(286 days)
For the qualitative and semi-quantitative determination of IgG antibodies to Epstein-Barr Virus (recombinant) Viral Capsid Antigen (EBV-VCA IgG) in human serum by indirect enzyme immunoassay. The Is-EBV-VCA IgG Test Kit may be used in combination with other Epstein-Barr serologies (Viral Capsid Antigen (VCA) IgM , Epstein-Barr Nuclear Antigen-1 (EBNA-1) IgG and IgM, Early Antigen-Diffuse (EA-D) IgG and IgM and heterophile antibody as an aid in the diagnosis of infectious mononucleosis (IM). The evaluation of paired sera, to determine a significant increase in VCA 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 EBV-VCA IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to Epstein Barr viral capsid antigen in human serum. Recombinant VCA antigen is bound to microwells. Diluted patient sera, Cut-Off Calibrator and controls are placed in the microwells and incubated. Anti-VCA IgG antibodes, if present, will bind to the antigen forming, antigen-antibody complexes. Residual sample is eliminated by aspirating and washing. Conjugate (horseradish peroxidase-labeled anti-human IgG) is added and will bind to these complexes. Unbound conjugate is removed by aspiration and washing. Substrate is then added and incubated. In the presence of bound enzyme the substrate is converted to an end product. The absorbance of this end product can be read spectrophotometrically at 450 nm (reference 600-630 nm) and is directly proportional to the concentration of IgG antibodies to VCA present in the sample.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined set of thresholds that the device must meet. Instead, it presents the "Performance Characteristics" of the proposed device and implicitly compares them to the predicate device. For this table, I will infer "acceptance criteria" from the performance characteristics of the predicate device (Wampole EBV-VCA IgG ELISA) and the general expectation for such tests, and then show the proposed device's performance against them.
| Performance Metric | Acceptance Criteria (Inferred from Predicate/Industry Standard) | Reported Device Performance (Diamedix Is-EBV-VCA IgG ELISA Kit) |
|---|---|---|
| Relative Sensitivity | Likely 100% (as per predicate) | 100% (for past infection sera) |
| Relative Sensitivity (Current Infection) | Not explicitly stated for predicate, but high sensitivity expected | 84.8% |
| Relative Specificity (Seronegative) | 100% (as per predicate) | 93.8% |
| Overall Agreement | 100% (as per predicate) | 95.7% |
| Intra-assay Precision (CV%) | Below 10.0% for positive samples (typical for ELISA) | Manual: 1.56-9.30% MAGO Plus: 2.48-12.03% |
| Inter-assay Precision (CV%) | Below 15.0% for positive samples (typical for ELISA) | Manual: 4.28-10.50% MAGO Plus: 6.99-9.21% |
| Cross-reactivity | No significant cross-reactivity expected | No cross-reactivity with VZV, CMV, HSV IgG antibodies |
| Manual/Automated Correlation (Pearson Correlation Coefficient) | Strong positive correlation (e.g., >0.90) expected | 0.986 |
Notes on Acceptance Criteria:
- The document frames the study as demonstrating "substantial equivalence" to the predicate device, the Wampole VCA IgG ELISA. Therefore, the predicate device's performance characteristics serve as the primary benchmark.
- "Relative Sensitivity" is given for "Current Infection" specifically for the proposed device, while the predicate only lists "Relative Sensitivity" generally. This indicates a more nuanced evaluation of the proposed device.
- Precision results from Site #2 for MAGO Plus show one value (12.03%) for a positive sample (Serum C, Run 3) that is slightly higher than a typical 10% threshold, but overall the ranges are within acceptable limits for diagnostic assays. The negative sample precision can be higher.
2. Sample size used for the test set and the data provenance:
- Sample Size: 175 frozen retrospective sera.
- 102 convalescent sera
- 34 seronegative sera
- 39 current (recent) infection sera
- Data Provenance: The document states "Frozen retrospective sera from one hundred and seventy-five patients were characterized using commercially available kits..." It does not specify the country of origin of the data. It explicitly states the data is retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The ground truth for the test set was established using commercially available kits for VCA IgG, VCA IgM, EBNA IgG and heterophile antibodies, rather than human expert consensus. Therefore, no information is provided on the number or qualifications of experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. The ground truth was established by laboratory testing with commercially available kits, not through human adjudication of interpretations.
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:
No, a multi-reader multi-case comparative effectiveness study was not performed. This device is an ELISA kit, which is a laboratory test for determining antibody presence, not an imaging or diagnostic AI tool that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance study was done. The "Clinical Sensitivity and Specificity Using Characterized Sera" section directly assesses the performance of the Is-EBV-VCA IgG Test Kit (the algorithm/device) against the established serological status of patient samples. The device yielded quantitative results (index values) that were interpreted as positive, negative, or equivocal based on predetermined cut-offs.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth was established by serological characterization using commercially available diagnostic kits. Specifically, sera were categorized as convalescent, seronegative, or current infection based on their reactivity patterns to VCA IgG, VCA IgM, EBNA IgG, and heterophile antibodies using reference kits. This is a form of reference standard testing (laboratory test results).
8. The sample size for the training set:
The document does not mention a training set. This type of device (ELISA kit) typically does not involve machine learning or AI models that require a separate training set. Its manufacturing and calibration are based on established biochemical principles and quality control, not iterative learning from data.
9. How the ground truth for the training set was established:
Not applicable, as no training set is mentioned or implied for this type of diagnostic kit.
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3/4/99
K98/812
510k Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the quirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K981812
Applicant Information
| 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 |
්යා
Device Information:
| Trade Name: | EBV VCA IgG ELISA Kit |
|---|---|
| Common Name: | EBV Viral Capsid Antigen FIA Test |
| Classification Name: | Epstein Barr Virus Serological Reagent |
Equivalent Device Description:
Wampole VCA IgG ELISA
Wampole VCA IgG ELISA kit contains instructions and materials for the qualitative and semi-quantitative tection of IgG antibodies to EBV-VCA IgG in human serum by indirect ELISA
The EBV-VCA IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to Epstein Barr viral capsid antigen in human serum.
Intended Use: For the qualitative and semi-quantitative determination of IgG antibodies to Epstein-Barr Virus (recombinant) Viral Capsid Antigen (EBV-VCA IgG) in human serum by indirect enzyme immunoassay. The Is-EBV-VCA IgG Test Kit may be used in combination with other Epstein-Barr serologies (Viral Capsid Antigen (VCA) IgM , Epstein-Barr Nuclear Antigen-1 (EBNA-1) IgG and IgM, Early Antigen-Diffuse (EA-D) IgG and IgM and heterophile antibody as an aid in the diagnosis of infectious mononucleosis (IM). The evaluation of pared sera, to determine a significant increase in VCA 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.
Principle of Procedure:
Recombinant VCA antigen is bound to microwells. Diluted patient sera. Cut-Off Calibrator and controls are placed in the microwells and incubated. Anti-VCA IgG antibodes, if present, will bind to the antigen forming, antigen-antibody complexes. Residual sample is eliminated by aspirating and washing. Conjugate (horseradish peroxidase-labeled anti-human IgG) is added and will bind to these complexes. Unbound conjugate is removed by aspiration and washing. Substrate is then added and incubated. In the presence of bound enzyme the substrate is converted to an end product. The absorbance of this end product can be read spectrophotometrically at 450
{1}------------------------------------------------
nm (reference 600-630 nm) and is directly proportional to the concentration of IgG antibodies to VCA present m the sample
ie Is-EBV-VCA IgG ELISA kit and the Wampole VCA IgG ELISA are substantially equivalent in that.
- Both are in vitro immunologic methods. 1.
- 2 Both are intended for use in the detection of IgG antibody to EBV-VCA in human serum
- 3 Both are based on the formation of a complex between VCA antigens and antibody
- 4 Both use antigen coated microtiter plates.
-
- Both are qualitative/semi-quantitative assays.
- రు. Both use goat anti-human IgG conjugated to horseradish peroxidase.
-
- Both use TMB as the enzyme substrate
A detailed comparison between the proposed devise and the predicate device is shown in Table 1
Conclusions: The Diamedix Is-EBV-VCA IgG is substantially equivalent to the Wampole VCA ELISA for the detection of IgG antibodies to EBV-VCA 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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1883678
PREDICATE DEVICE
POOls FRV-VC A løG FI ...
| Table 1 | ||
|---|---|---|
| PROPOSED DEVICEDiamedix Is-EBV-VCA IgG ELISA Kit | PREDICATE DEVICEWampole EBV-VCA IgG ELISA | |
| Ended Use | For the qualitative and semi-quantitative determination ofIgG antibodies to Epstein-Barr Virus Viral CapsidAntigen (EBV-VCA IgG) in human serum by indirectenzyme immunoassay. The Is-EBV-VCA IgG Test Kitmay be used in combination with other Epstein-Barrserologies (Viral Capsid Antigen (VCA) IgM, Epstein-Barr Nuclear Antigen-1 (EBNA-1) IgM, Early Antigen-Diffuse (EA-D) IgG and IgM and heterophile antibody asan aid in the diagnosis of infectious mononucleosis (IM).The evaluation of paired sera, to determine a significantincrease in VCA IgG antibody titer, can also aid in thediagnosis of acute infection. These reagents can be usedeither manually or in conjunction with the MAGO® PlusAutomated Processor. | The Wampole Laboratories (Wampole) Epstein-BarrVirus-Viral Capsid IgG Enzyme-Linked ImmunoSorbentAssay (ELISA) is intended for the qualitative and semi-quantitative determination of IgG antibody in humanserum to Epstein-Barr virus in human sera. A singleserum specimen may be used to indicate previousinfection or immune status with the Epstein-Barr virusPaired sera, acute and convalescent, may be used todemonstrate seroconversion or a significant rise inantibody level as an aid in the diagnosis of a recent orcurrent infection, or reactivation; and as an aid in thediagnosis of Infections Mononucleosis (IM). |
| Methodology | Enzyme immunoassay (EIA) | Enzyme Linked Immunosorbent Assay (ELISA) |
| Specifications | For in vitro diagnostic use.For use with fresh or frozen human serum.Avoid lipemic, hemolyzed, contaminated, or icteric sera.Assay performed on 1:21 dilution of serum at 18-30°C.Store at 2-8°C. | For in vitro diagnostic use. For use with fresh or frozenhuman serum. Assay performed on 1:21 dilution ofserum at 21-25°C. Store at 2-8°C. |
| Design | Is-EBV-VCA IgG Test Kit. 96 determinations. Un-diluted Calibrator, Positive, and Negative controls. | VCA IgG ELISA. 96 determinations. UndilutedCalibrator, High positive, Low positive, and Negativecontrols. |
| Principles ofOperation | Purified, recombinant VCA antigen is bound tomicrowells (solid phase). Diluted human serum is addedto the microwell which binds human anti-VCA IgG, ifpresent. Solid phase is washed and exposed to anti-human IgG conjugate. Solid phase is washed andexposed to enzyme substrate to develop color. Strongacid is added to stop reaction. The color is read at450/600 nm on an EIA reader. | Diluted patient serum is incubated with purified, VCAantigen bound to the solid surface of a microtiter well. IfIgG antibodies against EBV-VCA are present in theserum, antigen-antibody complexes are formed. Thesecomplexes bind with HRP-labeled anti-human IgG whichreact with the addition of chromogen, resulting in a colordevelopment. The absorbance is measured at 450/630nm. |
| PerformanceCharacteristics | Relative Sensitivity: 100%Relative Sensitivity (Current Infection): 84.8% RelativeSpecificity (Seronegative): 93.8%Agreement: 95.7%Intra-assay Precision (Positive samples, all sites)Overall Manual- 1.56-9.30 MAGO Plus- 2.48-12.03Interassay Precision (Positive samples, all sites)Overall Manual- 4.28-10.50 MAGO Plus- 6.99-9.21No Cross-reactivity | Relative Sensitivity: 100%Relative Specificity: 100%Agreement: 100%Inter-Site Precision (Positive samples, all sites)Overall: 1.9-9.6%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 | <0.90 Negative for VCA IgG0.90-1.09 Equivocal for VCA IgG> 1.10 Positive for VCA IgG | <0.90 Negative for VCA IgG0.91-1.09 Equivocal for VCA IgG> 1.10 Positive for VCA 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 |
Table 1
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Performance Characteristics
Is-IEBV-VCA I
A. Clinical Sensitivity and Specificity Using Characterized Sera
Frozen retrospective sera from one hundred and seventy-five patients were characterized using commercially available kits for VCA IgG, VCA IgM, EBNA IgG and heterophile antibodies, Based on the results of this testing, the patient sera were characterized as follows :
- · 102 sera were characterized as convalescent (past infection). These were positive for VCA IgG and or EBNA IgG antibodies and negative for VCA IgM and heterophile antibody.
- · 34 sera were characterized as seronegative. These were negative for VCA IgG. VCA IgM, EBNA IgG and heterophile antibody.
- · 39 sera were characterized as having a current (recent) intection. These were positive for VCA IgM and/or heterophile antibody and were negative for EBNA IgG.
All 175 sera were then tested by an independent clinical commercial laboratory using the Is-I:IBV-VCA IgG Test Kit. The results obtained are shown in Table 2:
| TABLE 2 | Convalescent | Current Infection | Seronegative | |
|---|---|---|---|---|
| IgG | POSITIVE | 99 | 28 | 2 |
| NEGATIVE | 0 | 5 | 30 | |
| EQUIVOCAL | 3 | 6 | 2 |
EBV Serological Status
- · Of the 102 past infection sera tested, 99 were positive for anti-VCA 1gG, none were negative, and 3 were equivocal.
- · Of the thirty-seven current (recent) infection samples lested, twenty-eight were positive, five were negative, and 6 were equivocal
- · Of the thirty-four seronegative sera tested, thirty were negative, two were possitive, and two were equivocal.
- · The overall agreement of the Is-VCA IgG Test Kit compared to EBV serological status was 157/164 = 95.7%:
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B. Precision
To determine the precision of the Is-FINV-VCA IgG Test Kit, four positive and two negative sera were assayed ten times each in three different runs at three different sites included: the manufacturer, a research & development laboratory, and a clinical commercial laboratory. The intrassay precision obtained at each site is shown in Tables 3, 4 and 5.
| SERUM | INTRA-ASSAY RUN 1 | INTRA-ASSAY RUN 2 | INTRA-ASSAY RUN 3 | INTERASSAY | ||||
|---|---|---|---|---|---|---|---|---|
| MEANINDEX | CV% | MEANINDEX | CV% | MEANINDEX | CV% | MEANINDEX | CV% | |
| A (POS) | 1.74 | 3.19 | 1.98 | 6.84 | 1.64 | 7.16 | 1.79 | 10.13 |
| B (POS) | 2.05 | 5.34 | 2.42 | 4.11 | 1.98 | 6.56 | 2.15 | 10.50 |
| C (POS) | 1.42 | 4.56 | 1.55 | 9.30 | 1.48 | 9.05 | 1.48 | 8.63 |
| D (POS) | 3.12 | 4.38 | 3.31 | 4.49 | 3.07 | 4.17 | 3.17 | 5.40 |
| E (NEG) | 0.54 | 16.22 | 0.58 | 11.87 | 0.54 | 11.17 | 0.55 | 13.30 |
| F (NEG) | 0.21 | 16.31 | 0.25 | 21.86 | 0.21 | 12.12 | 0.22 | 19.06 |
| CAL | 1.04 | 13.48 | ||||||
| PC | 1.75 | 15.91 | ||||||
| NC | 0.12 | 0.00 |
TABLE 3 : Site #1 - Intra-Assay and Interassay Precision
| TABLE 4 : Site #2- 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) | 1.59 | 4.45 | 1.52 | 3.20 | 1.67 | 3.23 | 1.60 | 5.31 |
| B (POS) | 1.96 | 3.41 | 1.87 | 2.14 | 2.04 | 3.45 | 1.96 | 4.71 |
| C (POS) | 1.54 | 3.86 | 1.33 | 3.43 | 1.52 | 1.56 | 1.46 | 7.10 |
| D (POS) | 3.27 | 2.40 | 2.90 | 1.86 | 3.23 | 2.74 | 3.13 | 5.91 |
| E (NEG) | 0.55 | 5.11 | 0.55 | 2.29 | 0.64 | 3.76 | 0.58 | 8.22 |
| F (NEG) | 0.231 | 3.36 | 0.25 | 4.86 | 0.28 | 9.96 | 0.25 | 10.66 |
| CAL | 1.00 | 1.80 | ||||||
| PC | 1.47 | 4.24 | ||||||
| NC | 0.16 | 6.13 |
TABLE 5 : Site #3 - Intra-assay and Interassay Precision
| SERUM | INTRA-ASSAY RUN 1 | INTRA-ASSAY RUN 2 | INTRA-ASSAY RUN 3 | INTERASSAY | ||||
|---|---|---|---|---|---|---|---|---|
| MEAN | CV% | MEAN | CV% | MEAN | CV% | MEAN | CV% | |
| INDEX | INDEX | INDEX | INDEX | |||||
| A (POS) | 1.59 | 3.51 | 1.56 | 5.21 | 1.52 | 3.00 | 1.55 | 4.37 |
| B (POS) | 1.91 | 4.17 | 1.89 | 4.58 | 1.85 | 6.07 | 1.88 | 5.04 |
| C (POS) | 1.44 | 4.60 | 1.36 | 3.53 | 1.37 | 3.26 | 1.39 | 4.61 |
| D (POS) | 3.05 | 4.38 | 3.02 | 3.43 | 2.91 | 3.88 | 2.99 | 4.28 |
| E (NEG) | 0.55 | 6.77 | 0.60 | 7.37 | 0.54 | 5.08 | 0.56 | 8.25 |
| F (NEG) | 0.28 | 8.78 | 0.36 | 64.52 | 0.27 | 15.22 | 0.30 | 46.46 |
| CAL | 1.00 | 3.87 | ||||||
| PC | 1.33 | 16.45 | ||||||
| NC | 0.20 | 28.00 |
C. Specificity with Potentially Cross-Reactive Sera
Sixtcen sera, non-reactive (negative) for IeG antibodies to VCA in the Is-EBV-VCA IgG Test Kit, were ested by HA for IgG antibody to varicella zoster, cylomegalovirus and herpes simplex virus. 15/15 anti-VZV IgG positive sera were non-reactive for anti-YCA IgG; 3/3 mi-CMV IgG possible sera were non-reactive for anti-VCA IgG and 3/3 anti-HSV positive sera were non-reactive for anti-VCA IgG. This suggests that no specific cross-reactivity should by expected with the Is-EBV-VCA IgG Test Kit from these analytes.
D. Correlation of Manual and MAGO Plus Results
The Is-FINV-VCA 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 196 serum samples tested by both methods were plotted. A scattergram and regression line of the results obtained with 95% confidence intervals is shown in Figure 3 The data indicate good correlation with a Pearson Correlation Cocfficient of 0.986.
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JUN
Image /page/5/Figure/3 description: This image is a scatter plot that shows the relationship between manual index values and MAGO plus index values. The x-axis represents the manual index values, and the y-axis represents the MAGO plus index values. The plot includes a regression line with the equation Y = -0.1151 + 1.2556X, and the correlation coefficient (r) is 0.9860, indicating a strong positive correlation between the two variables.
FIGURE 3 : Manual and MAGO Plus Result Correlation
D. MAGO Plus Precision
The precision of the assay when performed on the MAGO Plus Automated E1A Processor was determined by assaying six sera ten times cach in three different runs. Table 6 shows the intra-and interassay precision obtained using the MAGO Plus.
| TABLE 6 : Site #2- Intra-Assay and Interassay Precision - 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) | 1.68 | 3.76 | 1.52 | 4.16 | 1.67 | 7.50 | 1.62 | 6.99 |
| B (POS) | 2.15 | 5.48 | 1.89 | 4.63 | 2.07 | 4.58 | 2.04 | 7.23 |
| C (POS) | 1.63 | 2.96 | 1.44 | 5.86 | 1.49 | 12.03 | 1.52 | 9.21 |
| D (POS) | 3.57 | 3.75 | 3.06 | 3.51 | 3.18 | 2.48 | 3.27 | 7.50 |
| E (NEG) | 0.60 | 0.00 | 0.52 | 8.11 | 0.51 | 11.13 | 0.54 | 10.46 |
| F (NEG) | 0.30 | 15.71 | 0.25 | 21.08 | 0.21 | 15.06 | 0.25 | 22.55 |
| CAL | 1.00 | 5.54 | ||||||
| PC | 1.43 | 4.03 | ||||||
| NC | 0.20 | 0.00 |
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized image of an eagle or bird-like figure with three overlapping wing-like shapes.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR - 4 1999
Diamedix Corp. c/o Norman Jenkins President Columbia Bioscience, Inc. 8775 M Centre Park Drive, #559 Columbia, MD 21045
Re: K981812
Trade Name: EBV-VCA IgG ELISA Test System Regulatory Class: I Product Code: LSE Dated: December 8, 1998 Received: December 9, 1998
Dear Mr. Jenkins:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{8}------------------------------------------------
510(k) Number: K981812
Device Name: EBV- VCA IgG ELISA
Indications For Use: For the qualitative and semi-quantitative determination of IgG antibodies to Epstein-Barr Virus (recombinant) Viral Capsid Antigen (EBV-VCA IgG) in human serum by indirect enzyme immunoassay. The Is-EBV-VCA IgG Test Kit may be used in combination with other Epstein-Barr serologies (Viral Capsid Antigen (VCA) IgM , Epstein-Barr Nuclear Antigen-1 (EBNA-1) IgG and IgM, Early Antigen-Diffuse (EA-D) IgG and IgM and heterophile antibody as an aid in the diagnosis of infectious mononucleosis (IM). The evaluation of paired sera, to determine a significant increase in VCA 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 (Per 21 CFR 801.109)
OR
Over-The Counter Use (Optional Format 1-2-96)
Woodley Dubois
() Number
§ 866.3235 Epstein-Barr virus serological reagents.
(a)
Identification. Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).(b)
Classification. Class I (general controls).