(142 days)
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No
The summary describes a standard ELISA kit and an automated processor, neither of which are indicated to use AI/ML. There is no mention of AI, ML, or related terms, nor is there a description of a training or test set for an AI/ML model.
No.
This device is an in vitro diagnostic assay used to detect antibodies for diagnostic purposes, not to treat or prevent a disease.
Yes
The intended use explicitly states, "The 78 EBNA-1 IgM assay should be used in conjunction with other Epstein-Barr serologies (VCA IgM, VCA IgG, EA-D IgG, EBNA-1 IgG and heterophile) as an aid in the diagnosis of infectious mononucleosis." This clearly indicates its role in aiding diagnosis.
No
The device is an ELISA kit, which is a laboratory assay involving physical reagents and processes, not solely software. While it can be used with an automated processor (which likely involves software), the core device itself is a hardware-based diagnostic kit.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the qualitative determination of IgM antibodies in human serum to Epsien Barr Virus (recombinant) Nuclear antigen (EBNA-1) antigen." This indicates the device is used to test a sample taken from the human body (serum) in vitro (outside the body) to provide diagnostic information.
- Device Description: The description confirms it's an "enzyme-linked immunosorbent assay (ELISA) for the detection of IgM antibodies to Epstein-Barr Nuclear antigen-1 in human serum." This further reinforces its use for in vitro testing of a human sample.
- Aid in Diagnosis: The intended use also states it should be used "as an aid in the diagnosis of infectious mononucleosis." This clearly links the test results to providing information for a medical diagnosis.
These points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
For the qualitative determination of IgM antibodies in human serum to Epsien Barr Virus (recombinant) Nuclear antigen (EBNA-1) antigen. The 78 EBNA-1 IgM assay should be used in conjunction with other Epstein-Barr serologies (VCA IgM, VCA IgG, EA-D IgG, EBNA-1 IgG and heterophile) as an aid in the diagnosis of infectious mononucleosis. The test can be performed either manually or in conjunction with the MAGO PLUS TM Automated EIA Processor.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The & EBNA-1 IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgM antibodies to Epstein-Barr Nuclear antigen-1 in human serum.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human serum
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A. Clinical Sensitivity and Specificity Using Characterized Sera
Frozen retrospective sera from one hundred and seventy-six patients were characterized using commercially available kits for VCA IgM, VCA IgG, EBNA-1 IgG and heterophile antibodies. Results presented in Table 2.
Relative Specificity (Convalescent) was 97.0% (95% CI: 91.6-99.4) for 98/101 samples.
Relative Sensitivity (Current Infection) was 59.5% (95% CI: 42.1-75.3) for 22/37 samples.
Relative Specificity (Seronegative) was 100.0% (95% CI: 89.1-100.0) for 32/32 samples.
Overall Agreement was 89.4% (95% CI: 84.8-94.0) for 152/170 samples.
B. Precision
Three positive sera were assayed ten times each in three different runs at three different sites (manufacturer, research and development laboratory, and clinical commercial laboratory). Intra- and interassay precision results are shown in Tables 3, 4, 5, and 6.
C. Specificity with Potentially Cross-Reactive Sera
Thirteen sera, reactive for IgM antibodies to varicella zoster, cytomegalovirus and herpes simplex virus by EIA were tested.
4/4 anti-VZV IgM positive sera were non-reactive for anti-EBNA-1 IgM.
2/5 anti-CMV IgM positive sera were non-reactive for anti-EBNA-1 IgM.
4/4 anti-HSV positive sera were non-reactive for anti-EBNA IgM.
This suggests some specific cross-reactivity should be expected with the Is-EBNA-I IgM Test Kit from these analytes.
D. Correlation of Manual and MAGO Plus Results
129 serum samples were tested manually and with the MAGO Plus. A scattergram and regression line showed good correlation with a Pearson Correlation Coefficient of 0.985.
E. MAGO Plus Precision
The precision of the assay on the MAGO Plus was determined by assaying six sera ten times each in three different runs. Table 7 shows intra- and interassay precision for MAGO Plus.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Specificity (Convalescent) = 97.0% (95% CI: 91.6-99.4)
Relative Sensitivity (Current Infection) = 59.5% (95% CI: 42.1-75.3)
Relative Specificity (Seronegative) = 100.0% (95% CI: 89.1-100.0)
Overall Agreement = 89.4% (95% CI: 84.8-94.0)
Pearson Correlation Coefficient = 0.985
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.
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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.
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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).
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§ 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
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:
Applicant Information:
| Date Prepared: | March 23, 1998 |
|---|---|
| Name: | Columbia Bioscience, Inc. |
| Address: | 8775 M Centre Park Drive, #559 |
| Columbia, MD 21045 |
| Contact Person: | Norman Jenkins |
|---|---|
| PhoneNumber. | 410-995-0450 |
| Fax Number. | 410-995-0448 |
Device Information:
| Trade Name: | EBNA-1 IgM ELISA Kit |
|---|---|
| Common Name. | EBNA-1 IgM EIA Test |
| Classification Name; | Epstein-Barr Virus |
Equivalent Device: EBV Serology
Device Description: The & EBNA-1 IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgM antibodies to Epstein-Barr Nuclear antigen-1 in human serum.
Intended Use: For the qualitative determination of IgM antibodies in human serum to Epsien Barr Virus (recombinant) Nuclear antigen (EBNA-1) antigen. The 78 EBNA-1 IgM assay should be used in conjunction with other Epstein-Barr serologies (VCA IgM, VCA IgG, EA-D IgG, EBNA-1 IgG and heterophile) as an aid in the diagnosis of infectious mononucleosis. The test can be performed either manually or in conjunction with the MAGO PLUS TM Automated EIA Processor.
Principle of Procedure:
The & EBNA-1 IgM ELISA Kit is an enzyme-linked immunosorbent assay to detect IgM to EBNA-1 in human serum. Recombinant EBNA-1 antigen is attached to a solid phase (microtiter well). Diluted test sera are added to each well. If antibodies which recognize the, EBNA-1 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. An enzyme labeled anti-human 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 prior step, the reaction is stopped and the, color intensity is measured photometrically producing an indirect detection of the specific antibody present in the patient sample.
1
Performance Characteristics
A. Clinical Sensitivity and Specificity Using Characterized Sera
Frozen retrospective sera from one hundred and seventy-six patients were characterized using commercially available kits for VCA IgM, VCA IgG, EBNA-1 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-1 IgG antibodies and negative for VCA IgM and heterophile antibody.
-
- 32 sera were characterized as seronegative. These were negative for VCA IgM, EBNA-1 IgG and hetcrophile antibody.
-
- 42 sera were characterized as having a current (recent) infection. These were positive for VCA IgM and/or heterophile antibody and were negative for EBNA-1 IgG.
All 176 sera were then tested by an independent clinical commercial laboratory using the Is-EBNA-1 IgM Test Kit. The results obtained are shown in Table 2:
| | TABLE 2 | EBV Serological Status
Convalescent | Current Infection | Seronegative |
|-------|-----------|-----------------------------------------------|-------------------|--------------|
| 1 IgM | POSITIVE | 3 | 22 | 0 |
| | NEGATIVE | 98 | 15 | 32 |
| | EQUIVOCAL | 1 | 5 | 0 |
EBV Serological Status
Is-EBNA-1
| 95% CI | ||
|---|---|---|
| Relative Specificity (Convalescent) | 98/101 = 97.0% | 91.6-99.4 |
| Relative Sensitivity (Current Infection) | 22/37 = 59.5% | 42.1-75.3 |
| Relative Specificity (Seronegative) | 32/32 = 100.0% | 89.1-100.0 |
| Overall Agreement | 152/170 = 89.4% | 84.8-94.0 |
- Equivocal results were excluded from calculations
NOTE : Please be advised that 'relative' refers to the comparison of the assay's results to that assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judginent can be made on the comparison's accuracy to predict disease. Since the above studies were performed on a pre-selected, retrospective population, no calculations for the assay's positive and negative value may be done or inferred,
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B. Precision
To determine the precision of the Is-EBNA IgM Test Kit, three possive sera were assayed ten times cach in three different runs at three different sites. The three sites include: the manufacturer, a research and development laboratory, and a clinical commercial laboratory. The intra- and interassay precision obtained at each site is shown in Tables 3, 4 and 5. The Inter-Site precision is shown in Table 6.
TABLE 3 : Site #1 - 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) | 1.08 | 6.59 | 1.08 | 11.94 | 1.14 | 10.66 | 1.10 | 10.00 |
| B (POS) | 2.58 | 4.58 | 2.48 | 4.91 | 2.59 | 4.22 | 2.55 | 4.85 |
| C (POS) | 1.66 | 6.21 | 1.64 | 4.54 | 1.72 | 5.24 | 1.68 | 5.56 |
| D (NEG) | 0.82 | 7.29 | 0.80 | 7.35 | 0.90 | 5.01 | 0.84 | 8.18 |
| E (NEG) | 0.13 | 15.38 | 0.13 | 14.16 | 0.15 | 19.30 | 0.14 | 16.74 |
| F (NEG) | 0.05 | 37.60 | 0.03 | 48.41 | 0.04 | 45.95 | 0.04 | 44.75 |
| CAL | 1.00 | 5.37 | ||||||
| PC | 1.44 | 9.85 | ||||||
| NC | 0.23 | 12.74 |
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) | 1.053 | 3.51 | 1.054 | 5.00 | 1.167 | 4.36 | 1.091 | 6.51 |
| B (POS) | 2.350 | 5.67 | 2.416 | 4.92 | 2.584 | 4.41 | 2.450 | 6.32 |
| C (POS) | 1.596 | 5.78 | 1.582 | 2.26 | 1.685 | 6.26 | 1.621 | 5.75 |
| D (NEG) | 0.783 | 5.20 | 0.757 | 3.58 | 0.866 | 5.92 | 0.802 | 7.69 |
| E (NEG) | 0.132 | 11.04 | 0.113 | 11.94 | 0.145 | 13.55 | 0.130 | 15.67 |
| F (NEG) | 0.045 | 23.75 | 0.047 | 25.57 | 0.058 | 42.15 | 0.050 | 34.34 |
| CAL | 1.001 | 1.91 | ||||||
| PC | 1.329 | 6.12 | ||||||
| NC | 0.149 | 7.52 |
n = 3
12.06
| 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) | 1.07 | 21.03 | 1.10 | 20.91 | 1.11 | 26.05 | 1.09 | 22.09 |
| B (POS) | 2.69 | 3.74 | 2.74 | 4.19 | 2.75 | 5.35 | 2.73 | 4.43 |
| C (POS) | 1.66 | 8.60 | 1.72 | 7.68 | 1.67 | 8.97 | 1.68 | 8.27 |
| D (NEG) | 0.85 | 21.51 | 0.84 | 6.72 | 0.80 | 7.87 | 0.83 | 13.78 |
| E (NEG) | 0.17 | 88.30 | 0.12 | 13.61 | 0.14 | 16.31 | 0.14 | 62.45 |
| F (NEG) | 0.04 | 28.22 | 0.04 | 24.64 | 0.04 | 18.92 | 0.04 | 23.91 |
| CAL | 1.00 | 6.14 | ||||||
| PC | 1.25 | 1.22 |
NC
0.25
Table 6 : Inter-Site Precision
| SERUM
| (n=90) | INTER-SITE | |
|---|---|---|
| MEAN | ||
| INDEX | CV% | |
| A (POS) | 1.09 | 14.33 |
| B (POS) | 2.58 | 6.80 |
| C (POS) | 1.66 | 6.80 |
| D (NEG) | 0.82 | 10.37 |
| E (NEG) | 0.14 | 39.85 |
| F (NEG) | 0.04 | 36.64 |
| CAL (n=36) | 1.00 | 4.12 |
| LPC (n=18) | 1.33 | 7.42 |
| NC (n=18) | 0.18 | 26.86 |
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C. Specificity with Potentially Cross-Reactive Sera
Thirtecn sera, reactive for IgM antibodies to varicella zoster, cytomegalovirus and herpes simplex virus by EIA were tested in the Is-EBNA-1 IgM Test Kit. 4/4 anti-VZV IgM positive sera were non-reactive for anti-EBNA-1 1gM; 2/5 anti-CMV IgM positive sera were non-reactive for anti-EBNA-1 IgM and 4/4 anti-HSV positive sera were non-reactive for anti-EBNA IgM. This suggests that some specific cross-reactivity should be cxpccted with the Is-EBNA-I IgM Test Kit from these analytes.
D. Correlation of Manual and MAGO Plus Results
The Is-EBNA-1 IgM 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 129 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 Coefficient of 0.985.
Image /page/3/Figure/4 description: This image is a scatter plot that shows the relationship between MAGO PLUS INDEX VALUES and MANUAL INDEX VALUES. The x-axis represents MANUAL INDEX VALUES, and the y-axis represents MAGO PLUS INDEX VALUES. The plot includes a regression line with the equation Y = 0.0186 + 0.9826 X, and the correlation coefficient r = 0.985.
FIGURE 3 : Manual and MAGO Plus Result Correlation
E. MAGO Plus Precision
The precision of the assay when performed on the MAGO Plus Automated EIA Processor was determined by assaying six sera ten times each in three different runs. Table 7 shows the intra-and interassay precision obtained using the MAGO Plus.
TABLE 7 : 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) | 1.1 | 8.09 | 1.2 | 5.56 | 1.2 | 10.39 | 1.2 | 10.15 | |
| B (POS) | 2.5 | 4.77 | 2.9 | 3.94 | 2.8 | 7.59 | 2.7 | 8.11 | |
| C (POS) | 1.7 | 6.15 | 1.9 | 3.51 | 1.9 | 6.56 | 1.8 | 7.84 | |
| D (NEG) | 0.9 | 5.55 | 0.9 | 5.49 | 0.9 | 7.26 | 0.9 | 6.88 | |
| E (NEG) | 0.2 | 23.42 | 0.1 | 36.89 | 0.2 | 16.64 | 0.2 | 27.42 | |
| F (NEG) | 0.1 | 0.00 | 0.0 | 129.10 | 0.1 | 69.01 | 0.1 | 66.58 | |
| CAL | 1.0 | 4.88 | n = 9 | ||||||
| PC | 1.2 | 4.95 | n = 3 | ||||||
| NC | 0.3 | 0.00 | n = 3 |
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a series of interconnected shapes.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 25 1998
Norman Jenkins President Columbia Bioscience, Inc. 8775 M Centre Park Drive, #559 Columbia, Maryland 21045
Re: K982348 Device: EBNA-1 IgM ELISA Test System Dated: September 22, 1998 Received: September 28, 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours.
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number: Not Known
Device Name: & EBNA-1 IgM ELISA
Indications For Use: For the qualitative determination of IgM antibodies in human serum to Epstien Barr (recombinant) nuclear antigen (EBNA-1) antigen. The & EBNA-1 IgM assay should be used in conjunction with other Epstein-Barr serologies (VCA IgM, VCA IgG, EA-D IgG, EA-D M, EBNA-1 G and heterophile) as an aid in the diagnosis of infectious mononucleosis. The test can be performed either manually or in conjunction with the MAGO PLUS ™ Automated EIA Processor.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ============================================================================================================================================================================ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The Counter Use (Optional Format 1-2-96)
Woody Dubris
510(k) Number