(314 days)
K974244/S2
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No
The document describes a standard enzyme immunoassay (ELISA) test for detecting antibodies. There is no mention of AI, ML, or any computational analysis beyond standard statistical calculations for performance metrics.
No.
The device is described as an enzyme immunoassay (EIA) intended for the serodiagnosis of infectious mononucleosis and presumptive serodiagnosis of CMV mononucleosis-like syndrome, which means it is a diagnostic tool, not a therapeutic one.
Yes
The device is an immunoassay that detects antibodies to aid in the serodiagnosis of infectious mononucleosis and presumptive serodiagnosis of CMV mononucleosis-like syndrome. This clearly indicates its use in identifying or confirming the presence of a disease or condition.
No
The device description clearly states it is an ELISA test method, which is a laboratory-based assay involving physical reagents and procedures, not a software-only device.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is a "qualitative enzyme immunoassay (EIA) that detects IgM antibodies..." and is used "as an aid in the serodiagnosis of infectious (EBV) mononucleosis and presumptive serodiagnosis of CMV mononucleosis-like syndrome." This clearly indicates that the device is intended for use in vitro (outside the body) to diagnose or aid in the diagnosis of a disease or condition.
- Device Description: The "Device Description" further confirms this by stating it is an "ELISA test method detecting heterophile, viral capsid antigen and cytomegalovirus IgM antibodies." ELISA is a common in vitro diagnostic technique.
- Performance Studies: The description of performance studies involving testing of samples (sera) is consistent with the evaluation of an IVD.
Therefore, the Mono M Test, as described, fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Mono M Test is a qualitative enzyme immunoassay (EIA) that detects IgM antibodies to Paul-Bunnell heterophil, Epstein-Barr virus capsid antigen (EBV-VCA), and cytomegalovirus (CMV). When used in conjunction with Mono-G Test, it is as an aid in the serodiagnosis of infectious (EBV) mononucleosis and presumptive serodiagnosis of CMV mononucleosis-like syndrome.
This assay has not been FDA cleared or approved for the screening of blood or plasma donors. Performance with this device has not been established for either prenatal screening or newborn testing. Performance for this assay has not been established in a non-clinical laboratory environment (e.g., point of care testing).
Product codes (comma separated list FDA assigned to the subject device)
LSE
Device Description
The product is an ELISA test method detecting heterophile, viral capsid antigen and cytomegalovirus IgM 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)
A prospective study was performed to assess assay performance. Site A information based on profile comparison is presented in Table 1. Site B information is shown in Table 2 and the combined data can be seen in Table 3.
Table 1: Site A EBV Performance shows:
ImmunoDOT Negative: 33 (Reference Negative), 0 (Reference Current), 1 (Reference Past/Recent)
ImmunoDOT Current: 2 (Reference Negative), 23 (Reference Current), 1 (Reference Past/Recent)
ImmunoDOT Past/Recent: 0 (Reference Negative), 1 (Reference Current), 112 (Reference Past/Recent)
ImmunoDOT Indeterminate: 0 (Reference Negative), 6 (Reference Current), 7 (Reference Past/Recent)
Table 2: Site B EBV Performance shows:
ImmunoDOT Negative: 9 (Reference Negative), 0 (Reference Current), 0 (Reference Past/Recent)
ImmunoDOT Current: 1 (Reference Negative), 10 (Reference Current), 1 (Reference Past/Recent)
ImmunoDOT Past/Recent: 0 (Reference Negative), 0 (Reference Current), 92 (Reference Past/Recent)
ImmunoDOT Indeterminate: 2 (Reference Negative), 0 (Reference Current), 1 (Reference Past/Recent)
Table 3: EBV Performance Summary shows:
ImmunoDOT Negative: 42 (Reference Negative), 0 (Reference Current), 1 (Reference Past/Recent)
ImmunoDOT Current: 3 (Reference Negative), 33 (Reference Current), 2 (Reference Past/Recent)
ImmunoDOT Past/Recent: 0 (Reference Negative), 1 (Reference Current), 204 (Reference Past/Recent)
ImmunoDOT Indeterminate: 2 (Reference Negative), 6 (Reference Current), 8 (Reference Past/Recent)
There was no toxoplasma IM cases identified during the prospective trial period. Two CMV mononucleosis cases at Site A and three CMV mononucleosis cases at Site B were observed. Three of the five sera from presumptive CMV mononucleosis cases were positive according to reference results. These CMV results are included in Table 4 as ImmunoDOT current positives and summarize overall ImmunoDOT performance.
Table 4: Overall Performance Summary shows:
ImmunoDOT Negative: 42 (Reference Negative), 0 (Reference Current), 1 (Reference Past/Recent)
ImmunoDOT Current: 5 (Reference Negative), 36 (Reference Current), 2 (Reference Past/Recent)
ImmunoDOT Past/Recent: 0 (Reference Negative), 1 (Reference Current), 199 (Reference Past/Recent)
ImmunoDOT Indeterminate: 2 (Reference Negative), 6 (Reference Current), 8 (Reference Past/Recent)
The intensity of the dot is directly related to precision. The darkest dots are most reliable while weaker reactions are proportionately less reliable. Site A and Site B laboratories were supplied masked specimens containing mixtures of the various analytes. Therefore, not all analytes tested the same number of replicates. Testing was conducted in triplicate each day. Tests were performed on six different days. The results are shown below. The results (Tables 12 and 13) show adequate qualitative discrimination for each analyte.
Table 6: ImmunoDOT Mono M Precision Results shows:
Antibody Level Moderate: Heterophil 100% (36/36), Level 2 Heterophil 100% (36/36), VCA IgM 100% (36/36), CMV IgM 100% (72/72)
Antibody Level Low: Heterophil 100% (108/108), Level 2 Heterophil 100% (108/108), VCA IgM 100% (72/72), CMV IgM 100% (144/144)
Table 7: ImmunoDOT Mono G Precision Results shows:
Antibody Level Moderate: VCA IgG 100% (144/144), EBNA IgG 100% (36/36), CMV IgG 100% (144/144), Toxoplasma IgG 100% (72/72)
Antibody Level Low: VCA IgG 100% (72/72), EBNA IgG 100% (144/144), CMV IgG 100% (72/72), Toxoplasma IgG 85% (122/144)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Table 5: Performance Characteristics shows (Indeterminate results are not used for the calculations):
EBV Infectious Mononucleosis: Sensitivity 98.8% (238/241), Sensitivity Range 96-99.7%, Specificity 93% (42/45), Specificity Range 93-99%
Mononucleosis Syndrome: Sensitivity 98.7% (236/239), Sensitivity Range 96-99.7%, Specificity 89% (42/47), Specificity Range 77-96%
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.
K974244/S2
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.
Not Found
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).
Not Found
§ 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
| Contact | Bryan Kiehl |
|---|---|
| Address | GenBio |
| 15222-A Avenue of Science | |
| San Diego, CA 92128 | |
| Telephone | (619) 592-9300 ext 309 |
| FAX | (619) 592-9400 |
| Bryan@GenBio.com | |
| Date: | 17 September, 1998 |
| DEVICE NAME | IMMUNODOT MONO M TEST |
|---|---|
| Common, usual, or classification name | Mononucleosis Test |
| Classification Number (if known) |
Identification of the legally marketed device substantial equivalence is claimed: ImmunoDOT Infectious Mononucleosis Test, GenBio, San Diego, CA
Description of the new device:
The product is an ELISA test method detecting heterophile, viral capsid antigen and cytomegalovirus IgM antibodies.
Intended Use of New Device:
The Mono M Test is a qualitative enzyme immunoassay (EIA) that detects IgM antibodies to Paul-Bunnell heterophil, Epstein-Barr virus capsid antigen (EBV-VCA), and cytomegalovirus (CMV). When used in conjunction with Mono-G Test, it is as an aid in the serodiagnosis of infectious (EBV) mononucleosis and presumptive serodiagnosis of CMV mononucleosis-like syndrome.
This assay has not been FDA cleared or approved for the screening of blood or plasma donors. Performance with this device has not been established for either prenatal screening or newborn testing. Performance for this assay has not been established in a non-clinical laboratory environment (e.g., point of care testing).
1
Similarities and/or differences
| ITEM | PREDICATE DEVICE | NEW DEVICE |
|---|---|---|
| Methodology | ELISA | ELISA |
| Specimen Type | Serum | Serum |
| Test Objective | Mononucleosis Serology | Mononucleosis Serology |
| Product type, e.g., | ||
| calibrator, control, kit | Kit | Kit |
| Intended Use | Mononucleosis Serodiagnosis | Mononucleosis Serodiagnosis |
| Other | EBV, CMV and toxoplasma | |
| infections. IgG and IgM are | ||
| detected within one assay. | EBV, CMV and toxoplasma | |
| infections. IgG and IgM are | ||
| detected separately but | ||
| reported together. |
Relative Performance
A prospective study was performed to assess assay performance. Site A information based on profile comparison is presented in Table 1. Site B information is shown in Table 2 and the combined data can be seen in Table 3.
| Reference Results | |||
|---|---|---|---|
| ImmunoDOT | Negative | Current | Past/Recent |
| Negative | 33 | 0 | 1 |
| Current | 2 | 23 | 1 |
| Past/Recent | 0 | 1 | 112 |
| Indeterminate | 0 | 6 | 7 |
Table 1: Site A EBV Performance
2
| Reference Results | |||
|---|---|---|---|
| ImmunoDOT | Negative | Current | Past/Recent |
| Negative | 9 | 0 | 0 |
| Current | 1 | 10 | 1 |
| Past/Recent | 0 | 0 | 92 |
| Indeterminate | 2 | 0 | 1 |
Table 2: Site B EBV Performance
Table 3: EBV Performance Summary
| Reference Results | |||
|---|---|---|---|
| ImmunoDOT | Negative | Current | Past/Recent |
| Negative | 42 | 0 | 1 |
| Current | 3 | 33 | 2 |
| Past/Recent | 0 | 1 | 204 |
| Indeterminate | 2 | 6 | 8 |
There was no toxoplasma IM cases identified during the prospective trial period. Two CMV mononucleosis cases at Site A and three CMV mononucleosis cases at Site B were observed. Three of the five sera from presumptive CMV mononucleosis cases were positive according to reference results. These CMV results are included in Table 4 as ImmunoDOT current positives and summarize overall ImmunoDOT performance.
| ImmunoDOT | Negative | Current | Past/Recent |
|---|---|---|---|
| Negative | 42 | 0 | 1 |
| Current | 5 | 36 | 2 |
| Past/Recent | 0 | 1 | 199 |
| Indeterminate | 2 | 6 | 8 |
Table 4: Overall Performance Summary
Using the above information, assay performance characteristics are shown in Table 5. Indeterminate results are not used for the calculations.
3
| | Sensitivity | Sensitivity
Range | Specificity | Specificity
Range |
|------------------------------|-----------------|----------------------|-------------|----------------------|
| EBV Infectious Mononucleosis | 98.8% (238/241) | 96-99.7% | 93% (42/45) | 93-99% |
| Mononucleosis Syndrome | 98.7% (236/239) | 96-99.7% | 89% (42/47) | 77-96% |
Table 5: Performance Characteristics
r a a
The intensity of the dot is directly related to precision. The darkest dots are most reliable while weaker reactions are proportionately less reliable. Site A and Site B laboratories were supplied masked specimens containing mixtures of the various analytes. Therefore, not all analytes tested the same number of replicates. Testing was conducted in triplicate each day. Tests were performed on six different days. The results are shown below. The results (Tables 12 and 13) show adequate qualitative discrimination for each analyte.
Table 6: ImmunoDOT Mono M Precision Results
| Antibody Level | Level 1 | Level 2 | VCA IgM | CMV IgM |
|---|---|---|---|---|
| Heterophil | Heterophil | |||
| Moderate | 100% | 100% | 100% | 100% |
| (36/36) | (36/36) | (36/36) | (72/72) | |
| Low | 100% | 100% | 100% | 100% |
| (108/108) | (108/108) | (72/72) | (144/144) |
Table 7: ImmunoDOT Mono G Precision Results
| Antibody Level | VCA IgG | EBNA IgG | CMV IgG | Toxoplasma IgG |
|---|---|---|---|---|
| Moderate | 100% | |||
| (144/144) | 100% | |||
| (36/36) | 100% | |||
| (144/144) | 100% | |||
| (72/72) | ||||
| Low | 100% | |||
| (72/72) | 100% | |||
| (144/144) | 100% | |||
| (72/72) | 85% | |||
| (122/144) |
4
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
SEP 2 2 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 : K974244/S2 Trade Name: ImmunoDOT Mono-M Regulatory Class: I Product Code: LSE Dated: July 7, 1998 Received: July 8, 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 reqistration, listing of devices, qood 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 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, of growisi or other Federal laws or regulations. " receive and
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Page 2
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 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 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
6
Indications for Use
510(k) Number (if known):
Device Name: ImmunoDOT Mono-M
Indications for Use:
The Mono M Test is a qualitative enzyme immunoassay (EIA) that detects IdM antibodies to Paul-Bunnell heterophil, Epstein-Barr virus capsid antigen (EBV-VCA), and cytomegalovirus (CMV). When used in conjunction with Mono-G Test, it is as an aid in the serodiagnosis of infectious (EBV) mononucleosis and presumptive serodiagnosis of CMV mononucleosis-like syndrome.
This assay has not been FDA cleared or approved for the screening of blood or plasma donors. Performance with this device has not been established for either prenatal screening or newborn testing. Performance for this assay has not been established in a non-clinical laboratory environment (e.g., point of care testing).
(Please do not write below this line - Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Wordy Dubois