(145 days)
An enzyme linked immunoassay (ELISA) for the detection of IgG, IgA , IgM class anti-cardiolipin antibodies, as an aid in assessing the risk of thrombosis in individuals with anti-phospholipid syndrome.
An enzyme linked immunoassay (ELISA) for the detection of IgG, IgA , IgM class anti-cardiolipin antibodies
The provided document is a 510(k) clearance letter from the FDA for an "Anti-Cardiolipin Antibody (ACA) Screen ELISA." This document explicitly states that it is marketing clearance and refers to the device's substantial equivalence to a predicate device. It does not contain detailed information about a study proving the device meets acceptance criteria, acceptance criteria themselves, or performance metrics in the way a clinical study report or even an FDA summary of safety and effectiveness data would.
Therefore, many of the requested details cannot be extracted from this specific document.
Here's what can be inferred or stated from the document, and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided: This document does not list acceptance criteria or specific performance data (e.g., sensitivity, specificity, accuracy, precision) from a study that would demonstrate the device meets those criteria. The letter focuses on the regulatory decision of substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided: The document does not describe the test set, its sample size, or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Cannot be provided: This information is not present in the letter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided: This information is not present in the letter.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Cannot be provided: This is an in-vitro diagnostic (ELISA) device, not an AI-assisted diagnostic imaging device for human readers. Therefore, an MRMC study related to human reading improvement with AI is not applicable or discussed here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided: Again, this relates to AI/software performance. For an ELISA kit, "standalone performance" generally refers to its analytical and clinical performance when used as intended, not an algorithm's performance. The document does not provide such performance statistics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided: The document does not describe how ground truth was established for any studies that may have been performed. For an in-vitro diagnostic, "ground truth" would typically come from a reference method or clinical diagnosis with follow-up.
8. The sample size for the training set:
- N/A / Cannot be provided: This is an ELISA kit, not a machine learning algorithm that requires a "training set" in the conventional AI sense.
9. How the ground truth for the training set was established:
- N/A / Cannot be provided: As above, the concept of a training set and its ground truth in the context of AI is not directly applicable to an ELISA kit, and no such information is in the document.
Summary from the provided document:
The provided FDA letter is a notification of substantial equivalence for the "Anti-Cardiolipin Antibody (ACA) Screen ELISA" (K970177/S2). It states the device is an enzyme-linked immunoassay for the detection of IgG, IgA, and IgM class anti-cardiolipin antibodies, intended as an aid in assessing the risk of thrombosis in individuals with anti-phospholipid syndrome. The letter indicates that the FDA has reviewed the 510(k) submission and determined the device is substantially equivalent to legally marketed predicate devices.
Crucially, this document does not contain the detailed study results, acceptance criteria, or performance data that would typically be found in a Premarket Approval (PMA) document, a summary of safety and effectiveness data (SSED), or a clinical study report. The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, which implies the predicate device's established safety and effectiveness are transferred.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN | | 1997
Mr. Richard E. Greco, R.A.C. Regulatory Affairs IMMCO Diagnostics, Inc. 963 Kenmore Avenue Buffalo, New York 14223
Re: K970177/S2
Trade Name: Anti-Cardiolipin Antibody (ACA) Screen ELISA 发 Regulatory Class: II Product Code: MID Dated: May 30, 1997 Received: June 5, 1997
Dear Mr. Greco:
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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
Under the Clinical Laboratory (mprovement 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.
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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 Putman
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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510(k) Number (if known): 长970177
Ocvice Name: Anti-Cardiolipin Antibody (ACA) Screen
Indications For Use:
学
An enzyme linked immunoassay (ELISA) for the detection of IgG, IgA , IgM class anti-cardiolipin antibodies, as an aid in assessing the risk of thrombosis in individuals with anti-phospholipid syndrome.
Peter E. Madin
(Division SK 510k) Nu
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Presentation Lise Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ ાં ર (Per 21 CFR 801,109i (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).