(157 days)
Not Found
No
The device description and performance studies focus on a rapid latex particle agglutination test, which is a traditional immunoassay method and does not involve AI or ML. There are no mentions of AI, DNN, or ML in the provided text.
No.
This device is an in vitro diagnostic test used to detect antibodies to cytomegalovirus, not to treat a condition.
Yes
The "Intended Use" and "Device Description" sections explicitly state that "CMVgen is an in vitro diagnostic" test for the determination of antibodies to cytomegalovirus. This indicates its use in identifying a medical condition.
No
The device description clearly states it is an "in vitro diagnostic, rapid latex particle agglutination test," which is a physical test kit involving reagents and a physical process, not software.
Yes, the provided text explicitly states that the device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section begins with: "CMVgen is an in vitro diagnostic..."
The "Device Description" section also begins with: "CMVgen is an in vitro diagnostic..."
N/A
Intended Use / Indications for Use
CMVgen is an in vitro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total antibodies (IgG and IgM) to cytomegalovirus (CMV) in human serum or plasma (EDTA) to determine prior exposure to cytomegalovirus. This product is not FDA cleared for use in screening blood or plasma (EDTA) donors.
Product codes
83LJO
Device Description
CMVgen is an in vitro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total antibodies (IgG and IgM) to cytomegalovirus (CMV) in human serum or plasma (EDTA) to determine prior exposure to cytomegalovirus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In a method comparison study performed at UMMC Clinical Microbiology Laboratories (Massachusetts) evaluating 165 serum samples, the sensitivity of CMVgen as compared to a commercially available total antibody test was 97.5%. In a separate study performed at Cambridge University (U.K.) evaluating 131 serum samples (ninety of which were collected from 31 organ transplant recipients who had experienced either a primary CMV infection or a reactivation of CMV post-transplant), the sensitivity of CMVgen as compared to a commercially available IgG EIA test was 91.1%.
In a reproducibility study, panels of 10 serum and plasma samples were tested on 3 consecutive days using the semiquantitative procedure for CMVgen. The results, as defined by the ability to give agreement to within one 2-fold dilution on the replicates, indicated 100% reproducibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 97.5%, 91.1%
Reproducibility: 100%
Predicate Device(s)
K841520 CMVscan
Reference Device(s)
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
§ 866.3175 Cytomegalovirus serological reagents.
(a)
Identification. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.(b)
Classification. Class II (performance standards).
0
1 1998 MAY
SECTION 3 CMVgen - 510(k) SUMMARY (Summary of Safety and Effectiveness)
Submitted by:
Carol Marble Regulatory Affairs Engineer Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: (781) 861-4467 (781) 861-4464 Fax:
Contact Persons:
Carol Marble Phone: (781) 861-4467
Summary Prepared:
November 24, 1997 (Revised on February 23, 1998)
Name of the device:
CMVgen
Classification name(s):
| 866.3175 | Cytomegalovirus serological reagents |
|---|---|
| 83LJO | Antigen, IHA, Cytomegalovirus |
Class II
Identification of predicate device(s):
K841520 CMVscan
Description of the device/intended use(s):
CMVgen is an in vitro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total antibodies (IgG and IgM) to cytomegalovirus (CMV) in human serum or plasma (EDTA) to determine prior exposure to cytomegalovirus. This product is not FDA cleared for use in screening blood or plasma (EDTA) donors.
Statement of How the Technological Characteristics of the Device compare to the Predicate Device:
CMV gen uses the same test principle (passive latex agglutination) as the predicate CMVscan and is substantially equivalent in performance, intended use, and safety and effectiveness with the exception that CMVscan is labeled for use to screen donor specimens.
Summary of Performance Data:
In a method comparison study performed at UMMC Clinical Microbiology Laboratories (Massachusetts) evaluating 165 serum samples, the sensitivity of CMVgen as compared to a commercially available total antibody test was 97.5%. In a separate study performed at Cambridge University (U.K.) evaluating 131 serum samples (ninety of which were collected from 31 organ transplant recipients who had experienced either a primary CMV infection or a reactivation of CMV post-transplant), the sensitivity of CMVgen as compared to a commercially available IgG EIA test was 91.1%.
In a reproducibility study, panels of 10 serum and plasma samples were tested on 3 consecutive days using the semiquantitative procedure for CMVgen. The results, as defined by the ability to give agreement to within one 2-fold dilution on the replicates, indicated 100% reproducibility.
Section 3
CMVgen 510(k)
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a stylized emblem. The emblem features three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
1 1658 MAY
Carol Marble Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173-3190
్
K974456 Re: Trade Name: CMVgen Regulatory Class: II Product Code: LJO Dated: February 23, 1998 Received: February 24, 1998
Dear Ms. Marble:
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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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
3
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: CMVgen
Indications for Use:
CMVgen is an in virro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total antibodies (IgG and IgM) to cytomegalovirus (CMV) in human serum or plasma to determine prior exposure to cytomegalovirus.
This assay has not been FDA cleared for use in screening blood or plasma donors.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Clinical Laboratory Device 510(k) Number _
Prescription Use
(Per 21 CFR 801.019)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Section 2
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CMVgen 510(k)
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