(125 days)
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No
The summary describes a standard immunoassay method and instrument without any mention of AI or ML technologies.
No
The device is described as an "Enzyme linked immunosorbent assay method" used for the "semi-quantitative determination of specific IgM autoantibodies to cardiolipin in human serum." It is intended for "in vitro diagnostic use only" to aid in diagnosis, not to provide therapy or treatment.
Yes
The text explicitly states that the assay results "can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-cardiolipin antibodies including antiphospholipid syndrome." and that "Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime."
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 a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document explicitly states "For in vitro diagnostic use only."
- Intended Use: The intended use describes a method for determining specific antibodies in human serum, which is a biological sample tested in vitro (outside the body).
- Diagnostic Aid: The intended use also states that the results can be used as an "aid in the diagnosis of diseases," which is a key characteristic of IVD devices.
N/A
Intended Use / Indications for Use
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgM autoantibodies to cardiolipin in human serum.
Uses:
The results of the anti-cardiolipin assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-cardiolipin antibodies including antiphospholipid 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 (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 shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
NOV 2 4 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Danielle M. Knight Official Correspondent Cogent Diagnostics Ltd. Pentlands Science Park Bush Loan Penicuik EH26 OPL United Kingdom
K992449 Re:
Trade Name: Autostat II Anti-Cardiolipin IgM ELISA Regulatory Class: II Product Code: MID Dated: September 24, 1999 Received: September 29, 1999
Dear Ms. Knight:
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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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
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Page_of_
| 510(k) Number (if known): | K992449 |
|---|---|
| Device Name: | Autostat II |
| Anti-Cardiolipin IgM ELISA |
Indications For Use:
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgM autoantibodies to cardiolipin in human serum.
Uses:
The results of the anti-cardiolipin assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-cardiolipin antibodies including antiphospholipid 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)
Tuta E. Maden
(Division Sign-Off)
Division of Clinical Laboratory Devices K9924-
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)