(142 days)
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No
The summary describes a standard Indirect Fluorescence Assay (IFA) and does not mention any AI or ML components in the device description, performance studies, or key metrics.
No.
Explanation: This device is an in-vitro diagnostic (IVD) test intended to detect antibodies to the Epstein-Barr Virus, which aids in the diagnosis of infectious mononucleosis. It does not directly treat or alleviate a disease, nor does it restore, modify, or correct body function or structure.
Yes
The device is intended as an aid in the diagnosis of infectious mononucleosis (IM) by detecting specific antibodies, which aligns with the definition of a diagnostic device.
No
The device description clearly states it is an "Indirect Fluorescence Assay (IFA)" and describes a laboratory test kit for detecting antibodies in human serum. This indicates a physical test kit with reagents and likely requires laboratory equipment (like a fluorescence microscope mentioned as the input imaging modality), not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative and semi-quantitative detection of IgG (Immunoglobulin G) antibody to the early antigen complex of the Epstein-Barr Virus in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a disease state (Epstein-Barr Virus infection).
- Device Description: The description confirms it's an "Indirect Fluorescence Assay (IFA) for the detection of IgG antibodies to EBV-EA in human serum." This further reinforces the in vitro nature of the test.
- Sample Type: The test uses "human serum," which is a biological sample taken from a patient.
- Purpose: The test is used "as an aid in the diagnosis of infectious mononucleosis (IM)," which is a diagnostic purpose.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stellar Bio Systems' Indirect Fluorescence Assay (IFA) for Epstein-Barr Virus Early Antigen (EBV-EA) IgG Antibody is intended for the qualitative and semi-quantitative detection of IgG (Immunoglobulin G) antibody to the early antigen complex of the Epstein-Barr Virus in human serum. The test detects IgG antibodies to EBV antigens in chemically induced Raji cells. The EBV-EA IFA Test Kit should be used in combination with other Epstein-Barr serologies [Viral Capsid Antigen (VCA) IgG and IgM, Epstein-Barr Nuclear Antigen (EBNA), and heterophile antibody] as an aid in the diagnosis of infectious mononucleosis (IM).
Product codes
LSE
Device Description
The Epstein-Barr Virus Early Antigen (EBV-EA) IgG IFA is an Indirect Fluorescence Assay (IFA) for the detection of IgG antibodies to EBV-EA 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
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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
The Stellar EBV-EA IFA kit was evaluated relative to a commercially available EBV-EA IFA. The samples were selected frozen retrospective sera tested at a commercial clinical laboratory. The acute sera were selected by being positive in a heterophile assay. The seronegative sera were selected by being negative for VCA G and EBNA G by ELISA. The seropositive sera were selected by being positive for VCA G and EBNA G by ELISA.
- 25 positive sera were serially two-fold diluted.
- Three positive sera with various titers (1:80,1:160, 1:640) and one negative sera were serially diluted.
- Sera positive for IgG antibodies to CMV, VZV, HSV 1, HSV 2, HHV 6 and HHV 8 by IFA were tested.
Summary of Performance Studies
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Relative Sensitivity and Specificity: The Stellar EBV-EA IFA kit was evaluated relative to a commercially available EBV-EA IFA.
Overall Agreement = 68/75 = 90.7% (81.7% - 96.2% 95% Confidence Interval).
The 6 Stellar positive/Alternate IFA negative samples were acute sera determined by ELISA VCA IgM. -
Titer Agreement: 25 positive sera were serially two-fold diluted and the endpoint titer was determined on the Stellar EBV-EA IFA and a commercially available EBV-EA IFA.
Identical Titer: 9/25.
- one, two-fold dilution: 12/25.
- two, two-fold dilutions: 4/25.
-
Reproducibility: Three positive sera with various titers (1:80,1:160, 1:640) and one negative sera were serially diluted and assayed five times each on three different assays at three different sites.
131/180 of the end point titers were identical. 49/180 of the end point titers was within + one, two-fold dilution. -
Specificity: The following sera that were positive for IgG antibodies to CMV, VZV, HSV 1, HSV 2, HHV 6 and HHV 8 by IFA were found to be negative for EBV-EA IFA, indicating a lack of cross-reactivity to these viruses.
Key Metrics
Relative Sensitivity, Relative Specificity, Overall Agreement.
Absolute values not given, only relative comparison to an alternate IFA.
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
DEC 2 2 1999
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: | July 20, 1999 |
|---|---|
| Name: | Stellar Bio Systems, Inc |
| Address: | 9075 Guilford Road |
| Columbia, MD 21046 | |
| Contact Person: | John Brewer |
| Contact Person: | John Brewer |
|---|---|
| PhoneNumber. | 410-381-8550 |
| Fax Number. | 410-381-8984 |
Device Information:
| Trade Name: | Indirect Fluorescence Assay for Epstein-Barr Virus Early Antigen (EBV-EA) IgG
Antibody |
|----------------------|-------------------------------------------------------------------------------------------|
| Common Name: | EBV-EA IgG IFA Test |
| Classification Name: | EBV-EA IgG Serological Reagent |
Equivalent Device: IFA
Device Description: The Epstein-Barr Virus Early Antigen (EBV-EA) IgG IFA is an Indirect Fluorescence Assay (IFA) for the detection of IgG antibodies to EBV-EA in human serum.
Intended Use: The Stellar Bio Systems' Indirect Fluorescence Assay (IFA) for Epstein-Barr Virus Early Antigen (EBV-EA) IgG Antibody is intended for the qualitative and semi-quantitative detection of IgG (Immunoglobulin G) antibody to the early antigen complex of the Epstein-Barr Virus in human serum. The test detects IgG antibodies to EBV antigens in chemically induced Raji cells. The EBV-EA IFA Test Kit should be used in combination with other Epstein-Barr serologies [Viral Capsid Antigen (VCA) IgG and IgM, Epstein-Barr Nuclear Antigen (EBNA), and heterophile antibody] as an aid in the diagnosis of infectious mononucleosis (IM).
Principle of Procedure:
Stellar Bio Systems' fluorescent antibody assays use the indirect method of antibody detection and titer determination. Diluted patient serum sampled to fixed antigens provided on paint delineated wells on glass microscope slides. During a 30 minute incubation, antibody specific for EA forms an antigen/antibody complex with the fixed antigens. In a brief washing step, nonspecific antibody and other unreacted serum proteins are eliminated. Fluorescein-conjugated goat anti-human IgG is then applied to the glass slide. The anti-IgG conjugate combines with human IgG, if present, during a 30 minute incubation. After a brief wash to remove unreacted conjugate, the slides are viewed by fluorescence microscopy. A positive antibody reaction is denoted by bright green fluorescence at the antigen sites.
1
Performance Characteristics
-
- Relative Sensitivity and Specificity The Stellar EBV-EA IFA kit was evaluated relative to a commercially available EBV-EA IFA. The samples were selected frozen retrospective sera tested at a commercial clinical laboratory. The acute sera were selected by being positive in a heterophile assay. The seronegative sera were selected by being negative for VCA G and EBNA G by ELISA. The seropositive sera were selected by being positive for VCA G and EBNA G by ELISA.. The data in Table 1 summarizes the data.
Table 1 Relative Sensitivity and Specificity of the Stellar EBV-EA IFA Kit Relative to Alternate IFA
| Stellar EBV-EA IFA | ||||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| Positive | 42 | 1 | 43 | |
| Alternate | ||||
| IFA | Negative | 6* | 26 | 32 |
| Total | 48 | 27 | 75 |
95% Confidence Interval Overall Agreement = 68/75 = 90.7% 81.7% - 96.2%
- The 6 Stellar positive/Alternate IFA negative samples were acute sera determined by ELISA VCA IgM.
Please be advised that 'relative' refers to the comparison of this 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.
Since the above studies were performed on a pre-selected retrospective population no calculations for the assay's positive and negative predictive value may be done or inferred.
2
The above sera were categorized relative to their serological status to EBV. The following table illustrates the results:
| | Acute
VCA IgM (+)
EBNA (-) | Seropositive
VCA IgG (+)
EBNA (+) VCA IgM (-) | Seronegative
VCA IgG (-)
EBNA (-) |
|-------------------|----------------------------------|-----------------------------------------------------|-----------------------------------------|
| EBV EA
IgG IFA | | | |
| Positive | 20 | 25 | 3 |
| Negative | 10 | 7 | 10 |
| Total | 30 | 32 | 13 |
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- Titer Agreement: 25 positive sera were serially two-fold diluted and the endpoint titer was determined on the Stellar EBV-EA IFA and a commercially available EBV-EA IFA. The endpoint titer results are as follows.
| Identical Titer | 9/25 |
|---|---|
| + one, two-fold dilution |
-
| 12/25 |
| + two, two-fold dilutions
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 4/25 |
-
- Reproducibility: Three positive sera with various titers (1:80,1:160, 1:640) and one negative sera were serially diluted and assayed five times each on three different assays at three different sites. 131/180 of the end point titers were identical. 49/180 of the end point titers was within + one, two-fold dilution.
4. Specificity
The following sera that were positive for IgG antibodies to CMV, VZV, HSV 1, HSV 2, HHV 6 and HHV 8 by IFA were found to be negative for EBV-EA IFA, indicating a lack of cross-reactivity to these viruses.
| Sample | EA IFA Result |
|---|---|
| CMV + | - |
| VZV + | - |
| HSV 1&2 + | - |
| HSV 1&2 + | - |
| HSV 1&2 + | - |
| HSV 1&2 + | - |
| HHV 6+ | - |
| HHV 6+ | - |
| HHV 8+ | - |
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 22 1999
Mr. John Brewer President Stellar Bio Systems, Inc. 9075 Guilford Road Columbia, Maryland 21046
Re: K992587
Trade Name: Indirect Fluorescence Assay (IFA) for Epstein-Barr Virus Early Antigen (EBV-EA) IgG Antibody Regulatory Class: I
:"... Product Code: LSE Dated: October 29, 1999 Received: October 29, 1999
Dear Mr. Brewer:
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 Sutman
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 (if known): K992587
Device Name: Indirect Fluorescence Assay (IFA) for Epstein-Barr Virus Early Antigen (EBV-EA) IgG Antibody
Indications For Use: The Stellar Bio Systems' Indirect Fluorescence Assay (IFA) for Epstein-Barr Early Antigen (EBV-EA) IgG Antibody is intended for the qualitative and semi-quantitative detection of IgG (Immunoglobulin G) antibody to the early antigen complex of the Epstein-Barr Virus in human serum. The test detects IgG antibodies to both the diffuse (D) and restricted (R) components of the EBV early antigen complex. The EBV-EA IFA Test Kit should be used in combination with other Epstein-Barr serologies (Viral Capsid Antigen (VCA) IgG and IgM, Epstein-Barr Nuclear Antigen (EBNA), and heterophile antibody) as an aid in the diagnosis of infectious mononucleosis (IM).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Duboe
(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number K992587
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)