(125 days)
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.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "Autostat II Anti-Cardiolipin IgM ELISA" device. It does not contain any information regarding acceptance criteria, study details, performance data, or ground truth establishment. The letter confirms that the device is substantially equivalent to a legally marketed predicate device and can proceed to market, subject to general controls and potential additional controls for Class II devices.
Therefore, an answer based solely on the provided text will indicate a lack of this information.
Here's an example of how to frame the answer given the absence of information in the document:
Based on the provided FDA 510(k) clearance letter (K992449) for the Autostat II Anti-Cardiolipin IgM ELISA, the following information regarding acceptance criteria and the study that proves the device meets them is not available:
- A table of acceptance criteria and the reported device performance: This document is an FDA clearance letter confirming substantial equivalence, not a summary of the performance study itself. Therefore, specific acceptance criteria or detailed performance metrics (like sensitivity, specificity, accuracy, etc.) are not presented.
- Sample size used for the test set and the data provenance: The letter does not describe any specific test set size or whether the data was retrospective or prospective, nor does it mention the country of origin.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of expert involvement in establishing ground truth for any test set.
- Adjudication method for the test set: The document does not describe any adjudication methods.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This device is an ELISA assay for antibodies, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, an MRMC study or AI-related metrics are not applicable and are not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As an ELISA kit, the concept of "standalone algorithm performance" (without human-in-the-loop) as typically applied to AI/software devices is not relevant. The device is a laboratory assay.
- The type of ground truth used: The letter does not specify how the "ground truth" (e.g., actual presence of antiphospholipid syndrome or elevated anti-cardiolipin antibodies) was established in any studies supporting this clearance. It states the assay can be used as an aid in diagnosis and that autoantibody levels are one indicator in a multi-factorial diagnostic regime, implying the need for clinical correlation rather than the assay being the sole determinant of ground truth.
- The sample size for the training set: There is no mention of a training set or its size in the context of this device.
- How the ground truth for the training set was established: No information regarding a training set or its ground truth establishment is provided.
The FDA 510(k) process primarily evaluates a device's substantial equivalence to a predicate device, and while performance data is part of the submission, this clearance letter itself does not detail that data.
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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)
§ 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).