(270 days)
Wampole EA-D IgG ELISA
Not Found
No
The device description and performance studies focus on a standard ELISA assay and an automated processor, with no mention of AI or ML.
No.
This device is an in vitro diagnostic test for the detection of antibodies to a virus, which aids in diagnosis rather than directly treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "may be used in combination with other Epstein-Barr serologies... as an aid in the diagnosis of infectious mononucleosis (IM)." This indicates its purpose is to help physicians diagnose a medical condition.
No
The device description clearly outlines a physical ELISA kit with reagents, microwells, and a process involving incubation, washing, and spectrophotometric reading. While it mentions potential use with an automated processor (MAGO® Plus), the core device is a hardware-based immunoassay kit, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the qualitative and semi-quantitative determination of IgG antibodies to Epstein-Barr Virus... in human serum by indirect enzyme immunoassay." This describes a test performed on a sample taken from the human body (serum) to provide information about a medical condition (presence of antibodies to EBV).
- Device Description: The description details an "enzyme-linked immunosorbent assay (ELISA)" which is a common laboratory technique used for in vitro diagnostic testing. It describes the process of using reagents to detect the presence of antibodies in a sample.
- Aid in Diagnosis: The intended use also states that the kit "may be used in combination with other Epstein-Barr serologies... as an aid in the diagnosis of infectious mononucleosis (IM)." This clearly indicates its role in providing diagnostic information.
These points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures.
N/A
Intended Use / 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 (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.
Product codes (comma separated list FDA assigned to the subject device)
GNP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
-
Clinical Sensitivity and Specificity Using Characterized Sera:
- Sample Size: 184 sera
- Key Results:
- 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 139/174 == 79.9%.
-
Precision:
- Study Type: Intra-assay and Interassay Precision study across three sites.
- Sample Size: Four positive and two negative sera.
- Key Results: Detailed tables showing Mean Index and CV% for Intra-Assay Runs (1, 2, 3) and Interassay for each serum (A-F) at each site. No overall CV% range is explicitly stated, but individual CV% values range from approximately 1.77% to 37.55%.
-
Specificity with Potentially Cross-Reactive Sera:
- Sample Size: Sixteen sera.
- Key Results: 15/15 anti-VZV IgG positive sera were non-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. Suggests no cross-reactivity from these analytes.
-
Correlation of Manual and MAGO Plus Results:
- Study Type: Method correlation study.
- Sample Size: 193 serum samples.
- Key Results: Pearson Correlation Coefficient of 0.989, indicating good correlation.
-
MAGO Plus Precision:
- Study Type: Intra-assay and Interassay Precision study when performed on the MAGO Plus Automated EIA Processor.
- Sample Size: Six sera (4 positive, 2 negative).
- Key Results: Detailed tables showing Mean Index and CV% for Intra-Assay Runs (1, 2, 3) and Interassay. Interassay CV% values for positive samples range from 5.09% to 11.61%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- 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):
- Manual: 2.07-13.88
- MAGO Plus: 1.77-18.00
- Interassay Precision (Positive samples, all sites):
- Manual: 5.12-9.08
- MAGO Plus: 5.09-11.61
- No Cross-reactivity
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.
Wampole EA-D IgG ELISA
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
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, #559 |
| Columbia, 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.
1
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.
2
| Table 1 | ||
|---|---|---|
| PROPOSED DEVICE | ||
| Diamedix Is-EBV-EA-D IgG ELISA Kit | PREDICATE DEVICE | |
| Wampole EA-D IgG ELISA | ||
| Intended 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 | ||
| (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 | ||
| aid in the diagnosis of acute infection. These reagents can be | ||
| used either manually or in conjunction with the MAGO® Plus | ||
| Automated Processor | The Epstein-Bart Early Antigen Diffuse component (FA- | |
| D) IgG kit is an Enzyme-Linked ImmunoSorbent Assay | ||
| (ELISA) for the qualitative determination of IgG | ||
| antibodies in human serum to EA-D antigen. The | ||
| Wampole anti-EA-D assay may be used in conjunction | ||
| with other Epstein-Bart serologies (VCA IgG, VCA IgM. | ||
| EBNA-1 IgG, EBNA-1 IgM, and heterophile) as an and in | ||
| the 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 frzen | |
| human serum. Assay performed on 1:21 dilution of | ||
| serum at 21-25°C. Store at 2-8°C. | ||
| Design | Is-EBV-EA-D IgG Test Kit. 96 determinations. Un-diluted | |
| Calibrator, Positive, and Negative controls. | EA-D IgG ELISA. 96 determinations. Undiluted | |
| Calibrator, High positive, Low positive, and Negative | ||
| controls. | ||
| Principles of | ||
| Operation | Purified, recombinant EA-D antigen is bound to microwells | |
| (solid phase). Diluted human serum is asses to the microwell | ||
| which binds human anti-EA-D IgG, if present. Solid phase is | ||
| washed and exposed to anti-human IgG conjugate. Solid phase | ||
| is washed and exposed to enzyme substrate to develop color. | ||
| Strong acid is added to stop reaction. The color is read at | ||
| 450/600 nm on an EIA render. | Diluted patient serum is incubated with purified, | |
| recombinant EA-D antigen bound to the solid surface of a | ||
| microtiter well. If IgG antibodies against EBV-EA-D are | ||
| present in the serum, antigen-antibody complexes are | ||
| formed. These complexes bind with HRP-labeled anti- | ||
| human IgG which react with the addition of chromogen, | ||
| resulting in a color development. The absorbance is | ||
| measured at 450/630 nm. | ||
| Performance | ||
| Characteristics | 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- 1.77-18.00 | ||
| Interassay Precision (Positive samples, all sites) | ||
| Overall Manual- 5.12-9.08 MAGO Plus- 5.09-11.61 | ||
| No 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 of | ||
| Results | Sample Absorbance/Cut-off Absorbance = Index Value | Sample Absorbance/Cut-off Absorbance = ISR |
| Interpretation | =1.10 Positive | = 1.10 Positive for EA-D IgG |
| Materials | 96 microwells in 12x8 strips, Wash concentrate, Sample | |
| Diluent, Conjugate, Calibrator, Controls, Substrate, Stop | ||
| Solution | 96 microwells in 12x8 strips, Wash Buffer, Serum | |
| Diluent, HRP Conjugate, Calibrator, Controls, | ||
| Chromogen, Stop Solution. |
3
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%.
4
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 1
MEAN INDEX | INTRA-ASSAY RUN 1
CV% | INTRA-ASSAY RUN 2
MEAN INDEX | INTRA-ASSAY RUN 2
CV% | INTRA-ASSAY RUN 3
MEAN INDEX | INTRA-ASSAY RUN 3
CV% | INTERASSAY
MEAN INDEX | INTERASSAY
CV% |
|---------|---------------------------------|--------------------------|---------------------------------|--------------------------|---------------------------------|--------------------------|--------------------------|-------------------|
| 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 | ||||
|---|---|---|---|---|---|---|---|---|
| MEAN | ||||||||
| INDEX | CV% | MEAN | ||||||
| INDEX | CV% | MEAN | ||||||
| INDEX | CV% | MEAN | ||||||
| INDEX | 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.
5
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 | ||||
|---|---|---|---|---|---|---|---|---|
| MEAN | ||||||||
| INDEX | CV% | MEAN | ||||||
| INDEX | CV% | MEAN | ||||||
| INDEX | CV% | MEAN | ||||||
| INDEX | 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
6
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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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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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/