(16 days)
An enzyme-linked immunosorbent assay (ELISA) for the determination of IgG and IgM 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).
Not Found
This document is a 510(k) clearance letter from the FDA for the REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit. It does not contain the detailed study results, acceptance criteria, or performance data that would answer your specific questions about the device's performance characteristics.
The letter states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means the device is considered as safe and effective as a device already on the market, but it does not typically involve a new, detailed clinical study with novel acceptance criteria and performance reporting in the same way a PMA (Premarket Approval) might.
Therefore, most of the information you've requested is not available in this document. Here's what can be inferred or explicitly stated:
- Acceptance Criteria and Reported Device Performance: Not provided in this document. The letter only confirms "substantial equivalence."
- Sample size used for the test set and data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and qualifications: Not provided.
- Adjudication method: Not provided.
- MRMC comparative effectiveness study: Not applicable or not mentioned in this type of FDA clearance. This is an in vitro diagnostic device for detecting antibodies, not an AI-assisted diagnostic tool that would typically involve human readers.
- Standalone performance: The letter refers to the "REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit" as the device itself, implying it's a standalone test rather than an AI algorithm assisting a human reader. However, specific performance metrics are not given.
- Type of ground truth used: Not provided in this document. For an in vitro diagnostic device, this would typically involve a reference method or clinical diagnosis in a patient cohort.
- Sample size for the training set: Not applicable for this type of device submission as described. There is no mention of an "algorithm" or "training set" in the context of machine learning. This is a laboratory test kit.
- How the ground truth for the training set was established: Not applicable.
What the document does provide:
- Device Name: REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit
- Regulation Number/Name: 21 CFR 866.5660, Multiple autoantibodies immunological test system
- Regulatory Class: Class II
- Product Code: MID
- Indications for Use:
- An enzyme-linked immunosorbent assay (ELISA) for the determination of IgG and IgM 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).
To get the information you asked for, one would typically need to review the actual 510(k) submission summary or detailed study reports, 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 depiction of an eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
SFP 2 5 2002
8 Gaither Road ckville MD 20850
Ms. Nanci Dexter Director of Quality and Regulatory Affairs Corgenix 12061 Tejon Street Westminister. CO 80234
K022992 Re:
Trade/Device Name: REAADS Anti-Cardiolipin IgG/IgM Semi-Ouantitative 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
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/cdrb/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
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Indications for Use Statement
510(k) Number: K023192
Device Name: REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit Indications for Use:
An enzyme-linked immunosorbent assay (ELISA) for the determination of IgG and IgM 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
of Clinical Laboratory Devices 510(k) Number _
Prescription Use
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
§ 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).