(270 days)
For the qualitative and semi-quantitative determination of IgG antibodies to Epstein-Barr Virus (recombinant) Early Antigen Diffuse (EBV-EA-D IgG) in human serum by indirect enzyme immunoassay. The Is-EBV-EA-D 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) IgG and IgM, Early Antigen-Diffuse (EA-D) 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 EA-D 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 Is-EBV-EA-D IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to Epstein Barr Early Antigen diffuse in human serum. Recombinant EA-D antigen is bound to microwells. Diluted patient sera, Cut-Off Calibrator and controls are placed in the microwells and incubated. Anti-EA-D IgG antibodies, if present, will bind to the antigen forming antigen-antibody complexes. Residual sample is eliminated by aspirating, 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 450 nm (reference 600-630 nm) and is directly proportional to the concentration of IgG antibodies to EA-D present in the sample.
The provided document describes the "Is-EBV-EA-D IgG ELISA Kit" and its performance characteristics, primarily for establishing substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study findings based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the "Is-EBV-EA-D IgG ELISA Kit" to meet. Instead, it presents performance characteristics and concludes substantial equivalence based on a comparison with a predicate device. The values reported for the proposed device are presented as its performance, without explicit thresholds set beforehand as "acceptance criteria."
However, we can infer performance metrics that were evaluated:
| Performance Characteristic | Reported Device Performance (Is-EBV-EA-D IgG ELISA Kit) |
|---|---|
| Relative Sensitivity (Late Infection) | 81.8% |
| Relative Sensitivity (Current Infection) | 28.1% |
| Relative Specificity (Convalescent) | 89.7% |
| Relative Specificity (Seronegative) | 100.0% |
| Overall Agreement | 79.9% |
| Intra-assay Precision (Manual) | 2.07-13.88% CV (Positive samples, all sites collectively, range across samples) |
| Intra-assay Precision (MAGO Plus) | 1.77-18.00% CV (Positive samples, all sites collectively, range across samples) |
| Inter-assay Precision (Manual) | 5.12-9.08% CV (Positive samples, all sites collectively, range across samples) |
| Inter-assay Precision (MAGO Plus) | 5.09-11.61% CV (Positive samples, all sites collectively, range across samples) |
| Cross-reactivity | No cross-reactivity expected with Varicella Zoster, Cytomegalovirus, and Herpes Simplex Virus. (Tested with 16 sera, 15 anti-VZV IgG positive, 3 anti-CMV IgG positive, 3 anti-HSV positive, all non-reactive for anti-EA-D IgG) |
| Correlation (Manual vs. MAGO Plus) | Pearson Correlation Coefficient: 0.989 (Based on 193 serum samples) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 184 frozen retrospective sera for clinical sensitivity and specificity.
- Data Provenance: The sera were retrospectively collected and "characterized as research frozen retrospective sera." The document does not specify the country of origin, only stating it was tested by "an independent clinical commercial laboratory." It is retrospective data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify that "experts" were used to establish the ground truth in the traditional sense of a human review panel. Instead, the sera were "characterized" based on a combination of different EBV serologies.
- No explicit number of experts is mentioned.
- No qualifications of experts are provided.
4. Adjudication Method for the Test Set
There was no adjudication method described. The "ground truth" (EBV serological status) was established by characterizing the sera based on results from other EBV serologies (VCA IgG, VCA IgM, EBNA IgG, heterophile antibody), not through a human consensus or adjudication process for the test device itself.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic (IVD) assay (ELISA), which measures biochemical markers and thus does not involve human readers interpreting images or data alongside an AI.
6. Standalone (Algorithm Only) Performance
Yes, the study primarily describes the standalone performance of the "Is-EBV-EA-D IgG ELISA Kit" as an in-vitro diagnostic test. There is no "human-in-the-loop" component described for interpreting the ELISA results themselves beyond the technician performing the test and reading the absorbance values to calculate an index value, which then falls into predefined interpretative ranges (negative, equivocal, positive). The "MAGO Plus Automated Processor" is mentioned as an automated way to run the assay, but it automates the physical assay steps, not interpretive steps.
7. Type of Ground Truth Used
The ground truth used was EBV Serological Status, established by testing the sera with a panel of other established EBV serologies (VCA IgG, VCA IgM, EBNA IgG, heterophile antibody). This is a form of reference standard data based on established diagnostic tests for Epstein-Barr Virus infection. It is not pathology, expert consensus on the device's output, or outcomes data.
8. Sample Size for the Training Set
The document does not describe a "training set" in the context of an algorithm or machine learning device. This is an ELISA kit, a traditional biochemical assay. Therefore, there is no explicit training set as would be found in AI/ML device development. The assay's parameters would have been developed and optimized internally by the manufacturer, but this is not typically referred to as a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
As there is no described training set for an algorithm, the concept of establishing ground truth for a training set does not apply directly. The development of the ELISA kit itself relies on established serological principles and reagents (e.g., recombinant EA-D antigen), with internal validation studies conducted during development to optimize its performance, but this is distinct from establishing ground truth for an AI/ML training set.
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2/16/99
IMMUNO PROBE 301695782
K98183/
37 Page 3/8
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: K981831
Applicant Information
Sent by:
| Date Prepared: | May 18, 1998 |
|---|---|
| Name: | Columbia Bioscience, Inc. |
| Address: | 8775 M Centre Park Drive, #559Columbia, MD 21045 |
| Contact Person: | Norman Jenkins |
|---|---|
| PhoneNumber: | 410-995-1278 |
| Fax Number | 410-995-0508 |
Device Information:
| Trade Name: | Image: logo EBV EA-D IgG ELISA Kit |
|---|---|
| Common Name: | EBV Early Antigen EIA Test |
| Classification Name; | Epstein Barr Virus Serological Reagent |
Equivalent Device Description:
Wampole EA-D IgG ELISA.
Wampole EA-D IgG ELISA kit contains instructions and materials for the qualitative and semi-quantitative detection of IgG antibodies to EBV-EA-D IgG in human serum by indirect ELISA
Device Description: The & EBV-EA-D IgG ELISA Kit is an enzyme-linked immunosorbent assay (EUSA) for the detection of IgG to Epstein Barr Early Antigen diffuse in human serum.
Intended Use: For the qualitative and semi-quantitative determination of 14G antibodies to Epstein-Barr Virus (recombinant) Early Antigen Diffuse (EBV-EA-D IgG) in human serum by indirect enzyme immunoassay The Is-EBV-EA-D 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 (EA-D) IgG and IgM, Early Antigen-Diffuse (EA-D) IgM and heterophile antibody as an aid in the diagnosis of infectious mononucleosis (IM) The evaluation of paired sera, to deter-mine a significant increase in EA-D 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 EA-D antigen is bound to microwells. Diluted patient sera, Cut-Off Calibrator and controls are placed inthe microwells and incubated. Anti-EA-D IgG antibodes, if present, will bind to the antigen forming antigen-antibody complexes. Residual sample is eliminated by aspirating, Conjugate (horseratish peroxidase-labeled anti-human IgG) is added and will bind to these complexes. Unbound connugate 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 450 nm (reference 600-6.30 nm) and is directly proportional to the concentration of IgG antibodies to EA-1) present in the sample.
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The Is-EBV-EA-D IgG ELISA kit and the Wampole EA-D IgG ELISA are substantially equivalent in that
- Both are in vitro immunologic methods. ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
- Both are intended for use in the detection of IgG antibody to EBV-EA-D in human serum 2.
- Both are based on the formation of a complex between EA-D antigens and antibody ﻟﺪ
- Both use antigen coated microtiter plates. 4
- Both use goat anti-human lgG conjugated to horseradish peroxidase 5
- Both use TMB as the enzyme substrate (s
A detailed comparison between the proposed devise and the predicate device is shown in Table 1.
Conclusions: The Diamedix Is-EBV-EA-D IgG is substantially equivalent to the Wampole EA-D ELISA for the detection of IgG antibodies to EBV-EA-D 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-EA-D IgG ELISA Kit | PREDICATE DEVICEWampole EA-D IgG ELISA | |
| Intended Use | For the qualitative and semi-quantitative determination of IgGantibodies to Epstein-Barr Virus (recombinant) Early AntigenDiffuse (EBV-EA-D IgG) in human serum by indirect enzymeimmunoassay. The Is-EBV-EA-D IgG Test Kit may be used incombination with other Epstein-Barr serologies (Viral CapsidAntigen (VCA) IgG and IgM , Epstein-Barr Nuclear Antigen-1(EA-D) IgG and IgM, Early Antigen-Diffuse (EA-D) IgM andheterophile antibody as an aid in the diagnosis of infectiousmononucleosis (IM). The evaluation of paired sera, to deter-mine a significant increase in EA-D IgG antibody titer, can alsoaid in the diagnosis of acute infection. These reagents can beused either manually or in conjunction with the MAGO® PlusAutomated Processor | The Epstein-Bart Early Antigen Diffuse component (FA-D) IgG kit is an Enzyme-Linked ImmunoSorbent Assay(ELISA) for the qualitative determination of IgGantibodies in human serum to EA-D antigen. TheWampole anti-EA-D assay may be used in conjunctionwith other Epstein-Bart serologies (VCA IgG, VCA IgM.EBNA-1 IgG, EBNA-1 IgM, and heterophile) as an and 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. Assayperformed 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 frzenhuman serum. Assay performed on 1:21 dilution ofserum at 21-25°C. Store at 2-8°C. |
| Design | Is-EBV-EA-D IgG Test Kit. 96 determinations. Un-dilutedCalibrator, Positive, and Negative controls. | EA-D IgG ELISA. 96 determinations. UndilutedCalibrator, High positive, Low positive, and Negativecontrols. |
| Principles ofOperation | Purified, recombinant EA-D antigen is bound to microwells(solid phase). Diluted human serum is asses to the microwellwhich binds human anti-EA-D IgG, if present. Solid phase iswashed and exposed to anti-human IgG conjugate. Solid phaseis washed and exposed to enzyme substrate to develop color.Strong acid is added to stop reaction. The color is read at450/600 nm on an EIA render. | Diluted patient serum is incubated with purified,recombinant EA-D antigen bound to the solid surface of amicrotiter well. If IgG antibodies against EBV-EA-D arepresent in the serum, antigen-antibody complexes areformed. These complexes bind with HRP-labeled anti-human IgG which react with the addition of chromogen,resulting in a color development. The absorbance ismeasured at 450/630 nm. |
| PerformanceCharacteristics | Relative Sensitivity (Late Infection): 81.8%Relative Sensitivity (Current Infection): 28.1%Relative Specificity (Convalescent): 89.7%Relative Specificity (Seronegative): 100.0%Agreement: 79.9%Intra-assay Precision (Positive samples, all sites)Overall Manual- 2.07-13.88 MAGO Plus- 1.77-18.00Interassay Precision (Positive samples, all sites)Overall Manual- 5.12-9.08 MAGO Plus- 5.09-11.61No Cross-reactivity | Relative Sensitivity (Late Acute): 100.0%Relative Specificity (Seronegative): 100.0%Relative Specificity (Early Acute): 97.0%Relative Sensitivity (Seropositive): 19.7%Relative Specificity (Seropositive): 80.3%Agreement: 85.6%Inter-Site Precision (Positive samples, all sites)Overall: 5.96-8.83%No Cross-reactivity |
| Enzyme Used | Horseradish Peroxidase | Horseradish Peroxidase |
| Substrate | TMB | TMB |
| Specimen | Serum | Serum |
| Calculation ofResults | Sample Absorbance/Cut-off Absorbance = Index Value | Sample Absorbance/Cut-off Absorbance = ISR |
| Interpretation | <0.90 Negative0.91-1.09 Equivocal>=1.10 Positive | <0.90 Negative for EA-D IgG0.91-1.09 Equivocal for EA-D IgG>= 1.10 Positive for EA-D 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
Frozen retrospective sera from one hundred and eighty four pations welce climaterized as the research Frozen redospective sers from one named and cigity four patibodies. Hased on the results of this testing, the patient sera were characterized as follows :
- · 102 sera were characterized as past infection. These were positive for VCA IgG 102 Sera Were Characterized is past inrection. VCA IgM and heterophile antibody.
- · 34 sera were characterized as scronegative. These were negative for VCA IgG, VCA IgM, EUNA IgG and heterophile antibody.
- · 37 sera were characterized as having a current (recent) infection. These were positive for VCA IgM and/or heterophile antibody and were negative for EBNA IgC.
- · 11 seta were characterized as having a transitional infection. These were positive for VCA IgM and/or ticterophile antibody and were positive for EBNA IgG.
All 184 sera were then tested by an independent clinical commorcial laboratory using the Is-ElBV-EA-D IgG Test Kit. The results obtained are shown in Table 2:
| TABLE 2 | EBV Serological Status | Past Infection | Current Infection | Transitional | Seronegative | |
|---|---|---|---|---|---|---|
| Is-EBV-EA-D IgG | POSITIVE | 10 | 9 | 9 | 0 | |
| NEGATIVE | 87 | 23 | 2 | 34 | ||
| *EQUIVOCAL | 5 | 5 | 0 | 0 |
| FBV Serological Stat |
|---|
- · Of the 102 past infection sera tested, 87 were negative for anti-EA-D IgG, ten were positive, and five were equivocal.
- · Of the thirty-seven current (recent) infection samples tested, twenty-three were negative for anti-LA-1) IgG, nine were positive, and five were equivocal.
- · Of the cleven transitional intection sera tested, nine were positive for EAD IgG and two were negative,
- · Of the thirty-four seronegative sera tested, thirty-four were negative for anti-EA-D IgG.
- · The overall agreement of the Is-EBV-EA-DIgG test kit compared to EBV serological status was 1391174 == 79.9%.
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B. Precision
To determine the precision of the Is-EBV-EA-D IgG Test Kit, four positive and two negative sera were siste its is young w To decembile the precision of the IS-ED V-EX-D Tish Not four roduction of the is a greation 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 1MEAN INDEX | INTRA-ASSAY RUN 1CV% | INTRA-ASSAY RUN 2MEAN INDEX | INTRA-ASSAY RUN 2CV% | INTRA-ASSAY RUN 3MEAN INDEX | INTRA-ASSAY RUN 3CV% | INTERASSAYMEAN INDEX | INTERASSAYCV% |
|---|---|---|---|---|---|---|---|---|
| A (POS) | 1.88 | 4.97 | 1.79 | 5.61 | 1.77 | 6.28 | 1.01 | 6.03 |
| B (POS) | 2.55 | 6.77 | 2.42 | 5.11 | 2.25 | 6.54 | 2.41 | 7.87 |
| C (POS) | 2.21 | 6.87 | 2.18 | 4.76 | 2.02 | 4.26 | 2.14 | 6.59 |
| D (POS) | 1.17 | 5.11 | 1.17 | 13.08 | 1.15 | 6.49 | 1.16 | 9.08 |
| E (NEG) | 0.18 | 13.02 | 0.16 | 30.06 | 0.16 | 18.13 | 0.17 | 21.00 |
| F (NEG) | 0.27 | 10.26 | 0.27 | 11.97 | 0.28 | 15.93 | 0.27 | 12.87 |
| CAL | 0.97 | 12.06 | ||||||
| FC | 1.53 | 4.89 | ||||||
| NC | 0.30 | 5.04 |
TABLE 4 : Site #2- Intra-Assay and Interassay Precision
| 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) | 1.77 | 5.18 | 1.84 | 2.07 | 1.70 | 3.99 | 1.77 | 5.12 |
| B (POS) | 2.54 | 4.41 | 2.60 | 3.75 | 2.28 | 2.83 | 2.47 | 6.73 |
| C (POS) | 2.27 | 5.41 | 2.32 | 4.62 | 2.05 | 4.34 | 2.21 | 7.08 |
| D (POS) | 1.34 | 3.70 | 1.23 | 4.24 | 1.16 | 3.45 | 1.24 | 7.23 |
| E (NEG) | 0.23 | 6.31 | 0.22 | 5.98 | 0.20 | 5.43 | 0.22 | 7.79 |
| F (NEG) | 0.34 | 5.60 | 0.30 | 6.71 | 0.31 | 9.76 | 0.32 | 8.91 |
| CAL | 1.00 | 4.77 | ||||||
| FC | 1.62 | 4.49 | ||||||
| NC | 0.36 | 12.16 |
| TABLE 5 : Site #3 - 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) | 1.70 | 6.98 | 1.70 | 2.68 | 1.86 | 4.15 | 1.70 | 6.05 |
| B (POS) | 2.42 | 4.47 | 2.57 | 3.77 | 2.66 | 3.01 | 2.55 | 5.32 |
| C (POS) | 2.15 | 3.05 | 2.19 | 5.29 | 2.33 | 3.86 | 2.22 | 5.39 |
| D (POS) | 1.13 | 6.81 | 1.12 | 5.78 | 1.13 | 7.23 | 1.12 | 6.43 |
| E (NEG) | 0.18 | 10.78 | 0.20 | 11.33 | 0.19 | 10.23 | 0.19 | 11.38 |
| F (NEG) | 0.28 | 8.75 | 0.34 | 37.55 | 0.32 | 11.78 | 0.31 | 25.10 |
| CAL | 1.00 | 2.60 | ||||||
| HC | 1.54 | 12.50 | ||||||
| NC | 0.32 | 2.60 |
C. Specificity with Potentially Cross-Reactive Sera
Sixteen sera, non-reactive (negative) for IgG antibotics to EA-D In the Is-EBV-EA-D IgG Test Kit, were tested by EIA for IgG antibody to variedla zoster, cytomegalovirus and herpes simplex virus. 15/15 ami-VZV IgG positive sera were son-reactive for anti-EA-D IgG; 3/3 anti-CMV IgG positive sera were non-reactive for anti-EA-D IgG and 3/3 anti-USV positive sers were non-reactive for anti-EA-D IgG. This suggests that no spectivity should be expected with the Is-EBV-EA-D IgG Test Kit from these analytes.
D. Correlation of Manual and MAGO Plus Results
The Is-EBV-EA-D LgG Test Kit has been developed for automated as well as manual use. To demonstrate the cquivalence of the manual and MAGO Plus procedures, the results of 193 serum samples tested by both methods were plotted. A scattergram and regression line of the results obtained with 95% confidence interval is shown in Fiven 3. The data indicate good correlation with a Pearson Correlation Coofficient of 0.989.
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Image /page/5/Figure/3 description: The image is a title for a figure. The title is "FIGURE 3 : Manual and MAGO Plus Result Correlation". The title indicates that the figure will show the correlation between manual results and MAGO Plus results. The figure is likely a graph or chart that compares the two sets of results.
Image /page/5/Figure/4 description: The image is a scatter plot comparing 'MAGO PLUS INDEX VALUES' on the y-axis and 'MANUAL INDEX VALUES' on the x-axis. The data points are clustered tightly around a linear trend. A regression line is plotted through the data, with the equation 'Y = -0.0197 + 1.0420 X' displayed at the top. The correlation coefficient 'r' is given as 0.989, indicating a strong positive linear relationship between the two variables.
D. MAGO Plus Precision
The precision of the assay when performed on the MAGO Plus Automated EIA Processor was determined by The precision of the user who performed en ans. Table 6 shows the interassily precision obtained using the MAGO Plus.
| SERUM | INTRA-ASSAY RUN 1 | INTRA-ASSAY RUN 2 | INTRA-ASSAY RUN 3 | INTERASSAY | ||||
|---|---|---|---|---|---|---|---|---|
| MEANINDEX | CV% | MEANINDEX | CV% | MEANINDEX | CV% | MEANINDEX | CV% | |
| A (POS) | 1.79 | 1.77 | 1.98 | 2.13 | 1.84 | 3.80 | 1.87 | 5.09 |
| B (POS) | 2.30 | 2.90 | 2.59 | 2.85 | 2.40 | 3.40 | 2.43 | 5.83 |
| C (POS) | 2.15 | 3.95 | 2.35 | 3.01 | 2.13 | 3.87 | 2.21 | 5.74 |
| D (POS) | 1.20 | 18.00 | 1.35 | 5.24 | 1.25 | 5.66 | 1.27 | 11.61 |
| E (NEG) | 0.20 | 0.00 | 0.24 | 21.52 | 0.20 | 0.00 | 0.21 | 16.21 |
| F (NEG) | 0.33 | 20.45 | 0.37 | 10.24 | 0.31 | 18.31 | 0.34 | 19.86 |
| CAL | 0.99 | 5.35 | ||||||
| FC | 1.50 | 0.00 | ||||||
| NC | 0.33 | 17.32 |
TABLE 6 : Site #2- Intra-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 U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three lines forming its body and head. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
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
Re: K981831 Trade Name: Is EBV-EA-D 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 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: K981831
Device Name: EBV- EA-D IgG ELISA
Indications For Use: For the qualitative and semi-quantitative determination of IgG antibodies to Epstein-Barr Virus (recombinant) Early Antigen Diffuse (EBV-EA-D IgG) in human serum by indirect enzyme immunoassay. The Is-EBV-EA-D 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) IgG and IgM, Early Antigen-Diffuse (EA-D) 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 EA-D 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
Woody Dubois
Over-The Counter Use (Optional Format 1-2-96)
(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number K98/83/
§ 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).