(52 days)
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No
The summary describes a standard ELISA assay and an automated instrument for running it, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
No
The device is described as an "Enzyme linked immunosorbent assay method" for in vitro diagnostic use, which means it is used for testing samples outside of the body to aid in diagnosis, not to treat a condition.
Yes
The device is described as an "aid in the diagnosis of autoimmune diseases" and intended "For in vitro diagnostic use only," which explicitly states its diagnostic purpose.
No
The device description clearly states it is an "Enzyme linked immunosorbent assay method," which is a laboratory test 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 description explicitly states "Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA autoantibodies to cardiolipin in human serum." This indicates the device is used to test a sample taken from the human body (serum) outside of the body (in vitro) to provide diagnostic information.
- Uses: It further clarifies that the results "can be used as an aid in the diagnosis of autoimmune diseases." This directly links the device's function to providing information for diagnosis.
- Explicit Statement: The document includes the phrase "For in vitro diagnostic use only." This is a clear and definitive statement that the device is intended for IVD purposes.
- Device Description: The description reiterates the method and the sample type, reinforcing its use in laboratory testing of human samples.
- Anatomical Site: The mention of "human serum" confirms that the device is used to analyze a biological sample taken from a human.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended to be used in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA autoantibodies to cardiolipin in human serum. The results of the anti-cardiolipin assay can be used as an aid in the diagnosis of autoimmune diseases associated with elevated levels of anti-cardiolipin antibodies including anti-phospholipid syndrome. Levels of these autoantibodies are one indicator in a multifactorial diagnostic regime. This device can be used with the HYCOR HY•TEC automated EIA instrument. For in vitro diagnostic use only. Prescription 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)
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Reference Device(s)
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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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY = 1 2003
Ms. Danielle M. Knight Quality Manager Hycor Biomedical Limited Pentlands Science Park Bush Loan Penicuik EH26 OPL United Kingdom
K030741 Trade/Device Name: Autostat™ II Anti-Cardiolipin IgA ELISA Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: II Product Code: MID Dated: March 5, 2003 Received: March 10, 2003
Dear Ms. Knight:
Re:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use.
Autostat™II Anti-Cardiolipin IgA ELISA
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA autoantibodies to cardiolipin in human serum.
Uses:
The results of the anti-cardiolipin assay can be used as an aid in the diagnosis of autoimmune diseases associated with elevated levels of anti-cardiolipin antibodies including anti-phospholipid syndrome. Levels of these autoantibodies are one indicator in a multifactorial diagnostic regime.
This device can be used with the HYCOR HY•TEC automated EIA instrument.
For in vitro diagnostic use only.
Prescription use $\checkmark$
J.P. Leves for J. Bautista
Division Sign Off
vision of Clinical Laboratory De
510(k) Number R-070674