(75 days)
K981021/S1
Not Found
No
The document describes a standard ELISA test system for detecting antibodies and does not mention any AI or ML components.
No
The device is described as an "enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgM autoantibodies to cardiolipin" and is explicitly stated as being "for in vitro diagnostic use." This means it is used to diagnose or aid in the diagnosis of disorders by measuring substances in a patient's body (like antibodies), rather than treating a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Detection of these autoantibodies may aid in the diagnosis of such disorders" and "This test is for in vitro diagnostic use."
No
The device description clearly states it is an "enzyme-linked immunosorbent assay (ELISA) Test System," which is a laboratory-based assay involving physical reagents and equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The statement explicitly says, "This test is for in vitro diagnostic use."
- Device Description: The description details an "enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgM autoantibodies to cardiolipin." This describes a test performed on a biological sample (circulating antibodies) outside of the body, which is the definition of an in vitro diagnostic.
- Intended User/Care Setting: The mention of "in vitro diagnostic use" further reinforces its classification as an IVD.
N/A
Intended Use / Indications for Use
Autoantibodies directed against phospholipids, and anti-cardiolipin (aCL) in particular, have been associated with recurrent thrombosis, thrombocytopenia, and spontaneous abortions. Detection of these autoantibodies may aid in the diagnosis of such disorders. The Zeus Scientific, Inc. anti-Cardiolipin IgM ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgM autoantibodies to cardiolipin. This test is for in vitro diagnostic use.
Product codes
MID
Device Description
The Zeus Scientific, Inc. anti-Cardiolipin IgM ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgM autoantibodies to cardiolipin.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K981021/S1
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows a logo or emblem that includes the words "DEPARTMENT OF HEALTH" arranged vertically along the left side. To the right of the text is a stylized graphic consisting of three curved lines or shapes, stacked vertically. The overall design appears to be a combination of text and abstract elements, possibly representing a health-related organization or department.
2 1998 JUN
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Mark J. Kopnitsky Vice President, Research and Development Zeus Scientific, Inc. 200 Evans Way Branchburq, New Jersey 08876
Re : K981021/S1 Anti-Cardiolipin IgM ELISA Test System Trade Name: Requlatory Class: II Product Code: MID Dated: May 20, 1998 Received: May 21, 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 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 requirement, 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.
1
Paqe 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 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
2
Page
510(k) Number (if known): 198107 |
The Zeus Scientific, Inc. anti-Cardiolipin IgM ELISA Test System Device Name:
Indications for Use:
Autoantibodies directed against phospholipids, and anti-cardiolipin (aCL) in particular, have been associated with recurrent thrombosis, thrombocytopenia, and spontaneous abortions. Detection of these autoantibodies may aid in the diagnosis of such disorders. The Zeus Scientific, Inc. anti-Cardiolipin IgM ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgM autoantibodies to cardiolipin. This test is for in vitro diagnostic use.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
eborah Moore, Acting Branch Chief
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981021
Prescription Use (Per 21 CFR 801,109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)