(40 days)
The SeraQuest EBV EA-D IgG test is for the qualitative detection of human IgG antibodies to Epstein-Barr virus early antigen diffuse (EA-D) in human serum by enzyme immunoassay. This assay uses a 28 kd E. coli expressed recombinant Epstein-Barr virus early antigen. When performed in conjunction with other EBV serological tests, this assay can be used as an aid in the laboratory diagnosis of EBV infectious mononucleosis in patients with signs and symptoms of EBV infectious mononucleosis. For In Vitro Diagnostic Use Only.
The SeraQuest EBV EA-D IgG Test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against EBV Early Antigen D (EA-D), in human serum.
The document describes the SeraQuest EBV EA-D IgG Test, a solid-phase enzyme immunoassay (EIA) designed for the qualitative detection of human IgG antibodies to Epstein-Barr virus early antigen diffuse (EA-D) in human serum. This assay aids in the laboratory diagnosis of EBV infectious mononucleosis when used with other EBV serological tests.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds (e.g., "Positive Agreement must be >X%"). Instead, it presents various performance metrics derived from its clinical evaluation, which are then compared to a legally marketed predicate device. The implicit acceptance criterion appears to be "substantial equivalence" to the predicate device in terms of performance characteristics for diagnostic aid in EBV infectious mononucleosis.
The performance is reported in terms of percent agreement and associated confidence intervals, categorized by EBV serological status.
| EBV Serological Status | Performance Metric (SeraQuest EBV EA-D IgG Test) | Reported Value (Prospectively Collected & Tested) | 95% Confidence Interval (Prospectively Collected & Tested) | Reported Value (Retrospectively Tested) | 95% Confidence Interval (Retrospectively Tested) |
|---|---|---|---|---|---|
| Acute Infection | Positive Agreement | 54.8% (17/31) | 36.0-72.7% | 70.0% (35/50) | 55.4-82.1% |
| EBV Seronegative | Negative Agreement | 78.3% (47/60) | 65.8-87.9% | 86.7% (13/15) | 59.5-98.3% |
| Past Infection | Negative Agreement | 60.1% (187/311) | 54.7-65.6% | Not applicable (0 retrospectively tested past infection samples) | Not applicable |
Note: For comparison, the predicate device (Comparator EBV EA-D IgG Test) achieved:
- Acute Infection Positive Agreement: 41.9% (13/31) with CI 24.5-60.9% (prospectively tested)
- Acute Infection Positive Agreement: 64.0% (32/50) with CI 49.2-77.1% (retrospectively tested)
- EBV Seronegative Negative Agreement: 78.3% (47/60) with CI 65.8-87.9% (prospectively tested)
- No Infection Negative Agreement: 73.3% (11/15) with CI 44.9-92.2% (retrospectively tested)
- Past Infection Negative Agreement: 62.7% (195/311) with CI 57.3-68.1% (prospectively tested)
2. Sample Size Used for the Test Set and Data Provenance
- Total Test Set Sample Size: 542 serum samples.
- Prospectively Collected and Prospectively Tested: 477 samples.
- Prospectively Collected but Retrospectively Tested: 65 samples (50 acute specimens, 15 EBV seronegative).
- Data Provenance:
- Country of Origin: 3 U.S. clinical testing sites.
- Nature of Data: Mixed; primarily prospective (477 samples) with a supplementary retrospective component (65 samples that were prospectively collected but retrospectively tested). The study notes that the 65 specimens were retrospectively tested to "supplement the prospective study data."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states that specimens were classified into EBV serological states (Acute, EBV seronegative, Past Infection, Indeterminate) "as determined by other EBV serological reagents" and "reference EBV serology assays for EBV VCA IgG, EBV VCA IgM, and EBV EBNA-1 IgG." It does not mention the use of human "experts" or their qualifications to establish the ground truth for the test set. The ground truth was established by the results of established reference serological assays.
4. Adjudication Method for the Test Set
The document does not describe an "adjudication method" in the traditional sense involving human review of discrepancies. Instead, it details how equivocal results from both the SeraQuest test and the comparator test were handled for percent agreement calculations:
- "SeraQuest EBV EA-D IgG test equivocal results were assigned to the opposite test result interpretation than that of the corresponding comparative test results."
- "Likewise, the comparative test equivocal results were assigned to the opposite test result interpretation than that of the corresponding SeraQuest EBV EA-D IgG Test results."
This is a statistical adjustment for calculation rather than clinical adjudication by experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable to this device. The SeraQuest EBV EA-D IgG Test is an in vitro diagnostic (IVD) immunoassay, not an AI-assisted diagnostic imaging or interpretation device that would involve human "readers" or "AI assistance." The "comparator" in this study refers to another commercially available EBV EA-D IgG ELISA test, not human readers or an AI system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is applicable as the SeraQuest EBV EA-D IgG Test is an immunoassay that operates independently to produce a result. Its performance was evaluated in a standalone manner by comparing its output (positive, negative, equivocal) to the serological classification derived from reference EBV serology assays. The results presented in Tables 6 and 7 directly reflect the standalone performance of the SeraQuest test relative to the established EBV serological classification.
7. The Type of Ground Truth Used
The ground truth for classifying specimens into EBV serological states (Acute, EBV seronegative, Past Infection, Indeterminate) was established using a combination of results from reference EBV serology assays: EBV VCA IgG, EBV VCA IgM, and EBV EBNA-1 IgG. This can be categorized as serological reference assay data. The document explicitly states: "The EBV EA-D IgG result generated by the commercially available comparator EBV EA-D IgG ELISA test was not considered for purposes of characterizing the EBV serological state of the specimen."
8. The Sample Size for the Training Set
The document does not mention a "training set." This device is an immunoassay kit, not a machine learning or AI algorithm that requires a training set in the typical sense. The studies described are for clinical performance validation, not for training a model.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a "training set" in the context of this immunoassay, this question is not applicable. The "ground truth" for the performance evaluation (test set) was established using reference EBV serology assays, as described in point 7.
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ATTACHMENT 7 Quest International, Inc., 8127 NW 29th Street, Doral, FL 33122
Page No.
510(k) SUMMARY
Quest International, Inc.
8127 NW 29th Street
JUN - 8 2009
| 6727 NW 25th StreetDoral, FL 33122 | |
|---|---|
| Registration No. | 1061839 |
| Contact Person: | David J. Kiefer, Ph.D., |
| Telephone: | (305) 592-6991 |
| Telefax: | (305) 592-6834 |
| Manufacturing Site: | Same as above |
| Device: | SeraQuest® EBV EA-D IgG |
| Device Name: | Epstein-Barr virus serological reagents (21CFR § 866.3235) |
| Device Classification: | Class I (general controls) |
Description:
Applicant:
The SeraQuest EBV EA-D IgG Test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against EBV Early Antigen D (EA-D), in human serum.
Principle:
Diluted samples are incubated in wells coated with EBV Early Antigen D. Antibodies directed against the antigen (if present) are immobilized in the wells. Residual sample is eliminated by washing and draining, and conjugate (enzyme-labeled antibodies to human IgG) is added and incubated. If IgG antibodies to EBV Early Antigen D are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and draining, and the enzyme substrate is added and incubated. In the presence of the enzyme, the substrate is converted to a yellow end-product which is read photometrically at 405 nm.
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Intended Use:
The SeraQuest EBV EA-D IgG test is for the qualitative detection of human IgG antibodies to Epstein-Barr virus early antigen diffuse (EA-D) in human serum by enzyme immunoassay. This assay uses a 28 kd E. coli expressed recombinant Epstein-Barr virus early antigen. When performed in conjunction with other EBV serological tests, this assay can be used as an aid in the laboratory diagnosis of EBV infectious mononucleosis in patients with signs and symptoms of EBV infectious mononucleosis. For In Vitro Diagnostic Use Only.
Assay performance characteristics have not been established for neonatal, immunocompromised populations, cord blood, infants or pre-transplant patients. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas.
Predicate Device:
The SeraQuest® EBV EA-D IgG test is substantially equivalent in intended use and performance, to the Trinity Biotech Captia EBV EA-D IgG, Jamestown, NY.
Summary of technological characteristics:
| Characteristic | SeraQuest EBV EA-D IgG | Trinity Biotech EBV EA-D IgG |
|---|---|---|
| Description: | Enzyme Immunoassay | Enzyme Immunoassay |
| Intended Use: | The detection of IgGantibodies against EBVEA-Din human serum. | The detection of IgGantibodies against EBVEA-Din human serum. |
| Solid Phase: | Plastic Microwell | Plastic Microwell |
| Antigen : | Recombinant EA-D 28 kd | Recombinant EA-D 28 kd |
| Number of Incubation Periods: | Three | Four |
| Sample Dilution: | 1:51 | 1:21 |
| Sample IncubationDuration: | 30 minutes | 20 minutes |
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ATTACHMENT 7 Quest International, Inc., 8127 NW 29th Street, Doral, FL 33122 Page No.
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| Incubation Temperature: | Room temperature | Room temperature |
|---|---|---|
| Ezyme-labeled Conjugate: | ||
| Antibody | Goat anti-human IgG | Goat anti-human IgG |
| Label | Alkaline phosphatase | Horseradish Peroxidase |
| Conjugate Volume: | 100 µl | 100 µl |
| Conjugate IncubationDuration: | 30 minutes | 20 minutes |
| Substrate: | p-Nitrophenylphosphate | TMB |
| Subtrate Volume: | 100 µl | 100 µl |
| Substrate IncubationDuration: | 30 minutes | 10 minutes |
| Stop Reagent: | 0.5 M Trisodiumphosphate | 1M H2SO4,0.7M HCL |
| Stop Reagent Volume: | 100 µl | 50 µl |
| Readout: | Spectrophotometric | Spectrophotometric |
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Clinical Performance Comparison
Performance of the SeraQuest EBV EA-D IgG Test was evaluated against another commercially available EBV EA-D IgG ELISA test according to the EBV serological characterization of the specimens as determined by other EBV serological reagents. For purposes of classifying the EBV serological state, specimens were tested by reference EBV serology assays for EBV VCA IgG, EBV VCA IgM, and EBV EBNA-1 IgG. The EBV EA-D IgG result generated by the commercially available comparator EBV EA-D IgG ELISA test was not considered for purposes of characterizing the EBV serological state of the specimen. A total of 542 serum samples for which EBV serology tests were ordered was tested at 3 U.S. clinical testing sites. Of the 542 1 specimens, 477 were prospectively collected and prospectively tested specimens, and 65 were prospectively collected but retrospectively tested specimens to supplement the prospective study data. Of the 65 prospectively collected but retrospectively tested specimens, 50 were acute specimens and 15 were EBV seronegative specimens characterized by reference EBV serology assays for EBV VCA IgG, EBV VCA IgM, and EBV EBNA-1 IgG, Based upon the results of the three reference EBV serology tests, the specimens were categorized into one of four EBV serological state groups as indicated in Table 1 below.
| EBVserologicalstate | Specimen Group | EBVVCA IgG | EBVVCAIgM | EBVEBNA-1IgG | |
|---|---|---|---|---|---|
| Prospectively Collected andProspectively Tested | Prospectively Collected butretrospectively Tested | ||||
| Acute | 31 | 50 | + | + | - |
| - | + | - | |||
| EBVseronegative | 60 | 15 | - | - | - |
| Past Infection | 311 | 0 | + | - | + |
| Indeterminate | 75 | 0 | - | - | + |
| + | - | - |
Table 1: EBV serological state characterization
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| 3 | |||||
|---|---|---|---|---|---|
| 1 | + | t | |||
| Carolina Comments of Children+ | + | + | |||
| Total | 477 | .હક | ------------------------------------------------------------------------------ | ||
| --------. . | ALL CLAND |
- reactive; - nonreactive;
Note: When a reference assay was equivocal, it was considered nonreactive (-). The characterization by antibody response profile was not compared with clinical data regarding presence, absence or status of disease.
Using Table 1 as a guideline, testing results were analyzed by the SeraQuest EBV EA-D IgG Test and corresponding comparative EBV EA-D IgG ELISA test according to the EBV serological characterization based on EBV serology reference assays results. For the purpose of percent agreement calculations, SeraQuest EBV EA-D IgG test equivocal results were assigned to the opposite test result interpretation than that of the corresponding comparative test results. Likewise, the comparative test equivocal results were assigned to the opposite test result interpretation than that of the corresponding SeraQuest EBV EA-D IgG Test results.
Prospectively collected and prospectively tested 477 sample results from all three sites combined are summarized in Tables 2-3.
Table 2: SeraQuest EBV EA-D IgG Test vs. Comparator Assay: Comparison by EBV Serological Status Characterization
| Comparator EBV EA-D IgG Interpretation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Positive | Equivocal | Negative | ||||||||
| EBVSerologicalClassification | SeraQuest EBV EA-D | SeraQuest EBV EA-D | SeraQuest EBV EA-D | Total | ||||||
| Pos | Equ | Neg | Pos | Equ | Neg | Pos | Equ | Neg | ||
| N | N | N | N | N | N | N | N | N | N | |
| Acute | 12 | 0 | 1 | 2 | 0 | 1 | 3 | 1 | 11 | 31 |
| EBV | 4 | 2 | 1 | 0 | 1 | 5 | 2 | 4 | 41 | 60 |
| Past Infection | 65 | 13 | 11 | 7 | 8 | 12 | 17 | 14 | 164 | 311 |
| Indeterminate | 16 | 3 | 5 | 0 | 3 | 4 | 6 | 2 | 36 | 75 |
| Overall | 97 | 18 | 18 | 9 | 12 | 22 | 28 | 21 | 252 | 477 |
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Table 3: SeraQuest EBV EA-D IgG Test vs. Comparator Assay: Percent Agreement & Confidence Intervals by EBV Serological Status Characterization
| EBVSerologicalStatus | Positive Agreement | 95% CI | Negative Agreement | 95% CI | ||
|---|---|---|---|---|---|---|
| AcuteInfection | 12/14 | 85.7% | 57.2-98.2 | 11/17 | 64.7% | 38.3-85.8 |
| EBVSeronegative | 4/12 | 33.3% | 9.9-65.1 | 41/47 | 87.2% | 74.3-95.2 |
| Past infection | 65/101 | 64.4% | 55.0-73.7 | 164/202 | 81.2% | 75.8-86.6 |
| Indeterminate | 16/28 | 57.1% | 37.2-75.5 | 36/44 | 81.8% | 67.3-91.8 |
| Overall | 97/155 | 62.6% | 55.0-70.2 | 252/310 | 81.3% | 76.9-85.6 |
Prospectively collected but retrospectively tested 65 specimen results from Site A are summarized in Tables 4-5.
Table 4: SeraQuest EBV EA-D IgG Test vs. Comparator Assay: Comparison by EBV Serological Status Characterization
| Comparator EBV EA-D IgG Interpretation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| EBVSerologicalClassification | Positive | Equivocal | Negative | Total | ||||||
| SeraQuest EBV EA-D | SeraQuest EBV EA-D | SeraQuest EBV EA-D | ||||||||
| Pos | Equ | Neg | Pos | Equ | Neg | Pos | Equ | Neg | ||
| N | N | N | N | N | N | N | N | N | N | |
| Acute | 32 | 0 | 0 | 1 | 1 | 1 | 2 | 3 | 10 | 50 |
| EBV | 0 | 0 | 3 | 0 | 0 | 1 | 1 | 1 | 9 | 15 |
| Overall | 32 | 0 | 3 | 1 | 1 | 2 | 3 | 4 | 19 | 65 |
Table 5: SeraQuest EBV EA-D IgG Test vs. Comparator Assay: Percent Agreement & Confidence Intervals by EBV Serological Status Characterization
| EBVSerologicalStatus | Positive Agreement | 95% CI | Negative Agreement | 95% CI | ||
|---|---|---|---|---|---|---|
| AcuteInfection | 32/33 | 97.0% | 84.2-99.9 | 10/16 | 62.5% | 35.4 - 84.8 |
| EBVSeronegative | 0/4 | 0% | 0 - 60.2 | 9/11 | 81.8% | 48.2 - 97.7 |
| Overall | 32/37 | 86.5% | 71.2-95.5 | 19/27 | 70.4% | 49.8 - 86.2 |
In addition, test results generated by both the SeraQuest EBV EA-D IgG Test and the comparator EA-D IgG Assay relative to the actual EBV serological characterization of either acute intection, EBV seronegative or past infection, as determined by the
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reference EBV serology assays for EBV VCA IgG, EBV VCA IgM, and EBV EBNA-1 IgG, for the 477 prospectively collected and tested specimens and the 65 prospectively collected but retrospectively tested specimens, are presented in Tables 6-7.
Table 6: Agreement of the Comparator EBV EA-D IgG Test, and the SeraQuest EBV EA-D IgG Test, relative to the EBV Serological Classification, for the prospectively collected and tested specimens
| Prospectively Collected and Tested | ||||
|---|---|---|---|---|
| ComparatorEBV EA-DIgG Test | 95% CI | SeraQuestEBV EA-DIgG Test | 95% CI | |
| PositiveAgreement(AcuteInfection) | 13/3141.9% | 24.5-60.9 | 17/31 54.8% | 36.0-72.7 |
| NegativeAgreement(EBVSeronegative) | 47/6078.3% | 65.8-87.9 | 47/60 78.3% | 65.8-87.9 |
| NegativeAgreement(Past Infection) | 195/31162.7% | 57.3-68.1 | 187/31160.1% | 54.7-65.6 |
Table 7: Agreements of the Comparator EBV EA-D IgG Test, and the SeraQuest EBV EA-D IgG Test, relative to the EBV Serological Classification, for the prospectively collected and retrospectively tested specimens
| Prospectively Collected and Retrospectively Tested | ||||
|---|---|---|---|---|
| ComparatorEBV EA-DIgG Test | 95% CI | SeraQuestEBV EA-DIgG Test | 95% CI | |
| PositiveAgreement(AcuteInfection) | 32/5064.0% | 49.2-77.1 | 35/50 70.0% | 55.4-82.1 |
| NegativeAgreement(No Infection) | 11/1573.3% | 44.9-92.2 | 13/15 86.7% | 59.5-98.3 |
Cross-reactivity
The cross-reactivity study was designed to determine if samples from various disease states and other potentially interfering factors interfere with test results when tested with the SeraQuest EBV EA-D IgG Test. Specimens that were positive for various infectious diseases, heterophilic antibodies, autoimmune antibodies and antibodies against other EBV markers were tested with the SeraQuest EBV EA-D IgG Test. Samples for these
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ATTACHMENT 7 Quest International, Inc., 8127 NW 29th Street, Doral, FL 33122
studies were selected using commercially available devices. Results can be found in Table 8.
Table 8: Cross-Reactivity
| Analytes/Condition | Number of samples | Positive orEquivocalSeraQuest EBVEA-D IgG TestResult |
|---|---|---|
| CytomegalovirusIgG | 7 | 0/7 |
| Herpes simplexvirus 1&2 IgG | 7 | 0/7 |
| Varicella zostervirus IgG | 11 | 0/11 |
| Anti-NuclearAntigen antibodies | 2 | 0/2 |
| Cytoplasmaticantigen SS-Aantibodies | 4 | 0/4 |
| Cytoplasmaticantigen SS-Bantibodies | 4 | 0/4 |
| Extractable nuclearantigen Smantibodies | 4 | 0/4 |
| Cardiolipin IgG | 6 | 0/6 |
| Rheumatoid Factor | 2 | 0/2 |
| EBV VCA IgG | 152 | 0/152 |
| EBV VCA IgM | 2 | 0/2 |
| EBV-NA antibodies | 115 | 0/115 |
| Total | 316 | 0/316 |
None of the 316 total specimens tested in the cross-reactivity studies returned positive or equivocal results in the SeraQuest EBV EA-D IgG Test.
Warning: Potential cross-reactivity of the SeraQuest EBV EA-D IgG Test with IgG antibodies to Toxoplasma gondii, Rubella virus, HIV, HAV, HBV, and HCV was not tested and determined. The user is responsible for establishing cross-reactivity performance with these infectious agents.
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Potential Interfering Substances
The possible effects of icterus, hemolysis, hyperglycemia, hyperlipidemia and hyperproteinemia, on the results of the SeraQuest EBV EA-D IgG test, were examined. A sample panel consisted of one weak positive serum sample (close to the assay cut-off) and one negative sample was prepared. Each serum specimen was first tested without any of the additive. This served as the control representing the normal physiological concentration of each of the potential interfering substances. In addition, aliquots of each serum specimen were supplemented with 8 times the normal level of each potential interferent. These levels were selected to exceed the levels that could be present in disease state sera. The normal and the "enriched" serum specimens with bilirubin, hemoclobin, glucose, cholesterol, and gamma globulin were tested following the SeraQuest EBV EA-D IgG Instructions for Use. Results can be found in Table 9.
| ANALYTE CONCENTRATION | ||||
|---|---|---|---|---|
| NORMAL | ELEVATED | |||
| ANALYTE | POS (+) SAMPLE INDEX | NEG (-) SAMPLE INDEX | POS (+) SAMPLE INDEX | NEG (-) SAMPLE INDEX |
| BILIRUBIN | 1.5 | 0.4 | 1.5 | 0.3 |
| HEMOGLOBIN | 1.4 | 0.4 | 1.3 | 0.4 |
| GLUCOSE | 1.5 | 0.4 | 1.5 | 0.4 |
| CHOLESTEROL | 1.4 | 0.4 | 1.4 | 0.6 |
| GLOBULIN | 1.8 | 0.4 | 2.3 | 0.4 |
Table 9: SeraQuest EBV EA-D IgG Test Results with Potential Interfering Substances
No significant interference was observed in the presence of up to eight times the normal physiological concentration of each of the potential interfering substances tested with the SeraQuest EBV EA-D IgG Test. There were no false negative results for the weak positive specimen and no false positive results for the negative specimens that were encountered in the presence of each of the potential interfering substances.
Warning: While the limited amount of data presented in the study above may not demonstrate it, serum specimens with elevated levels of these interfering substances may generate erroneous results. Grossly hemolyzed, icteric or lipemic samples as well as samples containing particulate matter or exhibiting obvious microbial contamination are not recommended and should not be tested
Precision
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A reproducibility panel of 6 members was prepared by the Quest International laboratory. One (1) of the six panel members was negative for EBV EA-D IgG. One (1) of the 6 panel members had levels of EBV EA-D IgG near the assay cut-off that was considered a high negative to equivocal sample. Four (4) of the six panel members were positive for EBV EA-D IgG. All panel members were prepared from patient samples. This panel was split into aliquots and tested at 3 different clinical sites. In addition, 1 SeraQuest human Anti-EA-D IgG positive serum control and 1 SeraQuest human Anti-EA-D IgG negative serum control were also tested. Each of the 6 panel members and the SeraQuest positive and negative controls were tested three times (x3) on each day in one run for 3 days at each of the 3 US testing sites (3 times x 3 days x 3 sites = 27 replicates per panel member and SeraQuest control). The data was analyzed for intra-assay, inter-assay and between-site reproducibility. The standard deviation (SD) and percent coefficient of variation (%CV) were also calculated. Results can be found in Table 10.
| Name ofanalytePanelMembers | SampleN | MeanIndex | Intra-Assay | Inter-Assay | Between-Site | Total | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | |||
| SeraQuestPositiveSerumControl | 27 | 1.7 | 0.05 | 3.1 | 0.13 | 8.0 | 0.32 | 19.3 | 0.14 | 8.0 |
| SeraQuestNegativeSerumControl | 27 | 0.4 | 0.01 | 4.1 | 0.04 | 9.1 | 0.07 | 21.0 | 0.03 | 8.4 |
| Highnegativetoequivocal(NearC.O.) | 27 | 0.7 | 0.04 | 5.7 | 0.07 | 9.5 | 0.10 | 14.2 | 0.03 | 4.2 |
| Negative | 27 | 0.2 | 0.05 | 18.2 | 0.06 | 23.1 | 0.12 | 46.7 | 0.04 | 14.0 |
| Positive 1 | 27 | 1.7 | 0.08 | 4.2 | 0.09 | 5.8 | 0.40 | 23.8 | 0.19 | 10.5 |
| Positive 2 | 27 | 1.3 | 0.07 | 5.2 | 0.07 | 5.9 | 0.26 | 19.5 | 0.11 | 7.9 |
| Positive 3 | 27 | 1.3 | 0.04 | 3.0 | 0.08 | 6.6 | 0.26 | 20.5 | 0.12 | 8.9 |
| Positive 4 | 27 | 1.7 | 0.09 | 4.7 | 0.24 | 14.1 | 0.40 | 24.1 | 0.16 | 9.2 |
Table 10: Reproducibility (Values were calculated from the SeraQuest index values.)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. David Kiefer President Quest International, Inc. 8127 N. W. 29th Street Doral, FL 33122
JUN ~ 8 2009
Re: K091260
Trade/Device Name: SeraQuest EBV EA-D IgG Test Regulation Number: 21 CFR 866.3235 Regulation Name: Multiple antibodies immunological test system Regulatory Class: Class I Product Code: LSE Dated: April 3, 2009 Received: April 29, 2009
Dear Dr. Kiefer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations , affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attaym
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number: K091260
Device Name: SeraQuest EBV EA-D IgG
Indication For Use:
The SeraQuest EBV EA-D IgG test is for the qualitative detection of human IgG antibodies to Epstein-Barr virus early antigen diffuse (EA-D) in human serum by enzyme immunoassay. This assay uses a 28 kd E. coli expressed recombinant Epstein-Barr virus early antigen. When performed in conjunction with other EBV serological tests, this assay can be used as an aid in the laboratory diagnosis of EBV infectious monomucleosis in patients with signs and symptoms of EBV infectious mononucleosis. For In Vitro Diagnostic Use Only.
Assay performance characteristics have not been established for neonatal, immunocompromised populations, cord blood, infants or pre-transplant patients. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas.
Prescription Use X And/Or (21 CFR Part 801 Subpart D)
Over the Counter Use 11.000 (21 CFR Part 801 Subpart C)
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Uwe Schef
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091260
§ 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).