(14 days)
Not Found
Not Found
No
The summary describes a laboratory test kit for detecting antibodies, which is a standard in vitro diagnostic method and does not mention any computational analysis or algorithms indicative of AI/ML.
No
The device is described as an "in vitro diagnostic assay" which indicates it is used for diagnostic purposes, not for treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device 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 components for laboratory testing. It is not described as 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 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 detection and semi-quantitation of IgG and IgM anti-phosphatidylserine antibodies in human serum or plasma in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).
Product codes
MID
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The REAADS Anti-Phosphatidylserine Semi-Quantitative 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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows a logo for Man Services. The logo is a circle with the words "MAN SERVICES" written around the top and bottom. Inside the circle is a stylized image of three lines that resemble a bird in flight. The lines are black and the background is white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 9 3 2003
Ms. Nanci Dexter Director of Quality and Regulatory Affairs Corgenix 12061 Tejon Street Westminister, CO 80234
K024196 Re:
Trade/Device Name: REAADS Anti-Phosphatidy|serine IgG/IgM Semi-Quantitative Test Kit Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test sysstem Regulatory Class: Class II Product Code: MID Dated: December 19, 2002 Received: December 20, 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
1
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number: K024196
Device Name: REAADS Anti- Phosphatidylserine IgG/IgM Semi-Quantitative Test Kit 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-phosphatidyIserine 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)
Sinita Y. Michine M.D.
FOR T. BAUTISTA
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_ KO24 196
Prescription Use (Per 21 CFR 801.109) Over-The-CounterUse
(Optional Format 1-2-96)
Special 510(k): REAADS anti-PhosphatidyIserine IgG/M Semi-Quantitative Test Kit
OR
29