(139 days)
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No
The summary describes a standard immunoassay method and an automated instrument for performing it. There is no mention of AI, ML, or any related concepts in the intended use or other sections.
No
This device is an in vitro diagnostic (IVD) assay designed to detect autoantibodies in human serum, used as an aid in diagnosing autoimmune diseases. It does not provide therapy or treatment.
Yes
The device is described as an "aid in the diagnosis of autoimmune diseases" and states that the results "can be used as an aid in the diagnosis of autoimmune diseases". It also specifies that "levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime" and is "for in vitro diagnostic use only."
No
The device is described as an enzyme-linked immunosorbent assay (ELISA) method, which is a laboratory technique involving physical reagents and instrumentation (Hycor Hy•Tec Automated EIA instrument). This indicates it is a hardware-based in vitro diagnostic device, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's an "Enzyme linked immunosorbent assay method for the detection of IgG, IgM and IgA autoantibodies to cardiolipin in human serum." This involves testing a sample taken from the human body (serum) outside of the body to gain information about a person's health.
- Indications for Use: It states the results can be used "as an aid in the diagnosis of autoimmune diseases associated with elevated levels of anti-cardiolipin antibodies including anti-phospholipid syndrome." This clearly indicates a diagnostic purpose.
- Explicit Statement: The document explicitly states "For in vitro diagnostic use only." This is a definitive declaration that the device is intended for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
Enzyme linked immunosorbent assay method for the detection of IgG, IgM and 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 multi-factorial diagnostic regime. The assay may be used on the Hycor Hy•Tec Automated EIA instrument. For in vitro diagnostic use only.
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
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Key Metrics
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Predicate Device(s)
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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
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above two wavy lines.
1 2000 FEB
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Cogent Diagnostics LTD c/o Mr. Randy Wilson Hycor Biomedical Inc. 7272 Chapman Avenue Garden Grove, California 92841
Re: K993085 Trade Name: Autostat™II ACA Screen ELISA Regulatory Class: II Product Code: MID Dated: November 19, 1999 Received: November 26, 1999
Dear Mr. Wilson:
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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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
Page 2
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" (21CFR 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 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): K993085 Device Name: Jutostag ACA SCREEN ELISA
Indications for Use.
Enzyme linked immunosorbent assay method for the detection of IgG, IgM and 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 multi-factorial diagnostic regime.
The assay may be used on 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)
Stutis E. Madani
(Division Sign-Off)
Division of Clinical Laboratory Devices K993085
510(k) Number
Prescription Use Y (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)