(14 days)
The REAADS Anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in patients with Systemic Lupus Erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).
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This document is a 510(k) premarket notification approval letter for an in vitro diagnostic device, not a study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement in a study.
The document approves the marketing of the device based on its substantial equivalence to a legally marketed predicate device, but it does not present the study data or acceptance criteria that led to this determination.
Here's a breakdown of why the requested information cannot be extracted from this document:
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A table of acceptance criteria and the reported device performance: This document only states the device name, intended use, and regulatory classification. It does not provide any performance metrics (e.g., sensitivity, specificity, accuracy) or the acceptance criteria used to evaluate these metrics.
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Sample sizes used for the test set and the data provenance: Not present.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
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Adjudication method: Not present.
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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: Not applicable, as this is not an AI-assisted diagnostic device. It's an in vitro diagnostic assay. Even if it were relevant, the document does not contain this information.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an in vitro diagnostic assay, not an algorithm-only device. Even if it were relevant, the document does not contain this information.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present.
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The sample size for the training set: Not present.
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How the ground truth for the training set was established: Not present.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three curved lines above them, resembling a bird in flight.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nanci Dexter Director, Quality Assurance and Regulatory Affairs Corgenix, Inc. 12061 Tejon Street Westminster, Colorado 80234
SEP 2 8 2001
Re: K013080
Trade/Device Name: REAADS IgG anti-B2GPI Test Kit Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: II Product Code: MSV Dated: September 11, 2001 Received: September 14, 2001
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 Sutman
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: K013080
Device Name: REAADS IgG anti-B2GI Test Kit Indications for Use:
The REAADS Anti-B2GPI Test Kit is an in viro diagnostic assay for the detection and secui-quantitation THE READS Anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in of T&O ank-DFOF I dinisources any thematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).
The REAADS IgG Anti-B2GPI Test Kit is intended to be used by clinical (hospital and reference) laboratories.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign/Date
ision Sign (Off) Division of Clinical Laboratory Devices
510(k) Number K013050
Prescription Use
Special 510(k): REAADS Anti-Beta 2 Glycoprotein I IgG 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).