(299 days)
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No
The summary describes a standard ELISA kit for detecting antibodies and does not mention any AI or ML components or capabilities.
No
The device aids in diagnosis but does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states that the results of the VCA IgG test, especially when used with other tests, "can serve as an aid in the diagnosis of infectious mononucleosis (IM)." This explicitly indicates its role in diagnosis.
No
The device description explicitly states it is a "Microtiter ELISA kit," which is a hardware-based laboratory assay.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the test is for the "qualitative detection of IgG antibody to Epstein-Barr Virus viral capsid antigen (VCA) in human serum by ELISA." This involves testing a sample taken from the human body (serum) outside of the body (in vitro) to provide information about a disease state (diagnosis of infectious mononucleosis).
- Device Description: The "Device Description" confirms it's a "Microtiter ELISA kit detecting VCA IgG antibodies," which is a common format for IVD tests.
- Performance Studies: The "Summary of Performance Studies" discusses non-clinical and clinical performance data, which are standard requirements for demonstrating the effectiveness and safety of an IVD.
- Predicate Device: The mention of a "Predicate Device" (Epstein-Barr Viral Capsid Antigen IgG ELISA Kit) is typical for regulatory submissions of new IVDs, where the new device is compared to an already approved device.
All of these elements strongly indicate that the ImmunoWELL VCA IgG Test is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ImmunoWELL VCA IgG Test is for the qualitative detection of IgG antibody to Epstein-Barr Virus viral capsid antigen (VCA) in human serum by ELISA. When the VCA IgG test is used in conjunction with other testing such as the EBV nuclear antigen (EBNA-1), VCA IgM, and EBV early antigen tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM).
Product codes (comma separated list FDA assigned to the subject device)
LSE
Device Description
Microtiter ELISA kit detecting VCA IgG antibodies
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance data, the summary includes a brief discussion of the nonclinical tests and how their results support a determination of substantial equivalence.
The predicate device and the new device perform essentially the same when testing sera from suspected patients. The observations are:
ImmunoWELL VCA IgG Test
Table 1: Gull EIA
Alternate EIA
| Past/Recent | Current | No Past Infection | ||
|---|---|---|---|---|
| ImmunoWELL | Past/Recent | 65 | 8 | 0 |
| ImmunoWELL | Current | 0 | 7 | 0 |
| ImmunoWELL | No Past Infection | 5 | 1 | 8 |
| Clinical performance data, the summary Includes a brief discussion of clinical tests and how their results support a determination of substantial equivalence. | ||||
| The device used in conjunction with other ImmunoWELL EBV assays (EBNA IgG and VCA IgM) provides clinical information that is substantially the same as serological information using the predicate device. | ||||
| The summary includes the conclusions drawn from the nonclinical and clinical tests. | ||||
| This assay yields results that are essentially the same the predicate device. |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
510(k) Summary AUG | U
| Contact | Bryan Kiehl |
|---|---|
| Address | GenBio |
| 15222-A Avenue of Science | |
| San Diego, CA 92128 | |
| Telephone | (619) 592-9300 ext 309 |
| FAX | (619) 592-9400 |
| BKiehl@GenBio.com | |
| Date: | 10 August, 1998 |
| Device Name | ImmunoWELL VCA IgG Test |
|---|---|
| Common, usual, or classification name | Epstein-Barr Virus Viral Capsid Antigen IgG Test |
| Classification Number (if known) | 866.3235 |
Identification of the legally marketed device substantial equivalence is claimed:
Epstein-Barr Viral Capsid Antigen IgG ELISA Kit, Gull Laboratories, Inc.
Description of the new device:
Microtiter ELISA kit detecting VCA IgG antibodies
Intended Use of New Device:
ImmunoWELL VCA IgG Test is for the qualitative detection of IgG antibudy to Epstein-Barr Virus viral capsid antigen (VCA) in human serum by ELISA. When the VCA IgG rest is used in conjunction with other testing such as the EBV nuclear antigen (EBNA-1), VCA IgM, and EBV early antigen tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM).
Technological characteristics of the new device compared to the predicate device:
The new device and the predicate ElA device are essentially identical. Both use VCA antigens and measure antibodies in a microtiter assay format using ELISA technology.
Non-clinical performance data, the summary includes a brief discussion of the nonclinical tests and how their results support a determination of substantial equivalence.
The predicate device and the new device perform essentially the same when testing sera from suspected patients. The observations are:
ImmunoWELL VCA IgG Test
Page I
1
Table 1: Gull ElA
Alternate EIA
| Past/Recent | Current | No Past Infection | ||
|---|---|---|---|---|
| ImmunoWELL | Past/Recent | 65 | 8 | 0 |
| ImmunoWELL | Current | 0 | 7 | 0 |
| ImmunoWELL | No Past Infection | 5 | 1 | 8 |
Clinical performance data, the summary Includes a brief discussion of clinical tests and how their results support a determination of substantial equivalence.
The device used in conjunction with other ImmunoWELL EBV assays (EBNA IgG and VCA IgM) provides clinical information that is substantially the same as serological information using the predicate device.
The summary includes the conclusions drawn from the nonclinical and clinical tests.
This assay yields results that are essentially the same the predicate device.
2
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with three lines representing the eagle's head and body.
AUG 10 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Bryan L. Kiehl, Ph.D. Vice President GenBio 15222 Avenue of Science, Suite A San Diego, California 92128
Re : K973940/S2 ImmunoWELL® EBV VCA IgG Test Trade Name: Requlatory Class: T Product Code: LSE Dated: May 15, 1998 Received: May 19, 1998
Dear Dr. Kiehl:
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 Requlations, 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 requlation 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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This letter will allow you to beqin 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 requlation 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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
4
FDA Document Number:
Indications for Use
510(k) Number (if known): K973940
Device Name: ImmunoWELL VCA IgG Test
Indications for Use: ImmunoWELL. VCA IgG Test is for the qualitative detection of IgG antibody to Epstein-Barr Virus viral capsid antigen (VCA) in human serum by ELISA. When the VCA IgG test is used in conjunction with other testing such as the EBV nuclear antigen (EBNA-1), VCA IgM, and EBV early antigen tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM).
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubois
(Division sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K973940
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)