(270 days)
For the qualitative and semi-quantitative determination of IgG antibodies to Epstein-Barr Virus (recombinant) Nuclear Antigen-1 (EBV-EBNA-1 IgG) in human serum by indirect enzyme immunoassay. The Is-EBV-EBNA-1 IgG Test Kit may be used in combination with other Epstein-Barr serologies (Viral Capsid Antigen (VCA) IgG and IgM , Epstein-Barr Nuclear Antigen-1 (EBNA-1) IgM, Early Antigen-Diffuse (EA-D) IgG and IgM and heterophile antibody as an aid in the diagnosis of infectious mononucleosis (IM). The evaluation of paired sera, to determine a significant increase in EBNA-1 IgG antibody titer, can also aid in the diagnosis of acute infection. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated Processor.
The CEBV-EBNA-1 IgG ELISA Kit is an enzyme-linked inımunosorbent assay (ELISA) for the detection of IgG to Epstein Barr Nuclear antigen-1 in human serum.
Here's a breakdown of the acceptance criteria and study information for the ZEBV EBNA-1 IgG ELISA Kit, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as a separate section with predefined targets. Instead, it presents the "Performance Characteristics" of the proposed device (Diamedix Is-EBV-EBNA IgG ELISA Kit) and compares them to a predicate device (Wampole EBNA-1 IgG ELISA). The implicit acceptance criteria are that the device performs comparably to or better than the predicate device.
Here's a table summarizing the reported performance, which serves as the fulfillment of these implicit criteria:
| Performance Characteristic | Proposed Device (Diamedix Is-EBV-EBNA IgG ELISA Kit) | Predicate Device (Wampole EBNA-1 IgG ELISA) |
|---|---|---|
| Relative Sensitivity | 98.0% | 97.8% |
| Relative Specificity (Current Infection) | 87.2% | (Not explicitly listed for current infection, but overall specificity is 100%) |
| Relative Specificity (Seronegative) | 97.1% | 100% (overall specificity) |
| Agreement | 95.4% | 98.3% |
| Intra-assay Precision (Manual) | 2.46-8.69% CV | (Not explicitly listed) |
| Intra-assay Precision (MAGO Plus) | 3.33-6.55% CV | (Not explicitly listed) |
| Interassay Precision (Manual) | 3.73-8.86% CV | 7.70-10.78% CV (Inter-Site Precision) |
| Interassay Precision (MAGO Plus) | 7.80-9.23% CV | (Not explicitly listed) |
| Cross-reactivity | No cross-reactivity with VZV, CMV, HSV | No cross-reactivity |
| Correlation (Manual vs. MAGO Plus) | Pearson Correlation Coefficient: 0.991 | Not Applicable (MAGO Plus compatibility is for the proposed device) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Sensitivity and Specificity Test Set: 175 sera
- 102 convalescent sera
- 34 seronegative sera
- 39 current (recent) infection sera
- Data Provenance: The document does not specify the country of origin. It indicates that the sera were from "one hundred and seventy-five patients" and were tested by an "independent clinical commercial laboratory." The study is retrospective, as the patient sera were "characterized using commercially available kits" prior to being tested with the proposed device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The ground truth for the test set was established by characterizing sera "using commercially available kits for VCA IgG, VCA IgM, EBNA IgG and heterophile antibodies." This implies that the ground truth was based on the results of established diagnostic assays, not direct expert interpretation of patient samples. Therefore, information about the number or qualifications of clinicians/experts interpreting these initial commercial kit results is not provided or directly relevant in the context of this study design.
4. Adjudication Method for the Test Set
There is no mention of an adjudication method in the context of establishing the ground truth or evaluating the test results. The categorization of sera (convalescent, seronegative, current infection) was based directly on the results of predicate commercial kits.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is an immunoassay kit for detecting antibodies, not an imaging or diagnostic device that involves human readers interpreting results. The comparison is between the proposed kit's performance and a predicate kit's performance, as well as the proposed kit's performance with manual vs. automated processing.
6. Standalone (Algorithm Only) Performance
Yes, the study primarily evaluates the standalone performance of the Diamedix Is-EBV-EBNA-1 IgG ELISA Kit itself. It's a laboratory diagnostic test kit, not an algorithm in the typical sense of AI. The performance characteristics (sensitivity, specificity, precision) are inherent to the kit's design and chemical reactions, whether performed manually or on an automated platform (MAGO Plus). The "algorithm" here refers to the immunoassay procedure and interpretation criteria.
7. Type of Ground Truth Used
The ground truth used was expert consensus derived from a panel of commercially available diagnostic kits. Specifically, sera were characterized using:
- VCA IgG (Viral Capsid Antigen IgG)
- VCA IgM (Viral Capsid Antigen IgM)
- EBNA IgG (Epstein-Barr Nuclear Antigen IgG)
- Heterophile antibodies
Based on results from these kits, sera were categorized into:
- Convalescent (past infection)
- Seronegative
- Current (recent) infection
8. Sample Size for the Training Set
The document describes a 510(k) submission for a diagnostic kit, not a machine learning model. Therefore, there is no explicit "training set" in the sense of data used to train an AI algorithm. The development of the kit (e.g., reagent formulation, optimization of conditions) would have involved internal R&D, but this document focuses on the validation of the finalized kit.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an AI model, this question is not applicable to this submission. The "ground truth" used in the performance validation study (clinical sensitivity and specificity) was established by characterizing patient sera with commercially available diagnostic kits, as described in point 7.
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2 | 16/99
Job 39
510k 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: K981829
Applicant Information;
| Date Prepared: | May 18, 1998 |
|---|---|
| Name: | Columbia Bioscience, Inc. |
| Address: | 8775 M Centre Park Drive, #559Columbia, MD 21045 |
| Contact Person: | Norman Jenkins |
|---|---|
| Phone Number: | 410-995-1278 |
| Fax Number: | 410-995-0508 |
Device Information:
| Trade Name: | ZEBV EBNA-1 IgG ELISA Kit |
|---|---|
| Common Name. | EBV Nuclear Antigen-1 EIA Test |
| Classification Name; | Epstein Barr Virus Serological Reagent |
Equivalent Device Description:
Wampole EBNA-1 IgG ELISA.
Wampole EBNA-1 IgG ELISA kit contains instructions and materials for the qualitative and semi-quantitative detection of IgG antibodies to EBV-EBNA-1 IgG in human serum by indirect ELISA
Device Description: The CEBV-EBNA-1 IgG ELISA Kit is an enzyme-linked inımunosorbent assay (ELISA) for the detection of IgG to Epstein Barr Nuclear antigen-1 in human serum.
Intended Use: For the qualitative and semi-quantitative determination of IgG antibodies to Epstein-Barr Virus (recombinant) Nuclear Antigen-1 (EBV-EBNA-1 IgG) in human serum by indirect enzyme immunoassay. The Is-EBV-EBNA-1 IgG Test Kit may be used in combination with other Epstein-Barr serologies (Viral Capsid Antigen (VCA) IgG and IgM , Epstein-Barr Nuclear Antigen-1 (EBNA-1) IgM, Early Anigen-Diffise (EA-D) IgG and IgM and heterophile antibody as an aid in the diagnosis of infectious mononucleosis (IM). The evaluation of paired sera, to determine a significant increase in EBNA-1 IgG antibody titer, can also and in the diagnosis of acute infection. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated Processor.
Principle of Procedure:
Recombinant EBNA-1 antigen is bound to microwells. Diluted patient sera. Cut-Off Calibrator and controls are placed inthe microwells and incubated. Anti-EBNA-1 IgG antibodes, if present, will bind to the antigen forming antigen-antibody complexes. Residual sample is eliminated by aspirating and washing. Conjugate (horseradish peroxidase-labeled anti-human IgG) is added and will bind to these complexes. Unbound conjugate is removed by aspiration and washing. Substrate is then added and incubated. In the presence of bound enzyme the substrate is converted to an end product. The absorbance of this end product can be read spectrophotometrically at 4.0
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nm (reference 600-630 nm) and is directly proportional to the concentration of lgG antibodies to EBNA-1 present in the sample.
The Is-EBV-EBNA-1 IgG ELISA kit and the Wampole EBNA-1 IgG ELISA are substantially equivalent in that.
- Both are in vitro immunologic methods. ﻟﺴﻨﺔ
- Both are intended for use in the detection of IgG antibody to EBV-EBNA-1 in human serum 2.
- Both are based on the formation of a complex between EBNA-1 antigens and antibody నా
-
- Both use antigen coated microtiter plates.
- Both are qualitative/semi-quantitative assays. ળ
- Both use goat anti-human IgG conjugated to horseradish peroxidase. 6.
-
- Both use TMB as the enzyme substrate
A detailed comparison between the proposed devise and the predicate device is shown in Table 1
Conclusions: The Diamedix Is-EBV-EBNA-1 IgG is substantially equivalent to the Wampole EBNA-1 ELISA for the detection of IgG antibodies to EBV-EBNA-1 in human serum to aid in the diagnosis of infectious mononucleosis. The device is as safe, as effective, and performs as well as the legally marketed device described.
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| Table 1 | ||
|---|---|---|
| PROPOSED DEVICEDiamedix Is-EBV-EBNA IgG ELISA Kit | PREDICATE DEVICEWampole EBNA-1 IgG ELISA | |
| Intended Use | For the qualitative and semi-quantitative determination ofIgG antibodies to Epstein-Barr Virus (recombinant)Nuclear Antigen-1 (EBV-EBNA-1 IgG) in human serumby indirect enzyme immunoassay. The Is-EBV-EBNA-1IgG Test Kit may be used in combination with otherEpstein-Barr serologies (Viral Capsid Antigen (VCA)IgG and IgM, Epstein-Barr Nuclear Antigen-1 (EBNA-1)IgM, Early Antigen-Difluse (EA-D) IgG and IgM andheterophile antibody as an aid in the diagnosis ofinfectious mononucleosis (IM). The evaluation of pairedsera, to determine a significant increase in EBNA-1 IgGantibody titer, can also aid in the diagnosis of acuteinfection. These reagents can be used either manually orin conjunction with the MAGO® Plus AutomatedProcessor. | The Wampole Laboratories (Wampole) Epstein-BarrVirus Nuclear Antigen-1 (EBNA-1) IgG Enzyme-LinkedImmunosorbent Assay (ELISA) is intended for thequalitative and semi-quantitative determination of IgGantibody in human serum to EBNA-1 recombinantantigen. The Wampole EBNA-1 IgG assay may be usedin conjunction with other Epstein-Barr serologies (VCAIgG, VCA IgM, EA (R&D), and heterophile) as an aid inthe diagnosis of infectious mononucleosis. |
| Methodology | Enzyme immunoassay (EIA) | Enzyme Linked Immunosorbent Assay (ELISA) |
| Specifications | For in vitro diagnostic use.For use with fresh or frozen human serum.Avoid lipemic, hemolyzed, contaminated, or icteric sera.Assay performed on 1:21 dilution of serum at 18-30°C.Store at 2-8°C. | For in vitro diagnostic use. For use with fresh or frozenhuman serum. Assay performed on 1:21 dilution ofserum at 21-25°C. Store at 2-8°C. |
| Design | Is-EBV-EBNA IgG Test Kit. 96 determinations. Un-diluted Calibrator, Positive, and Negative controls. | EBNA-1 IgG ELISA. 96 determinations. UndilutedCalibrator, High positive, Low positive, and Negativecontrols. |
| Principles ofOperation | Purified, recombinant EBNA-1 antigen is bound tomicrowells (solid phase). Diluted human serum is assesto the microwell which binds human anti-EBNA IgG, ifpresent. Solid phase is washed and exposed to anti-human IgG conjugate. Solid phase is washed andexposed to enzyme substrate to develop color. Strongacid is added to stop reaction. The color is read at450/600 nm on an EIA reader. | Diluted patient serum is incubated with purified,recombinant EBNA-1 antigen bound to the solid surfaceof a microtiter well. If IgG antibodies against EBV-EBNA-1 are present in the serum, antigen-antibodycomplexes are formed. These complexes bind with HRPlabeled anti-human IgG which react with the addition ofchromogen, resulting in a color development. Theabsorbance is measured at 450/630 nm. |
| PerformanceCharacteristics | Relative Sensitivity: 98.0%Relative Specificity (Current Infection): 87.2% RelativeSpecificity (Seronegative): 97.1Agreement: 95.4%Intra-assay Precision (Positive samples, all sites)Overall Manual- 2.46-8.69 MAGO Plus- 3.33-6.55Interassay Precision (Positive samples, all sites)Overall Manual- 3.73-8.86 MAGO Plus- 7.80-9.23No Cross-reactivity | Relative Sensitivity: 97.8%Relative Specificity: 100%Agreement: 98.3%Inter-Site Precision (Positive samples, all sites)Overall: 7.70-10.78%No Cross-reactivity |
| Enzyme Used | Horesradish Peroxidase | Horesradish Peroxidase |
| Substrate | TMB | TMB |
| Specimen | SerumSample Absorbance/Cut-off Absorbance = Index Value | SerumSample Absorbance/Cut-off Absorbance = ISR |
| Calculation of Results | ||
| Interpretation | <0.90 Negative for EBNA IgG0.90-1.09 Equivocal for EBNA IgG> 1.10 Positive for EBNA IgG | ≤0.90 Negative for EBNA-1 IgG0.91-1.09 Equivocal for EBNA-1 IgG> 1.10 Positive for EBNA-1 IgG |
| Materials | 96 microwells in 12x8 strips, Wash concentrate, SampleDiluent, Conjugate, Calibrator, Controls, Substrate, StopSolution | 96 microwells in 12x8 strips, Wash Buffer, SerumDiluent, HRP Conjugate, Calibrator, Controls,Chromogen, Stop Solution |
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Performance Characteristics
A. Clinical Sensitivity and Specificity Using Characterized Sera
Scra from one hundred and seventy-five patients were characterized using commercially available kits for VCA IgG, VCA IgM, EBNA IgG and heterophile antibodies. Based on the results of this testing, the patient sera were characterized as follows :
- · 102 sera were characterized as convalescent (past infection). These were positive for VCA IgG and/or EBNA IgG antibodies and negative for VCA IgM and heterophile antibody.
- · 34 sera were characterized as seronegative. These were negative for VCA IgG, VCA IgM, EBNA IgG and heterophile antibody.
- · 39 sers were characterized as having a current (recent) infection. These were positive for VCA IgM and/or heterophile antibody and were negative for EBNA IgG.
All 175 sera were then tested by an independent clinical commercial laboratory in the 18-15BNA-1 IgG Test Kit. The results obtained are shown in Table 2:
| TABLE 2 | Convaloscont | Current Infection | Seronegative | |
|---|---|---|---|---|
| 1 IgG | POSITIVE | 100 | 5 | 1 |
| NEGATIVE | 2 | 34 | 33 | |
| *EQUIVOCAL | 0 | 0 | 0 |
EBV Serological Status
15-1:BNA-1
- · Of the 102 convalescent sera tested, 100 were positive for anti-EBNA IgG and two were negative.
- · Of the thirty-mine current (recent) infection samples tested, thirty-four were negative for anti-EBNA IgG and five were positive.
- · Of the thirty-four seronegative sera tested, thirty-three were negative for anti-EBNA IgG and one serum icsted positive.
- · The overall agreement of the Is-EBNA IgG test kit compared to EBV serological status was 161/175 = 95.4%.
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B. Precision
To decemine the precision of the Is-EBNA-1 IgG Test Kit, four positive shares and site is site its is site it in site it it site it it site it it sit site it it sit site it i To deternine the precision of the IS-EBNA-T ISO Text Kits in 1981 your read interassay precision obtained at each site is shown in Tables 3, 4 and 5.
TABLE 3 : Site #1 - Intra-Assay and Interassay Precision
| SERUM | INTRA-ASSAY RUN 1 | INTRA-ASSAY RUN 2 | INTRA-ASSAY RUN 3 | INTERASSAY | ||||
|---|---|---|---|---|---|---|---|---|
| MEANINDEX | CV% | MEANINDEX | CV% | MEANINDEX | CV% | MEANINDEX | CV% | |
| A (POS) | 1.61 | 4.44 | 1.62 | 6.57 | 1.58 | 8.23 | 1.60 | 6.47 |
| B (POS) | 2.28 | 4.27 | 2.30 | 5.84 | 2.19 | 7.04 | 2.26 | 5.98 |
| C (POS) | 1.54 | 6.26 | 1.43 | 7.15 | 1.48 | 8.69 | 1.49 | 7.82 |
| D (POS) | 1.91 | 4.43 | 1.82 | 4.74 | 1.82 | 4.18 | 1.85 | 4.92 |
| E (NEG) | 0.08 | 20.41 | 0.07 | 62.39 | 0.04 | 42.61 | 0.06 | 53.16 |
| F (NEG) | 0.49 | 12.12 | 0.39 | 12.06 | 0.36 | 10.72 | 0.42 | 17.68 |
| CAL | 1.00 | 9.56 | ||||||
| PC | 1.44 | 6.84 | ||||||
| NC | 0.04 | 110.2 |
| TABLE 4 : Site #2- Intra-Assay and Interassay Precision |
|---|
| --------------------------------------------------------- |
| SERUM | INTRA-ASSAY RUN 1MEANINDEX | CV% | INTRA-ASSAY RUN 2MEANINDEX | CV% | INTRA-ASSAY RUN 3MEANINDEX | CV% | INTERASSAYMEANINDEX | CV% | |
|---|---|---|---|---|---|---|---|---|---|
| A (POS) | 1.54 | 2.97 | 1.52 | 4.47 | 1.50 | 4.41 | 1.55 | 4.19 | |
| B (POS) | 2.30 | 2.96 | 2.25 | 3.13 | 2.35 | 3.80 | 2.30 | 3.73 | |
| C (POS) | 1.42 | 5.56 | 1.40 | 3.10 | 1.51 | 4.60 | 1.44 | 5.45 | |
| D (POS) | 1.77 | 2.46 | 1.73 | 2.82 | 1.88 | 2.88 | 1.79 | 4.49 | |
| E (NEG) | 0.08 | 43.69 | 0.08 | 8.34 | 0.10 | 12.57 | 0.08 | 27.49 | |
| F (NEG) | 0.42 | 39.98 | 0.34 | 5.60 | 0.53 | 7.67 | 0.43 | 28.98 | |
| CAL | 1.00 | 1.74 | n = 18 | ||||||
| PC | 1.54 | 3.48 | n = 12 | ||||||
| NC | 0.05 | 28.39 | n = 12 |
| TABLE 5 : Site #3 - Intra-assay and Interassay Precision | ||
|---|---|---|
| -- | ---------------------------------------------------------- | -- |
| SERUM | INTRA-ASSAY RUN 1MEANINDEX | INTRA-ASSAY RUN 1CV% | INTRA-ASSAY RUN 2MEANINDEX | INTRA-ASSAY RUN 2CV% | INTRA-ASSAY RUN 3MEANINDEX | INTRA-ASSAY RUN 3CV% | INTERASSAYMEANINDEX | INTERASSAYCV% |
|---|---|---|---|---|---|---|---|---|
| A (POS) | 1.72 | 6.19 | 1.51 | 4.50 | 1.63 | 7.41 | 1.62 | 8.20 |
| B (POS) | 2.53 | 5.89 | 2.33 | 4.95 | 2.42 | 6.25 | 2.43 | 6.51 |
| C (POS) | 1.57 | 4.41 | 1.39 | 5.22 | 1.51 | 7.10 | 1.49 | 7.45 |
| D (POS) | 2.04 | 5.41 | 1.78 | 6.14 | 2.00 | 8.52 | 1.94 | 8.86 |
| E (NEG) | 0.06 | 26.22 | 0.06 | 23.80 | 0.04 | 38.91 | 0.05 | 32.41 |
| F (NEG) | 0.45 | 10.04 | 0.31 | 6.19 | 0.49 | 7.99 | 0.42 | 20.80 |
| CAL | 1.00 | 5.38 | ||||||
| PC | 1.63 | 5.21 | ||||||
| NC | 0.05 | 10.83 |
C. Specificity with Potentially Cross-Reactive Sera
Sixteen sera, non-reactive) for IgG antibudies to EBNA-1 in the Is-EBNA-1 IgG Test Kit, were tested by IIIA for IgG antibody to varietla zoster, cytomegalovirus and herpes simplex virus. 15/15 anti-VZV IgC passive sers were non-reactive for anti-EBNA-1 IgG; 3/3 anti-CMV IgG positive sera were non-reactive for anti-EBNA-1 IgG and 3/3 and-HSV positive sera were non-reactive for anti-EDNA-1 IgG. "This suggests that no specific crass-tenchyly should be expected with the Is-EBNA-1 IgG Test Kit from these analytes.
D. Correlation of Manual and MAGO Plus Results
The Is-EBNA-1 IgG Test Kit has been developed for automated as well as manual use. To demonstrate the equivalence of the manual and MAGO Plus procedures, the results of 197 serum samples tested by hoth methods were plotted. A seattergram and regression line of the results obtained with 95% confidence interests in shown in Figure 3. The data indicate good correlation with a Pearson Correlation Coefficient of 0.991.
.
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Image /page/5/Figure/3 description: The image is a scatter plot that shows the relationship between MAGO PLUS INDEX VALUES and MANUAL INDEX VALUES. The x-axis represents MANUAL INDEX VALUES, ranging from 0 to 6, while the y-axis represents MAGO PLUS INDEX VALUES, ranging from -1 to 7. A regression line is plotted on the scatter plot, with the equation Y = -0.00022 + 1.1060 X, and the correlation coefficient (r) is 0.991.
FIGURE 3 : Manual and MAGO Plus Result Correlation
D. MAGO Plus Precision
The precision of the assay when performed on the MAGO Plus Autonated EIA Processor was determined by assaying six sera ten times each in three different runs. Table 6 shows the intra-and interassay precision obtained using the MAGO Plus.
| SERUM | INTRA-ASSAY RUN 1 | INTRA-ASSAY RUN 2 | INTRA-ASSAY RUN 3 | INTERASSAY | |||||
|---|---|---|---|---|---|---|---|---|---|
| MEAN INDEX | CV% | MEAN INDEX | CV% | MEAN INDEX | CV% | MEAN INDEX | CV% | ||
| A (POS) | 1.49 | 3.81 | 1.65 | 6.55 | 1.38 | 4.58 | 1.51 | 9.05 | |
| B (POS) | 2.26 | 5.60 | 2.55 | 3.33 | 2.15 | 5.02 | 2.32 | 8.65 | |
| C (POS) | 1.52 | 5.19 | 1.66 | 5.82 | 1.39 | 6.30 | 1.52 | 9.23 | |
| D (POS) | 1.76 | 6.11 | 1.94 | 4.35 | 1.69 | 5.18 | 1.80 | 7.00 | |
| E (NEG) | 0.09 | 35.14 | 0.10 | 0.00 | 0.04 | 129.10 | 0.08 | 56.11 | |
| F (NEG) | 0.37 | 42.35 | 0.38 | 11.10 | 0.34 | 15.19 | 0.36 | 26.54 | |
| CAL | 1.00 | 4.95 | |||||||
| PC | 1.40 | 14.29 | |||||||
| NC | 0.07 | 86.60 |
TABLE 6 : Sile #2- InIra-Assay and Interassay Precision - MAGO Plus
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Image /page/6/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 16 1999
Diamedix Corporation c/o Norman Jenkins Columbia Bioscience, Inc. 8775 M Centre Park Drive, #559 Columbia, MD 21045
K981829 Re: Trade Name: Is EBV-EBNA-1 IgG ELISA Test System Regulatory Class: I Product Code: GNP Dated: December 14, 1998 Received: December 14, 1998
Dear Mr. Jenkins:
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 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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510(k) Number: K981829
Device Name: EBV- EBNA-1 IgG ELISA
Indications For Use: The The EBNA-1 IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) For the qualitative and semi-quantitative determination of IgG antibodies to Epstein-Barr Virus (recombinant) Nuclear Antigen-1 (EBV-EBNA-1 IgG) in human serum by indirect enzyme immunoassay. The Is-EBV-EBNA-1 IgG Test Kit may be used in combination with other Epstein-Barr serologies (Viral Capsid Antigen (VCA) IgG and IgM , Epstein-Barr Nuclear Antigen-1 (EBNA-1) IgM, Early Antigen-Diffuse (EA-D) IgG and IgM and heterophile antibody as an aid in the diagnosis of infectious mononucleosis The evaluation of paired sera, to determine a significant increase in EBNA-(IM). 1 IgG antibody titer, can also aid in the diagnosis of acute infection. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated Processor.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Y (Per 21 CFR 801.109)
OR
Over-The Counter Use (Optional Format 1-2-96)
Division of Clinical Laboratory Devices K981829 510(k) Number_
(
§ 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).