(43 days)
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No
The summary describes a standard immunoassay kit and an automated instrument for performing the assay. There is no mention of AI, ML, or any related technologies in the intended use, device description, or other sections.
No
This device is an in vitro diagnostic (IVD) device used for the semi-quantitative determination of specific IgA autoantibodies in human serum, aiding in the diagnosis of autoimmune diseases. It is not designed to treat, cure, prevent or mitigate disease, but rather to provide diagnostic information.
Yes
The "Intended Use / Indications for Use" states that the assay can be "used as an aid in the diagnosis of auto-immune diseases."
No
The device is an in vitro diagnostic (IVD) assay kit, which is a physical product containing reagents and intended for use with a specific instrument. It is not described as software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "semi-quantitative determination of specific IgA autoantibodies to ß2-Glycoprotein I (ß2-GPI) antibodies in human serum." This is a test performed on a biological sample (serum) outside of the body to provide information about a person's health.
- Uses: The uses further clarify that the results are used "as an aid in the diagnosis of auto-immune diseases associated with elevated levels of anti-ß-2 GPI antibodies including antiphospholipid syndrome." This directly relates to diagnosing a medical condition.
- 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 in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA autoantibodies to ß2-Glycoprotein I (ß2-GPI) antibodies in human serum.
Uses:
The results of the anti- ß -2 GPI assay can be used as an aid in the diagnosis of auto-immune diseases associated with elevated levels of anti-ß-2 GPI antibodies including antiphospholipid syndrome. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
This device can be used with the HYCOR HY.TEC automated EIA instrument.
For in vitro diagnostic use only.
Product codes
MSV
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
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Key Metrics
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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).
0
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, featuring three parallel lines that curve and merge into a single line at the bottom.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Danielle M. Knight Quality Manager, Hycor Biomedical Ltd.. Pentlands Science Park Bush Loan Penicuik Midlothian EH26 OPL Scotland, UK
MAR 2 1 2003
K030397 Re:
Trade/Device Name: Autostat II Anti-B-2 Glycoprotein I IGA Elisa Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MSV Dated: February 3, 2003 Received: February 6, 2003
Dear Ms. Knight:
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).
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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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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
2
Indications for Use.
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA autoantibodies to ß2-Glycoprotein I (ß2-GPI) antibodies in human serum.
Uses:
The results of the anti- ß -2 GPI assay can be used as an aid in the diagnosis of auto-immune diseases associated with elevated levels of anti-ß-2 GPI antibodies including antiphospholipid syndrome. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
This device can be used with the HYCOR HY.TEC automated EIA instrument.
For in vitro diagnostic use only.
(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__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
A.P. Revera for J. Bautista
inical I aborato 510k) Number