(16 days)
An enzyme-linked immunosorbent assay (ELISA) for the determination of IgA anti-cardiolipin antibodies in human serum or plasma. For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
An enzyme-linked immunosorbent assay (ELISA) for the determination of IgA anti-cardiolipin antibodies in human serum or plasma.
While the document confirms that the REAADS IgA Anti-Cardiolipin Semi-Quantitative Test Kit is approved for marketing, it does not contain the detailed study information required to answer your request fully.
Specifically, the document is a 510(k) clearance letter, which indicates substantial equivalence to a predicate device but does not typically include the full clinical study report, acceptance criteria, or performance data in the level of detail you've requested.
Therefore, many of your questions cannot be answered from the provided text.
Here's what can and cannot be answered based on the input:
What can be answered:
- Device Name: REAADS IgA Anti-Cardiolipin Semi-Quantitative Test Kit
- Indications for Use: An enzyme-linked immunosorbent assay (ELISA) for the determination of IgA anti-cardiolipin antibodies in human serum or plasma. For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
- Study type implied: The 510(k) clearance implies that a study was conducted to demonstrate substantial equivalence to a predicate device, but the details of that study are not present.
What cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not in the document.
- Sample size used for the test set and the data provenance: This information is not in the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not in the document.
- Adjudication method for the test set: This information is not in the document.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is an ELISA test kit, not an AI-assisted diagnostic imaging device for human readers. Therefore, an MRMC study related to AI assistance is not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is an in-vitro diagnostic (IVD) test kit, not an algorithm. Standalone performance is inherent in its design as an automated assay, but specific "standalone study" details are not provided.
- The type of ground truth used: This information is not in the document. For an ELISA, ground truth would typically be established by a combination of clinical diagnoses and potentially other established laboratory methods, but specifics are missing.
- The sample size for the training set: This information is not in the document. (For an IVD kit, "training set" might refer to assay development and optimization, not machine learning training).
- How the ground truth for the training set was established: This information is not in the document.
To obtain the detailed study information you're looking for, you would typically need to consult the full 510(k) submission summary or associated clinical studies, which are not included in this FDA clearance letter.
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Image /page/0/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nanci Dexter Director of Quality and Regulatory Affairs Corgenix 12061 Tejon Street Westminister, CO 80234
K022990 Re:
Trade/Device Name: REAADS IgA Anti-Cardiolipin Semi-Quantitative Test Kit Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MID Dated: September 5, 2002 Received: September 9, 2002
SFP 2 5 2002
Dear Ms. Dexter:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrlvdsma/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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Indications for Use Statement
K022990 510(k) Number:
Device Name: REAADS IgA Anti-Cardiolipin Semi-Quantitative Test Kit Indications for Use:
An enzyme-linked immunosorbent assay (ELISA) for the determination of IgA anti-cardiolipin antibodies in human serum or plasma.
For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Deborah M. Moore
(Division Sign-Off) Division of Clinical Laboratory 510(k) Number -
Prescription Use /
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
Special 510(k): REAADS IgA Anti-Cardiolipin Semi-Quantitative Test Kit
§ 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).