern analysis for each state of infection, including acute, convalescent, Past, Reactivation and Probable Reactivation/past, and Negative." This process would inherently involve expert medical knowledge and clinical judgment (likely from infectious disease specialists or clinical microbiologists) to establish the "stage of infection based on antibody patterns and clinical diagnosis at the time the specimen was drawn."
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). For the direct comparison with IFA, it's a direct comparison of results. For the comparison with clinical interpretation, the ground truth was derived from "expected serological pattern analysis" and "clinical diagnosis," which implies a consensus or established criteria for determining the infection stage, rather than individual expert adjudication of each case.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This section is not applicable to the provided document. The Biotest EA IgG ELISA is an in vitro diagnostic (IVD) device, specifically an immunoassay for detecting antibodies, not an AI-powered diagnostic imaging or decision support tool that assists human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers was not performed or described.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
This section is not applicable in the context of an immunoassay. The Biotest EA IgG ELISA is itself a standalone diagnostic test. Its performance is evaluated intrinsically through its ability to detect antibodies in patient samples, not as an algorithm separate from human intervention for interpretation in the same way "standalone algorithm performance" is typically discussed for imaging AI. The "algorithm" here is the chemical and enzymatic reaction within the ELISA, and its output (spectrophotometer reading) is directly interpreted.
7. The Type of Ground Truth Used
Two types of ground truth were used for different aspects of performance evaluation:
- Established Diagnostic Tests (IFA): For the relative sensitivity and specificity, the ground truth was derived from the results of commercially available or published EA IgG Immunofluorescence Assay (IFA) tests.
- Expert Clinical Interpretation/Serological Pattern Analysis: For clinical sensitivity and specificity, the ground truth was established by "clinical interpretation (stage of infection based on antibody patterns and clinical diagnosis at the time the specimen was drawn)." This is a form of expert consensus or established diagnostic criteria based on known serological markers and patient presentation.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning. The device is an ELISA kit, which is a biochemical assay, not an algorithm that requires a separate training phase with a distinct dataset. The "development" of the highly purified EBV antigens (EBNA-1 p72, EA-D p64, EA p138) and the optimization of the ELISA system would have involved internal validation and optimization studies by Biotest, but these are not referred to as a "training set" in the sense of AI model development.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, there is no explicit mention of a "training set" as it would be understood in machine learning. The "ground truth" in the development of an immunoassay would be established through:
- Antigen purity and specificity: Ensuring the recombinant antigens (p72, p54, p138) correctly represent the target EBV EA epitopes without undesirable cross-reactivity. This would involve molecular biology techniques, protein characterization, and immunochemical assays.
- Assay optimization: Fine-tuning reagent concentrations, incubation times, and washing steps to achieve optimal signal-to-noise ratio, linearity, and precision using well-characterized positive and negative control samples. These controls would be independently verified (e.g., by reference methods or clinical status).
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JUN 1999 1999
ATTACHMENT I
REVISED 510(k) SUMMARY
{1}------------------------------------------------
510(k) Summary of Information Respecting Safety and Effectiveness
- A. Name and Address of Submitter
| Company Name and Address: | Biotest Diagnostics Corporation66 Ford Road, Suite 131Denville, NJ 07834 |
|---|---|
| Telephone: | (609) 397-8511 |
| FAX: | (609) 397-8224 |
| Contact Person: | Patricia E. Bonness, Official Correspondent |
| Date 510(k) Summary was Prepared: October 26, 1998 | |
| Device Names | |
| Proprietary Name: | Biotest Anti-EBV RecombinantEA IgG |
| Common Name: | EBV EA IgG |
| Classification Name: | Epstein-Barr virus serological reagents |
- C. Legally Marketed Device
B.
Biotest Diagnostics claims substantial equivalence to the EBV-EA Test (K872617) currently in commercial distribution by Gull Laboratories, Inc., Salt Lake City, UT.
D. Device Description
Using recombinant DNA technology, Biotest has developed three highly purified EBV antigens for use in their ELISA test system.
- EBNA-1 p72: Major antigen of the EBNA complex. The recombinant protein does not contain the glycine-alanine copolymer, a structural feature of EBNA-1, which shows cross-reactivities with certain autoantibodies and CMV (IgM response).
- EA-D p64: Early antigen. Dominant immunogen of the EA-D complex.
- EA p138: Early antigen and major DNA binding protein. This highly reactive antigen is not detectable in EA immunofluorescence assays based on chemically induced Raji cells (deletion within the Raji genome).
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| BiotestAnti-EBVrecombinant | p72 | p54 | p134 | anti-human IgG | anti-human IgM |
|---|---|---|---|---|---|
| EA IgM | X | X | X | ||
| EA IgG | X | X | X | ||
| EBNA IgG | X | X |
Biotest Anti-EBV ELISA TESTS
The EBV immune status will be determined by the detection of specific antibodies directed against EBV proteins according to the principle of the indirect ELISA. The antigens are purified to apparent homogeneity and immobilized on the solid phase (microtest plate, 96 wells). If the patient's serum contains specific antibodies they will bind during the first incubation. Non-specific antibodies are removed by washing steps. During a second incubation the captured IgG or IgM antibodies are labeled. This is performed by addition of murine monoclonal anti-human IgG or IgM antibody-enzyme-conjugates. The final reaction converts a colorless substrate to a colored product. The concentration of color after a definite time is related to the concentration of antibody in the serum sample.
E. Intended Use
The Biotest EA IgG ELISA is an enzyme immunoassay using recombinant antigens for the qualitative detection of IgG antibodies to the Epstein-Barr Virus Early Antigens (EA) p54 and p138 in human serum or plasma. Results obtained with this test, in conjunction with other clinical and patient data obtained in assays for other Epstein-Barr virus-specific antibodies such as anti-Early Antigen IgM and anti-EBNA-1 IgG, assist in serological diagnosis of EBV infection in pediatric and adult populations.
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- F. Comparison with Predicate Device
A summary comparison of the features of the Biotest EA IgG and the Gull EA IgG test kits is provided in Table 1 below:
Table 1
Feature Comparison of Biotest and Gull EBV-EA Test Kits
| Biotest | Gull | |
|---|---|---|
| Intended Use | Detection of IgG antibodiesto EBV EAQualitative only | Detection of IgG antibodiesto EBV EAQualitative and quantitative |
| Assay Method | ELISA | Indirect fluorescent antibody (IFA) |
| Reactive Ingredients | Recombinant EBV (EA p54/p138)Peroxidase-conjugated monoclonalanti-human IgG (mouse) | EBV infected Raji cellsFluorescein-labeledanti-human IgG (caprine) |
| Specimen: TypeMin. VolumeStorage | Serum or plasma25 µl2 - 8°C or -20°C | Serum15 µl of 1:10 dilution2 - 8°C/7 days or -20°C |
| Controls | NegativePositive | NegativePositive |
| Chromogen | TMB | Fluorescein; Evans blue |
| Results:Evaluation | spectrophotometer @ 450 nm | Fluorescent microscope |
| Kit Size | 96 tests | 100 tests |
୧ ୦
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G. Performance Data
Sensitivity/Specificity
The performance of the Biotest EA IgG ELISA was evaluated in a clinical study of 408 patient samples conducted at two geographically distinct locations. Samples were obtained from both pediatric and adult patients (ages 1 to 74) representing acute (139), late acute (34), recent past (12), past (120), reactivation (22), past/probable reactivation (11), and negative (70) disease stages of EBV infection.
Two methods were used to evaluate the performance of the Biotest EA IgG ELISA: direct comparison with commercially available or published EA IgG IFA tests, and comparison with clinical interpretation (stage of infection based on antibody patterns and clinical diagnosis at the time the specimen was drawn).
Results of the direct comparison with IFA for both sites combined demonstrated a relative sensitivity of 78.4% and a relative specificity of 97.3%.
Table 1
Clinical Site 1 Direct Comparison to EA IgG IFA
| EA IgG IFA | |||
|---|---|---|---|
| + | - | Total | |
| Biotest + | 125 | 0 | 125 |
| Biotest - | 32 | 51 | 83 |
| Total | 157 | 51 | 208 |
Relative Sensitivity = 79.6% Relative Specificity = 100% Relative Agreement = 84.6% (C.I. = 73.3 to 85.9%) (C.I. = 93.0 to 100%)
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Table 2
| EA IgG IFA | |||
|---|---|---|---|
| + | - | Total | |
| Biotest + | 107 | 3 | 110 |
| Biotest - | 32 | 58 | 90 |
| Total | 139 | 61 | 200 |
Clinical Site 2 Direct Comparison to EA IgG IFA
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ Relative Sensitivity = 77.0% Relative Specificity = 95.1% Relative Agreement = 82.5%
(C.I. = 70 to 84%) (C.I. = 86.3 to 99%)
Table 3
Combined Site Results Direct Comparison to EA IgG
| EA IgG IFA | |||
|---|---|---|---|
| + | - | Total | |
| Biotest + | 232 | 3 | 235 |
| Biotest - | 64 | 109 | 173 |
| Total | 296 | 112 | 408 |
Relative Sensitivity = 78.4% Relative Specificity = 97.3% Relative Agreement = 83.6%
(C.I. = 73.7 to 83.1%) (C.I. = 92.4 to 99.4%)
{6}------------------------------------------------
Results based on Clinical Interpretation of all patient samples where Biotest ELISA EA IgG antibody responses matched expected serological pattern analysis for each state of infection, including - Acute, Convalescent (Late Acute or Recent Past), Past, Reactivation and Probable Reactivation/past, and Negative.
| Clinical Interpretation | |||||
|---|---|---|---|---|---|
| Acute | Convalescent | Past | Reactivation | Negative | |
| Result matchesBiotest | 138 | 44 | 119 | 32 | 0 |
| Result does notmatch Biotest | 1 | 2 | 1 | 1 | 70 |
| SensitivitySpecificity95% to C.I.% | 99.2%N/A96.1 - 100 | 95.6%N/A85.2 - 99.5 | 99.2%N/A95.4 - 100 | 97.0%N/A84.2 - 99.9 | N/A100%94.9 - 100 |
Total Clinical Sensitivity = 98.5% Total Clinical Specificity = 100% Total Clinical Agreement = 98.7% (C.I. = 96.6 to 99.5%) (C.I. = 94.9 to 100%)
Note: C.I. = 95% confidence intervals calculated by the exact method.
Cross Reactivity
ﻟﺴﻴﻨﺎ
No cross reactivity was observed when the Biotest EA IgG ELISA was used to test samples from patients acutely infected with:
| Herpes Simplex Virus I/II | n = 33 |
|---|---|
| Varicella Zoster Virus | n = 42 |
| Cytomegalovirus | n = 12 |
Further, no cross reactivity was observed in tests of rheumatoid factor positive (n = 10), antinuclear antibody positive (n = 5), and ASL positive (n = 15) samples
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Reproducibility
ﻟ
To evaluate the reproducibility of the Biotest EA IgG ELISA, a panel of 10 patient serum specimens (low to high positive) was tested at the clinical sites. The mean, standard deviation (S.D.) and coefficient of variation (C.V.) for inter-run, intra-run and inter-lab reproducibility are presented below.
| Inter-Run (n = 10) | Intra-Run (n = 8) | |||||
|---|---|---|---|---|---|---|
| Panel # | Mean | S.D. | % C.V. | Mean | S.D. | % C.V. |
| 1 | 2.186 | 0.167 | 7.6 | 2.209 | 0.123 | 5.6 |
| 2 | 1.871 | 0.143 | 7.6 | 2.083 | 0.108 | 5.2 |
| 3 - | 2.169 | 0.311 | 14.3 | 2.332 | 0.157 | 6.7 |
| 4 | 0.744 | 0.077 | 10.3 | 0.600 | 0.057 | 9.5 |
| 5 | 2.208 | 0.366 | 16.6 | 2.317 | 0.306 | 13.2 |
| 6 | 1.503 | 0.193 | 12.9 | 1.343 | 0.057 | 4.3 |
| 7 | 2.488 | 0.308 | 12.4 | 2.185 | 0.116 | 5.3 |
| 8 | 2.288 | 0.218 | 9.5 | 2.685 | 0.272 | 10.1 |
| 9 | 2.386 | 0.341 | 14.3 | 2.712 | 0.192 | 7.1 |
| 10 | 2.201 | 0.269 | 12.2 | 2.299 | 0.090 | 3.9 |
Site #1
Site #2
| Inter-Run (n = 4) | Intra-Run (n = 24) | |||||
|---|---|---|---|---|---|---|
| Panel # | Mean | S.D. | % C.V. | Mean | S.D. | % C.V. |
| 1 | 1.783 | 0.311 | 17.4 | 2.134 | 0.409 | 19.2 |
| 2 | 1.235 | 0.177 | 14.3 | 1.413 | 0.269 | 19.0 |
| 3 | 2.168 | 0.265 | 12.2 | 2.504 | 0.381 | 15.2 |
| 4 | 0.619 | 0.060 | 9.8 | 0.832 | 0.130 | 15.7 |
| 5 | 2.003 | 0.183 | 9.1 | 2.530 | 0.408 | 16.1 |
| 6 | 1.215 | 0.121 | 10.0 | 1.733 | 0.244 | 14.1 |
| 7 | 1.929 | 0.163 | 8.4 | 2.580 | 0.425 | 16.5 |
| 8 | 1.742 | 0.167 | 9.6 | 2.412 | 0.408 | 16.9 |
| 9 | 2.604 | 0.209 | 8.0 | 2.285 | 0.379 | 16.6 |
| 10 | 1.503 | 0.152 | 10.1 | 2.066 | 0.247 | 12.0 |
Image /page/7/Picture/6 description: The image shows the numbers 6 and 4. The number 6 is larger and to the left of the number 4. The number 4 has a superscript, which is a smaller number above and to the right of it.
{8}------------------------------------------------
Inter-Lab (n = 14)
ﻓﻲ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ
| Panel # | Mean | S.D. | % C.V. |
|---|---|---|---|
| 1 | 2.076 | 0.277 | 13.3 |
| 2 | 1.696 | 0.335 | 19.7 |
| 3 | 2.176 | 0.276 | 12.7 |
| 4 | 0.719 | 0.101 | 14.1 |
| 5 | 2.136 | 0.316 | 14.8 |
| 6 | 1.395 | 0.221 | 15.9 |
| 7 | 2.302 | 0.366 | 15.9 |
| 8 | 2.125 | 0.315 | 14.8 |
| 9 | 2.444 | 0.305 | 12.5 |
| 10 | 2.003 | 0.397 | 19.8 |
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Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract image of an eagle.
Public Health Service
JUN 9 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia E. Bonness Official Correspondent Biotest Diagnostics Corporation 66 Ford Road Suite 131 Denville. New Jersey 07834
Re: K983839
Trade Name: Biotest Anti-EBV Recombinant EA IgG Regulatory Class: I Product Code: LSE Dated: March 15, 1999 Received: March 31, 1999
Dear Ms. Bonness:
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 (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 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 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
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Page _ of _
510(k) Number (if known):
Device Name:__________________________________________________________________________________________________________________________________________________________________ Biotest Anti-EBV Recombinant EA IgG
Indications For Use:
The Biotest EA IgG is an enzyme immunoassay for the detection of IgG antibodies to the Epstein-Barr Virus (EBV-EA (Early Antigens) p54/p138) in human serum or plasma.
It is indicated for use, in conjunction with other clinical and patient data obtained in assays for other Epstein-Barr antigens such as EBNA IgG and Early Antigen IgM, in the serological diagnosis of EBV infection.
(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)
§ 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).