(47 days)
Not Found
Not Found
No
The document describes an ELISA test system, which is a laboratory assay, and there is no mention of AI or ML in the provided text.
No
Explanation: This device is an in vitro diagnostic test system used to detect antibodies for diagnostic purposes, not to treat a condition or disease.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "designed for the manual or automated (Aptus) qualitative determination of IgM antibodies to cytomegalovirus in human serum" and "is intended to be used to evaluate serologic evidence of primary or reactivated infection with CMV and is for in vitro diagnostic use." This clearly indicates its purpose is to diagnose infections.
No
The device is an ELISA test system, which is a laboratory-based assay involving physical reagents and equipment, not solely software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The statement explicitly says "and is for in vitro diagnostic use." This is the most direct indicator.
- Device Name: "CMV IgM ELISA test system" and "enzyme-linked immunosorbent assay (ELISA)" are common terms for laboratory tests performed on biological samples outside of the body.
- Sample Type: The test is designed for use with "human serum," which is a biological sample.
- Purpose: The test is intended to "evaluate serologic evidence of primary or reactivated infection with CMV," which is a diagnostic purpose.
The other sections being "Not Found" or "Not Applicable" do not negate the clear statement in the Intended Use that this is for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The CMV IgM ELISA test system is and enzyme-linked immunosorbent assay (ELISA) designed for the manual or automated (Aptus) qualitative determination of IgM antibodies to cytomegalovirus in human serum. The test is intended to be used to evaluate serologic evidence of primary or reactivated infection with CMV and is for in vitro diagnostic use. This product is not FDA deared (approved) for use in testing (i.e., screening) blood or plasma donors.
Product codes
LFZ
Device Description
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
§ 866.3175 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
Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a family of three figures.
DEC 1 4 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mark J. Kopnitsky Vice President of Research & Development Zeus Scientific, Inc. P.O. Box 38 Raritan, NJ 08869
Re: K983803 Trade Name: Aptus (Automated) Application of the CMV IgM ELISA Test Regulatory Class: II Product Code: LFZ Dated: October 22, 1998 Received: October 28, 1998
Dear Mr. Kopnitsky:
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 OS 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.
1
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
2
Page 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Aptus (automated) Application for the CMV IgM ELISA Test Device Name: System
Indications for Use:
The CMV IgM ELISA test system is and enzyme-linked immunosorbent assay (ELISA) designed for the manual or automated (Aptus) qualitative determination of IgM antibodies to cytomegalovirus in human serum. The test is intended to be used to evaluate serologic evidence of primary or reactivated infection with CMV and is for in vitro diagnostic use. This product is not FDA deared (approved) for use in testing (i.e., screening) blood or plasma donors.
Revised 11-19-98
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801,109)
2-96)
Wooley Dubois
(Optional Format 1-
Division of Clinical Laboratory Devices
510(k) Number K983803