DIAMEDIX IS-CMV IGG TEST SYSTEM
Device Facts
| Record ID | K981163 |
|---|---|
| Device Name | DIAMEDIX IS-CMV IGG TEST SYSTEM |
| Applicant | Diamedix Corp. |
| Product Code | LFZ · Microbiology |
| Decision Date | Sep 21, 1998 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3175 |
| Device Class | Class 2 |
Indications for Use
The Diamedix Is-CMV IgG an Enzyme Immunoassay (EIA) for the qualitative and semi-quantitative determination of IgG antibodies in human serum by EIA to aid in the assessment of the patient's immunological response to CMV and to determine the immune status of individuals, including females of child-bearing age. The evaluation of acute and convales of child-bearing age. The evaluation of aculture infection, reactivated infection, or resident of primary infection, reactiveled infection, or reinfection with CMV. These reagents can be used either manually or in conjunction with CMV. These reage Aulomated EIA Processor Aulomated EIA Processor.
Device Story
Is-CMV IgG Test System is an ELISA for detecting/semi-quantitating IgG antibodies to CMV in human serum. Partially purified CMV antigen is immobilized on microtiter wells; patient serum is added; if present, anti-CMV IgG binds to antigen. After washing, enzyme-labeled anti-human immunoglobulin conjugate is added, followed by substrate. Color intensity is measured photometrically, providing an indirect measure of specific antibody concentration. Used in clinical laboratories; performed manually or via MAGO Plus Automated EIA Processor. Results assist clinicians in assessing patient immune status and diagnosing CMV infection stages. Benefits include standardized, automated or manual assessment of CMV serology.
Clinical Evidence
Performance evaluated using 587 serum samples across three sites. Compared against other marketed EIA methods. Relative sensitivity ranged from 96.6% to 100%; relative specificity ranged from 87.8% to 100%. Overall agreement ranged from 97.0% to 99.0%. CDC serum panel testing showed 99% total agreement (100% positive/100% negative agreement). Precision studies (intra-assay and inter-assay) performed manually and on MAGO Plus processor. Linearity demonstrated across the reportable range.
Technological Characteristics
Enzyme-linked immunosorbent assay (ELISA). Solid phase: microtiter wells coated with partially purified CMV antigen. Detection: enzyme-labeled anti-human immunoglobulin conjugate and substrate. Measurement: photometric color intensity. Operation: manual or automated (MAGO Plus EIA Processor).
Indications for Use
Indicated for qualitative and semi-quantitative detection of IgG antibodies to CMV in human serum. Used to assess immunological response, determine immune status (including females of child-bearing age), and aid in diagnosis of primary, reactivated, or reinfection with CMV.
Regulatory Classification
Identification
Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.
Predicate Devices
- Incstar CMV IgG ELISA Kit
Submission Summary (Full Text)
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## 510(k) 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: _______________________________________________________________________________________________________________________________________________
#### Applicant Information:
| Date Prepared: | March 19, 1998 |
|----------------|-----------------------------------------|
| Name: | Diamedix Corporation |
| Address: | 2140 N. Miami Avenue<br>Miami, FL 33127 |
| Contact Person: | Dr. Lynne Stirling |
|-----------------|--------------------|
| Phone Number: | 305-324-2354 |
| Fax Number: | 305-324-2585 |
#### Device Information:
| Trade Name: | Is-CMV IgG Test System |
|----------------------|----------------------------------------------------|
| Common Name: | CMV EIA Test |
| Classification Name: | Enzyme linked immunosorbent assay, cytomegalovirus |
#### Equivalent Device: Incstar CMV IgG ELISA Kit
Device Description: The Is-CMV IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to CMV antigen in human serum
Intended Use: The assay is intended for use in detecting IgG antibodies to CMV antigen in human serum. The results of the assay can be used as an aid in the assessment of the patient's immunological response to CMV and, when evaluating paired sera, as an aid in the diagnosis of primary infection, reactivated infection or reinfection.
#### Principle of the Procedure:
The Is-CMV IgG Test System is an enzyme-linked immunosorbent assay to detect IgG to CMV in human serum. Partially purified CMV antigen is attached to a solid phase microtiter well. Diluted test sera are added to each well. If antibodies which recognize the CMV antigen are present in the patient sample they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. A'n enzyme labeled antihuman immunoglobulin (conjugate) is added to each test well. If antibody is present the enzyme-linked antibody will bind to it. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is then added to each well. If enzyme is present from the prior step, the reaction is stopped and the color intensity is measured photometrically producing an indirect measure of the specific antibody present in the patient sample.
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# SUMMARY OF SAFETY AND EFFECTIVENESS
## Performance Characteristics
### A. Comparison Testing
A total of five hundred and eighty seven sera were tested for the presence of CMV IgG antibodies using the Diamedix Is-CMV IgG Test Kit and two other marketed tests at two independent sites (site #1, Miami, FL and site #2, Salt Lake City, Utah) as well as at Diamedix Corp., Miami, FL (site #3). At site #3 testing was performed both manually and using the MAGO Plus Automated EIA Processor.
Site #1 tested 200 samples (26% fresh and 74% frozen). Samples were obtained from the S. Florida arca. Table 2 compares the results obtained for the Is-CMV IgG test kit and their currently used testing method.
Site #2 tested 178 samples (all fresh). Samples were obtained from the Mid-West area. Table 3 compares the results obtained for the Is-CMV IgG test kit and their currently used testing method.
| | | TABLE 2<br><i>Is-CMV IgG - Site #1</i> | | | | TABLE 3<br><i>Is-CMV IgG - Site #2</i> | | |
|--------------|-----------|----------------------------------------|----------|------------------------|-----------|----------------------------------------|----------|-----------------------|
| | | Positive | Negative | Equivocal | | Positive | Negative | Equivocal |
| Other<br>EIA | Positive | 146 | 1 | 1 | Positive | 113 | 4 | 2 |
| | Negative | 1 | 47 | 3 | Negative | 0 | 51 | 1 |
| | Equivocal | 0 | 1 | 0 | Equivocal | 0 | 6 | 1 |
| | | | | | | | | |
| | | Relative Sensitivity 146/147 = 99.3% | | 96.3-100.0<br>95% CI** | | Relative Sensitivity 113/117 = 96.6% | | 91.5-99.1<br>95% CI** |
| | | Relative Specificity 47/48 = 97.9% | | 88.9-99.9 | | Relative Specificity 51/51 = 100.0% | | 93.0-100.0 |
| | | Overall Agreement* 193/195 = 99.0% | | 96.3-99.9 | | Overall Agreement* 164/168 = 97.6% | | 94.0-99.3 |
For site#1, both discordant sera were negative when tested by a referee EIA. For site #2, the four discordant sera were negative when tested by a referee EIA.
Site #3 (Diamedix Corp.) tested 209 samples (all frozen) by the manual method and 206 of these samples (three being QNS) by the MAGO Plus method. Samples were obtained from S. Florida blood donors. Tables 4 and 5 compare the results obtained for the Is-CMV IgG test kit and another marketed EIA method.
| TABLE 4<br>Is-CMV IgG - Site #3 : Manual | | | TABLE 5<br>Is-CMV IgG - Site #3 : MAGO Plus | | | | |
|-----------------------------------------------------------------------------------------------------------------------|----------|----------|---------------------------------------------|---------------------------------------|----------|-----------|------------|
| | Positive | Negative | Equivocal | Positive | Negative | Equivocal | |
| Positive | 152 | 0 | 0 | 152 | 0 | 0 | |
| Other<br>EIA Negative | 3 | 50 | 1 | 6 | 43 | 2 | |
| Equivocal | 2 | 1 | 0 | 2 | 1 | 0 | |
| Relative Sensitivity 152/152 = 100.0% | | | 97.6-100.0 | Relative Sensitivity 152/152 = 100.0% | | | 97.6-100.0 |
| Relative Specificity 50/53 = 94.3% | | | 84.3-98.8 | Relative Specificity 43/49 = 87.8 % | | | 75.2-95.4 |
| Overall Agreement* 202/205 = 98.5% | | | 95.8-99.7 | Overall Agreement* 195/201 = 97.0 % | | | 93.6-98.9 |
| * equivocal results excluded from calculations<br>** 95% Confidence Intervals (CI) calculated by the Exact Method (7) | | | | | | | |
For site #3 (manual testing), two of the discordant sera were positive and the remaining sample was equivocal when tested by a referee EIA. For the six sera discordant when tested by the MAGO Plus, three were positive, two were negative and one was equivocal when tested by the referee ELA.
NOTE : Please be advised that 'relative' refers to the comparison of the assay's results to that of a similar assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison assay's accuracy to predict disease
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## B. Correlation of Manual and MAGO Results
The Is-CMV 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 160 serum samples tested in the comparison studies were plotted Forty-six highly reactive samples exceeded the reportable range and were excluded from this comparison. A scatergram and regression line of the results obtained with 95% confidence intervals is shown in figure 3.
Image /page/2/Figure/2 description: The image is a scatter plot titled "FIGURE 3: Manual vs MAGO Plus Correlation". The x-axis is labeled "MANUAL EU/ml" and ranges from 0 to 200. The y-axis is labeled "MAGO EU/ml" and ranges from 0 to 200. The plot shows a positive correlation between the two variables, with most of the data points clustered around a regression line. The slope of the regression line is 0.9415, the intercept is 4.6521, and the R-value is 0.9568.
# C. CDC Serum Panel Data
The following information was obtained wth the Centers for Disease Control and Prevention (CDC) serum panel for CMV serology assays which was tested by the Is-CMV IgG Test Kit both manufacturer mated to mated Processor. The results are presented as a means to convey further information on the performance of this assay with a masked characterized serum patel. Results were submitted to the periodmands of this assume This does not imply an endorsement of the assay by the CDC.
The panel consists of 66% positive and 34% negative samples. The Diamedix Is-CMV IgG test demonstrated 99% (99%) of 100) total agreement with the CDC results obtained by Diamedix, there was 100% (66 of 66) agreement with the positive results using both the manual and automated methods and 100% (66) agreement with the negative specimens using both the manual and automated methods.
#### D. Linearity
------
Several strongly positive serum specimens were dilutions were assayed, in duplicate, in the Is-CMV IgG Test Kit both manually and using the MAGO Plus Automated Processor. Representative lines regession graphs and scatted both mannelly with 95% confidence intervals are presented in Figures 4 and 5 for one patient sample tested both manually and intel in contractives and presented in Figures 4 and 5 for one of linearity throughout the reportable range of the assay when samples are tested either manally or by MAGO Plus.
Image /page/2/Figure/8 description: The image contains two graphs, 'Figure 4: Manual Linearity' and 'Figure 5: MAGO Plus Linearity'. Both graphs show a linear relationship between dilution (x-axis) and EU/ml (y-axis). Figure 4 has a slope of 272.68, a y-intercept of 2.90, and an R-value of 0.9944, while Figure 5 has a slope of 302.82, a y-intercept of 5.59, and an R-value of 0.9927.
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#### E. Semi-Quantitative Data
Serum pairs were obtained by preparing multiple two fold dilutions of several strongly positive sera. Ratios for dilutions representing a four-fold difference in antibody level were evaluated as a serum pair both manually and using the MAGO Plus. Overall, it was estimated that a 2.3- to 6.1 fold (mean 4.2-fold ) increase in Is-CMV IgG EU/ml values corrcsponded to a four-fold titer increase in CMV IgG antibody levels.
#### F. Cross Reactivity
Sera containing IgG antibodies to viruses potentially cross-reactive to CMV have been tested in the Is-CMV IgG Test Kit Forty-seven sera negative for antibodies to CMV in the Is-CMV IgG as well as in another marketed test but positive for one or more viruses were used. The data in the following table suggest that no cross-reactivity should be expected with the Is-CMV IgG Test Kit from these analytes.
| Analyte | CMV IgG | VZV IgG | HSV 1/2 IgG | Toxoplasma IgG | Rubella IgG | EBV IgG | Measles IgG |
|--------------------|---------|---------|-------------|----------------|-------------|---------|-------------|
| No.of Pos. Samples | 0 | 45 | 35 | 6 | 38 | 45 | 43 |
| TABLE<br>6 |
|------------|
|------------|
#### G. Precision
Six serum samples (two negative and four positive) as well as the10 EU/ml kit Standard and kit controls were tested in triplicate in three separate runs. The precision studies were performed manually at the two independent testing sites (site #1 and site #2 ) and at site #3 (Diamedix Corp.) both manually and using the MAGO Plus Automated Processor. The results obtained are shown in Tables 7-10.
| TABLE 7 : Site #1- Intra-Assay and Interassay Precision | | |
|---------------------------------------------------------|-------------------|-------------------|
| SERUM | INTRA-ASSAY DAY 1 | INTRA-ASSAY DAY 2 |
| SERUM | INTRA-ASSAY DAY 1 | | | INTRA-ASSAY DAY 2 | | | INTRA-ASSAY DAY 3 | | | INTERASSAY | | |
|--------|-------------------|-------|-------|-------------------|------|-------|-------------------|------|-------|------------|------|-------|
| | MEAN | SD | CV% | MEAN | SD | CV% | MEAN | SD | CV% | MEAN | SD | CV% |
| A | 5.0 | 3.76 | 75.20 | 4.1 | 2.11 | 51.46 | 4.1 | 2.12 | 51.71 | 4.4 | 2.44 | 55.45 |
| B | 4.7 | 0.44 | 9.36 | 4.9 | 0.31 | 6.33 | 4.8 | 0.26 | 5.42 | 4.8 | 0.31 | 6.46 |
| C | 28.5 | 7.09 | 24.88 | 21.6 | 2.02 | 9.35 | 21.9 | 2.20 | 10.05 | 24.0 | 5.12 | 21.33 |
| D | 39.4 | 9.88 | 25.08 | 38.2 | 3.81 | 9.97 | 38.9 | 3.97 | 10.21 | 36.8 | 5.68 | 14.64 |
| E | 55.0 | 0.31 | 0.56 | 61.1 | 1.40 | 2.29 | 62.6 | 1.38 | 2.20 | 59.6 | 3.59 | 6.02 |
| F | 139.3 | 7.61 | 5.46 | 138.6 | 6.41 | 4.62 | 141.9 | 6.43 | 4.53 | 139.9 | 6.11 | 4.37 |
| 10 STD | 11.5 | 1.76 | 15.30 | 10.2 | 1.13 | 11.08 | 10.1 | 1.16 | 11.49 | 10.6 | 1.36 | 12.83 |
| HPC | 114.6 | 12.88 | 11.24 | 107.2 | 5.20 | 4.85 | 109.9 | 5.40 | 4.91 | 110.6 | 8.13 | 7.35 |
| LPC | 25.0 | 1.70 | 6.80 | 23.9 | 2.17 | 9.08 | 24.3 | 2.25 | 9.26 | 24.4 | 1.85 | 7.58 |
| NC | 3.1 | 0.23 | 7.42 | 2.6 | 0.25 | 9.62 | 2.7 | 0.31 | 11.48 | 2.8 | 0.33 | 11.79 |
TABLE 8 : Site #2 - Intra-Assay and Interassay Precision
| SERUM | INTRA-ASSAY DAY 1 | | | INTRA-ASSAY DAY 2 | | | INTRA-ASSAY DAY 3 | | | INTERASSAY | | |
|--------|-------------------|-------|-------|-------------------|------|-------|-------------------|------|-------|------------|------|-------|
| | MEAN | SD | CV% | MEAN | SD | CV% | MEAN | SD | CV% | MEAN | SD | CV% |
| A | 3.8 | 0.40 | 10.53 | 3.0 | 0.74 | 24.67 | 2.5 | 0.44 | 17.60 | 3.1 | 0.75 | 24.19 |
| B | 4.7 | 0.06 | 1.28 | 3.3 | 0.81 | 24.55 | 3.8 | 0.87 | 22.89 | 4.0 | 0.86 | 21.50 |
| C | 14.1 | 1.75 | 12.41 | 14.2 | 3.41 | 24.01 | 17.2 | 0.31 | 1.80 | 15.2 | 2.44 | 16.05 |
| D | 30.0 | 3.44 | 11.47 | 27.8 | 1.10 | 3.96 | 23.5 | 3.05 | 12.98 | 27.1 | 3.70 | 13.65 |
| E | 60.5 | 8.38 | 13.85 | 45.2 | 2.00 | 4.42 | 43.7 | 2.26 | 5.17 | 49.8 | 9.23 | 18.53 |
| F | 96.3 | 12.92 | 13.42 | 97.8 | 6.27 | 6.41 | 92.3 | 0.95 | 1.03 | 95.5 | 7.60 | 7.96 |
| 10 STD | 9.4 | 1.21 | 12.87 | 9.7 | 1.04 | 10.72 | 8.3 | 1.74 | 20.95 | 9.1 | 1.35 | 14.84 |
| HPC | 85.7 | 2.47 | 2.88 | 89.0 | 3.06 | 3.43 | 84.9 | 2.09 | 2.46 | 86.6 | 2.95 | 3.41 |
| LPC | 22.5 | 1.58 | 7.02 | 22.5 | 1.60 | 7.11 | 20.4 | 2.20 | 10.78 | 21.8 | 1.91 | 8.76 |
| NC | 3.0 | 0.42 | 14.00 | 3.1 | 0.10 | 3.23 | 2.8 | 0.12 | 4.12 | 3.0 | 0.25 | 8.33 |
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TABLE 9 : Site #3 Intra-Assay and Interassay Precision (Manual)
| SERUM | INTRA-ASSAY DAY 1 | | | INTRA-ASSAY DAY 2 | | | INTRA-ASSAY DAY 3 | | | INTERASSAY | | |
|--------|-------------------|-------|-------|-------------------|------|-------|-------------------|-------|-------|------------|-------|-------|
| | MEAN | SD | CV% | MEAN | SD | CV% | MEAN | SD | CV% | MEAN | SD | CV% |
| A | 2.2 | 1.64 | 74.54 | 1.9 | 0.56 | 29.47 | 1.8 | 0.60 | 33.33 | 2.0 | 1.01 | 50.50 |
| B | 3.9 | 1.85 | 47.44 | 2.8 | 0.94 | 33.57 | 3.5 | 0.49 | 14.00 | 3.4 | 1.25 | 36.76 |
| C | 10.0 | 0.75 | 7.50 | 9.5 | 0.59 | 6.21 | 10.5 | 0.94 | 8.95 | 10.0 | 0.86 | 8.60 |
| D | 26.4 | 1.69 | 6.40 | 25.8 | 2.59 | 10.04 | 28.6 | 1.00 | 3.50 | 26.9 | 2.14 | 7.96 |
| E | 45.9 | 7.47 | 16.27 | 43.0 | 4.21 | 9.79 | 46.1 | 6.41 | 13.90 | 45.0 | 6.00 | 13.33 |
| F | 99.1 | 4.61 | 4.65 | 92.7 | 7.61 | 8.21 | 100.5 | 3.88 | 3.86 | 97.4 | 6.32 | 6.49 |
| 10 STD | 9.6 | 1.05 | 10.94 | 9.2 | 0.67 | 7.28 | 9.9 | 0.59 | 5.96 | 9.6 | 0.81 | 8.44 |
| HPC | 96.1 | 12.08 | 12.57 | 94.7 | 9.67 | 10.21 | 96.6 | 11.66 | 12.07 | 95.8 | 10.54 | 11.00 |
| LPC | 24.9 | 2.53 | 10.16 | 24.0 | 0.88 | 3.67 | 25.6 | 1.34 | 5.23 | 24.8 | 1.76 | 7.10 |
| NC | 3.5 | 0.64 | 18.29 | 3.6 | 0.44 | 12.22 | 3.6 | 0.29 | 8.06 | 3.6 | 0.45 | 12.50 |
TABLE 10 : Site #3 Intra-assay and Interassay Precision (MAGO Plus)
| SERUM | INTRA-ASSAY DAY 1 | | | INTRA-ASSAY DAY 2 | | | INTRA-ASSAY DAY 3 | | | INTERASSAY | | |
|--------|-------------------|------|-------|-------------------|------|-------|-------------------|------|-------|------------|-------|-------|
| | MEAN | SD | CV% | MEAN | SD | CV% | MEAN | SD | CV% | MEAN | SD | CV% |
| A | 2.8 | 0.74 | 26.42 | 2.8 | 0.96 | 34.28 | 3.3 | 0.43 | 13.03 | 3.0 | 0.74 | 24.67 |
| B | 4.1 | 0.45 | 10.98 | 4.3 | 0.56 | 13.02 | 3.8 | 0.56 | 14.74 | 4.1 | 0.54 | 13.17 |
| C | 14.0 | 3.11 | 22.21 | 15.5 | 1.13 | 7.29 | 14.1 | 0.76 | 5.39 | 14.5 | 1.97 | 13.59 |
| D | 31.2 | 4.59 | 14.71 | 34.1 | 4.00 | 11.73 | 35.8 | 6.47 | 18.07 | 33.7 | 5.21 | 15.46 |
| E | 50.5 | 4.65 | 9.21 | 56.5 | 4.37 | 7.73 | 55.1 | 6.01 | 10.91 | 54.0 | 5.44 | 10.07 |
| F | 102.8 | 4.88 | 4.75 | 115.1 | 9.30 | 8.07 | 121.5 | 7.64 | 6.29 | 113.1 | 10.67 | 9.43 |
| 10 STD | 10.3 | 1.36 | 13.20 | 10.3 | 0.77 | 7.48 | 11.9 | 0.68 | 5.71 | 10.8 | 1.19 | 11.02 |
| HPC | 108.6 | 8.67 | 7.98 | 109.5 | 3.69 | 3.37 | 111.9 | 9.38 | 8.38 | 110.0 | 7.35 | 6.68 |
| LPC | 30.2 | 3.46 | 11.46 | 32.1 | 2.70 | 8.41 | 30.1 | 1.52 | 5.05 | 30.8 | 2.70 | 8.77 |
| NC | 3.2 | 0.95 | 29.69 | 3.2 | 0.55 | 17.19 | 3.1 | 0.70 | 22.58 | 3.2 | 0.71 | 22.19 |
### H. Expected Values
The prevalence of CMV antibodies in the normal population can vary deponding on a number of factors such as age, geographical location, socio-economic status, race and type of test used. Sera from 100 healthy South Florida donors (52 female and 48 male) were evaluated in the Is-CMV IgG test Kit. Of the 100 seathy South
Florida donors (52 female and 48 male) were evaluated in the Is-CMV were found to be positive, 29 were negative and 1 was equivocal for anti-CMV igG. The resulting provalence of 70% for this population is in general agreement with prevalence rates of 30% to 80% in US blood donors (2). Age distribution, geographic is and prevalence is provided in Table 1. Histograms demonstrating the distribution of EU/ml values are shown in Figures 1 and 2.
| TABLE 1 | | |
|----------------------------------------------|------------------|------------|
| | Number of donors | Prevalence |
| Total Number | 100% | 70% |
| Geographic<br>location :<br>South Eastern US | 100 | 70% |
| Age<br>10-19 | 13 | 38.5% |
| 20-29 | 23 | 69.6% |
| 30-39 | 40 | 67.5% |
| 40-49 | 13 | 76.9% |
| 50-59 | 5 | 100% |
| 60-69 | 6 | 100% |
Ω and
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Image /page/5/Figure/0 description: The image contains two bar charts, labeled as Figure 1 and Figure 2. Figure 1, titled "Is-CMV IgG Positive Population," displays frequency on the y-axis and EU/mL on the x-axis, with categories 0-10, 11-40, 41-80, 81-120, 121-160, and >160. Figure 2, titled "Is-CMV IgG Negative Population," also displays frequency on the y-axis and EU/ml on the x-axis, with categories 0-2, 3-5, 6-8, and 9-10. The frequency values vary across the categories in both charts, showing the distribution of positive and negative populations.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font. The words are arranged horizontally, with "Public" and "Health" on the first line and "Service" on the second line.
Image /page/6/Picture/2 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol resembles a stylized eagle or bird with three curved lines forming its body and wings. The overall design is simple and conveys a sense of government authority and public service.
### SEP 2 | 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Lynne Stirling, Ph.D. Vice President, Regulatory Affairs Diamedix Corp. 2140 N. Miami Avenue Miami, FL 33127
Rc: K981163
Trade Name: Diamedix Is-CMV IgG Test System Regulatory Class: II Product Code: LF7. Dated: July 6, 1998 Received: July 7, 1998
Dear Dr. Stirling:
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 rood, Erag, and 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, FIDA 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 scetions 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 labcling 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 frec number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincercly 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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ATTACHMENT 1
# Appendix G Rev. Indications for Use Statement
# INDICATIONS FOR USE STATEMENT
### 510(K) NUMBER : _ K 98 11 63
# DEVICE NAME : Is-CMV IgG Test System
Indications for Use : The Diamedix Is-CMV IgG an Enzyme Immunoassay (EIA) for the qualitative and semi-quantitative determination of IgG antibodies in human serum by EIA to aid in the assessment of the patient's immunological response to CMV and to determine the immune status of individuals, including females of child-bearing age. The evaluation of acute and convales of child-bearing age. The evaluation of aculture
infection, reactivated infection, or resident of primary infection, reactiveled infection, or reinfection with CMV. These reagents can be used either manually or in conjunction with CMV. These reage
Aulomated EIA Processor Aulomated EIA Processor.
Woody Dubois
(Division Sigt/Off)
Division of Clinical Laboratory Devices
510(k) Numbeı K981163
#### 0000099
