(107 days)
Not Found
None
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML technology in medical devices.
No
The device is described as an "in-vitro measurement of IqA anticardiolipin antibodies in human serum, as an aid in the diagnosis of antiphospholipid syndrome (APS)." This indicates a diagnostic purpose, not a therapeutic one. Therapeutic devices are used for treatment, remediation, or prevention of disease.
Yes
The device is described as an "aid in the diagnosis of antiphospholipid syndrome (APS)," which directly indicates its role in diagnostics.
No
The intended use describes an in-vitro measurement of antibodies in human serum, which inherently requires a physical laboratory test and associated hardware (e.g., ELISA plate reader, reagents). The summary does not describe any software component that would perform this measurement independently of physical hardware.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
The key indicator is the "Intended Use / Indications for Use" statement:
"in-vitro measurement of IqA anticardiolipin antibodies in human serum, as an aid in the diagnosis of antiphospholipid syndrome (APS)."
This clearly states that the device is intended for:
- In-vitro measurement: This means the testing is performed outside of the living body, on samples like serum.
- Measurement of a substance (IqA anticardiolipin antibodies): This is a biological marker.
- In a human sample (serum): This is a human specimen.
- As an aid in diagnosis: This indicates a medical purpose related to identifying a disease or condition.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
in-vitro measurement of IqA Use: The Indications for anticardiolipin antibodies in human serum, as an aid in the diagnosis of antiphospholipid syndrome (APS).
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.)
Not Found
Predicate Device(s)
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Reference Device(s)
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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
Public Health Service
Image /page/0/Picture/2 description: The image shows a partial view of a logo, specifically the emblem of the U.S. Department of Health and Human Services (HHS). The emblem features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the wings. The word "DEPARTMENT" is partially visible, oriented vertically along the left edge of the image, indicating the logo is likely for a government department.
5 1959 FEB
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
The Binding Site, Limited C/O Mr. Jay H. Geller East Tower, Suite 600 2425 West Olympic Boulevard Santa Monica, California 90404
Re: K983696 Trade Name: Anticardiolipin IgA Screen EIA Kit Regulatory Class: II Product Code: MID Dated: January 12, 1999 Received: January 20, 1999
Dear Mr. Geller:
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 (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 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 (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
2
INDICATIONS FOR USE STATEMENT
BINDAZYME® Anticardiolipin IgA EIA Kit Device Name:
in-vitro measurement of IqA Use: The Indications for anticardiolipin antibodies in human serum, as an aid in the diagnosis of antiphospholipid syndrome (APS).
Peter E. Makin
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number _ 9831.91