(70 days)
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No
The summary describes a standard ELISA test kit, which is a laboratory assay and does not mention any computational or algorithmic components indicative of AI/ML.
No
The device is an in vitro diagnostic test designed for the semi-quantitative measurement of autoantibodies, which falls under diagnostic use, not therapeutic.
Yes
The device "aids in the diagnosis of such disorders" by detecting autoantibodies associated with recurrent thrombosis, thrombocytopenia, and spontaneous abortions, as stated in the 'Intended Use / Indications for Use' section.
No
The device description clearly states it is an "enzyme-linked immunosorbent assay (ELISA) test system," which is a laboratory-based diagnostic test involving physical reagents and equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "This test is for in vitro diagnostic use."
Additionally, the "Intended User / Care Setting" section also indicates "in vitro diagnostic use".
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 Detection of these autoantibodies may aid in the spontaneous abortions. The Zeus Scientific, Inc. Cardiolipin IgG/IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgG and IgM autoantibodies to cardiolipin. This test is for in vitro diagnostic use.
Product codes
MID
Device Description
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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)
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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
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§ 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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Mark J. Kopnitsky Vice President, Research and Development Zeus Scientific, Inc. P.O. Box 38 Raritan, New Jersey 08869
JUL 2 3 1997
Re: K971784 Zeus Scientific, Inc., Anti-Cardiolipin IgG/IgM Trade Name: ELISA Test System Regulatory Class: II Product Code: MID Dated: May 12, 1997 Received: May 14, 1997
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, labelinq, 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.
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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 requlation (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 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
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| Labels | Values |
|---|---|
| 510(k) Number (if known): | K971784 |
| Device Name: | Anti-Cardiolipin IgG/IgM Test System |
| Indications For Use: |
Indications for Use:
Autoantibodies directed against phospholipids, and anti-cardiolipin (aCL) in particular, have been associated with recurrent thrombosis, thrombocytopenia, and Detection of these autoantibodies may aid in the spontaneous abortions. diagnosis of such disorders. The Zeus Scientific, Inc. Cardiolipin IgG/IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgG and IgM autoantibodies to cardiolipin. This test is for in vitro diagnostic use.
Peter E. Mafin
(Division Sign-Off)
Division of Industrial Operations
Rev 07/18/97
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
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(Optional Format 1-2-96)