(13 days)
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No
The document describes an in vitro diagnostic assay kit and does not mention any AI or ML components or functionalities.
No
The device is described as an "in vitro diagnostic assay" intended for the detection and semi-quantitation of antibodies for diagnostic purposes, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the kit is an "in vitro diagnostic assay".
No
The device is an in vitro diagnostic assay kit, which is a physical product containing reagents and other materials for laboratory testing, not a software-only device.
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 statement directly identifies the device as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The REAADS Anti-Phosphatidylserine Semi-Quantitative Test Kit is an in vitro diagnostic assay for the I ho Keria and semi-quantitation of IgA anti-phosphatidylserine antibodies in human serum or plasma in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).
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).
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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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human figures in profile, stacked on top of each other, with flowing lines suggesting movement or connection.
SEP 2 0 2001
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
Re: K013018
Trade Name: REAADS Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit Regulation Number: 866.5660 Regulatory Class: II Product Code: MID Dated: September 5, 2001 Received: September 7, 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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:________________________________________________________________________________________________________________________________________________________________
Device Name: REAADS Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit
Indications for Use:
The REAADS Anti-Phosphatidylserine Semi-Quantitative Test Kit is an in vitro diagnostic assay for the I ho Keria and semi-quantitation of IgA anti-phosphatidylserine antibodies in human serum or plasma in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).
The REAADS Anti-Phosphatidylserine Semi-Quantitative 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)
Susan S. Altare
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K0/3018