(14 days)
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Not Found
No
The summary describes an in vitro diagnostic assay for detecting antibodies, which is a biochemical test and does not mention any computational or algorithmic components indicative of AI/ML.
No
Explanation: This device is an in vitro diagnostic assay used to detect antibodies for assessing the risk of thrombosis. It is not designed to treat, cure, mitigate, or prevent disease.
Yes
The "Intended Use / Indications for Use" states that the device is an "in vitro diagnostic assay" and is used as "an aid for assessing the risk of thrombosis." This clearly indicates its role in diagnosing or aiding in the diagnosis of a medical condition.
No
The device is described as an "in vitro diagnostic assay" and a "Test Kit," which strongly implies the presence of physical reagents and potentially hardware components for performing the assay, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The REAADS IgA anti-B2GPI Test Kit is an in vitro diagnostic assay..."
This statement directly identifies the device as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The REAADS IgA anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semiquantitation of IgA anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).
Product codes
MSV
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
The REAADS IgA anti-B2GPI Test Kit is intended to be used by clinical (hospital and reference) laboratories.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 stylized eagle with three human profiles incorporated into its body. The eagle is facing right, and the profiles are arranged vertically, suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
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: K013079
Trade/Device Name: REAADS IgA 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 wo nave reviews of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreat 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, de nees mat have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Four may , are severy interest 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 may or backed to be 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 r rease of a 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 noutication. The I Drivinating of station 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 IT you desire specific daily of your ostic devices), please contact the Office of Compliance at additionally 607.10 for in in in many of the promotion and advertising of your device, (201) 594-1568 - 11 - 15 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 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 Information on your responsibilities with er answer Assistance at its toll-free number (800) 638-2041 or 1901) 443-6597 or at its internet address "http://www.fda.gov/cdrl/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
2
Indications for Use Statement
510(k) Number: K013079
Device Name: REAADS IgA anti-B2GI Test Kit Indications for Use:
The REAADS IgA anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semiquantitation of IgA anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).
The REAADS IgA anti-B2GPI Test Kit is intended to be used by clinical (hospital and reference) laboratories.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign on)
(Division Sign Off Division of Clinical Laboratory Devices
510(k) Number K013079
Prescription Use √
Special 510(k): REAADS Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit