(14 days)
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No
The document describes a standard in vitro diagnostic assay kit and contains no mention of AI, ML, or related concepts.
No
The device is described as an "in vitro diagnostic assay" which is used for quantitation of antibodies in human serum for diagnostic purposes of disorders, not for therapeutic intervention.
Yes
The "Intended Use / Indications for Use" states that the kit is an "in vitro diagnostic assay".
No
The device is described as an "in vitro diagnostic assay" and a "Test Kit," which strongly suggests it includes physical reagents and components, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The REAADS Anti-Phosphatidylserine Semi-Quantitative Test Kit is an in vitro diagnostic assay..." This directly identifies the device as an IVD.
N/A
Intended Use / Indications for Use
The REAADS Anti-Phosphatidylserine Semi-Quantitative Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG and IgM anti-phosphatidylserine antibodies in human serum or plasma. Measurement of anti-phosphatidylserine antibodies is used as an aid in the diagnosis of antiphospholipid syndrome in conjunction with other laboratory and clinical findings. The REAADS Anti-Phosphatidylserine Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
Product codes
MID
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
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/1 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 symbol resembling an eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 3 2001
Ms. Nanci Dexter Director of Quality and Regulatory Affairs Corgenix, Inc. 12061 Teion Street Westminster, CO 80234
Re: K012567
Trade/Device Name: REAADS® anti-phosphatidy|serine IgG/IgM Semi-quantitative Test Kit Regulation Number: 21 CFR 866.5660 Regulatory Class: Class II Product Code: MID Dated: August 8, 2001 Received: August 9, 2001
Dear Ms. Dexter:
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 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.
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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 nredicate 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 1 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: K012567
Device Name: REAADS Anti-Phosphatidylserine Semi-Quantitative Test Kit
Indications for Use:
The REAADS Anti-Phosphatidylserine Semi-Quantitative Test Kit is an in vitro diagnostic assay for the THE KEADS Anti-quantitation of IgG and IgM anti-phosphatidylserine antibodies in human serum or delection and sem-quantiation of 180 and 125 and procession in the disorders (antiphospholipid syndrome).
The REAADS Anti-Phosphatidylserine Semi-Quantitative 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)
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Division
510(k) No