(161 days)
Not Found
No
The device description details a standard ELISA assay with spectrophotometric reading and a single point calibrator. There is no mention of AI/ML in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic assay used for detection and semi-quantitation, which aids in assessing the risk of thrombosis. It does not provide therapy or treatment.
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 a microwell plate, 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 IgA anti-B2GPI Test Kit is an in vitro diagnostic assay..."
This statement directly identifies the device as an in vitro diagnostic. The description of the device and its use in testing human serum samples to aid in assessing the risk of thrombosis further supports this classification.
N/A
Intended Use / Indications for Use
The REAADS IgA anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of I he real and in the man serum 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
The REAADS IgA anti-B2GPI Test Kit is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with purified human Beta-2 Glycoprotein I. Incubation allows the anti-B2GPI antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human IgA, labeled with horseradish peroxidase (HRP), are added forming complexes with the B2GPI bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethlybenzidine (TMB) and hydrogen peroxide (H2Q2) as the chromogenic substrate. The intensity of the color generated is proportional to the serum concentration of anti-B2GPI antibodies. Optical density is read spectrophotometrically at 450nm. The total incubation time (at room temperature) of the assay is 40 minutes. The assay makes use of a single point calibrator to measure the amount of IgA anti-B2GPI antibodies in patient samples.
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 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
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)
Performance indicates that REAADS anti-Beta-2 Glycoprotein I and the QUANTA Lite IgA anti B2GPI ELISA are equivalent. In-house studies indicate a sensitivity of 25% for unselected SLE patients and 78% for primary APS patient samples. The coefficient of correlation for individual values in unselected SLE patients showed a good correlation of 0.721 with a P-value of 0.015 (by single factor ANOVA), indicating the results by the two methods are statistically similar. Although differences between the assays are observed, in general, the performance characteristics are comparable. These results are also in compliance with those in published literature for antiphospholipid syndrome detection. The clinical studies performed demonstrate that the REAADS IgA anti-B2GPI Test Kit is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
sensitivity of 25% for unselected SLE patients and 78% for primary APS patient samples.
coefficient of correlation for individual values in unselected SLE patients showed a good correlation of 0.721 with a P-value of 0.015 (by single factor ANOVA)
Predicate Device(s)
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
DEC 22 1998
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SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS REAADS IgA anti-B2GPI Test Kit December 01, 1998
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The REAADS IgA anti-B2GPI Test Kit is compared to a legally marketed predicate device and a substantial equivalence claim made. The predicate device is QUANTA Lite IgA anti B2GPI ELISA (K973006) currently manufactured and marketed by INOVA Diagnostics, Inc., San Diego, California.
The REAADS IgA anti-B2GPI Test Kit is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with purified human Beta-2 Glycoprotein I. Incubation allows the anti-B2GPI antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human IgA, labeled with horseradish peroxidase (HRP), are added forming complexes with the B2GPI bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethlybenzidine (TMB) and hydrogen peroxide (H2Q2) as the chromogenic substrate. The intensity of the color generated is proportional to the serum concentration of anti-B2GPI antibodies. Optical density is read spectrophotometrically at 450nm. The total incubation time (at room temperature) of the assay is 40 minutes. The assay makes use of a single point calibrator to measure the amount of IgA anti-B2GPI antibodies in patient samples.
The intended use of the device is for the detection and semi-quantitation of IgA anti-B2GPI antibodies in human serum as an aid for assessing the risk of thrombosis in individuals with systemic lupus ervthematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). Most autoimmune antiphospholipid antibodies require a serum cofactor (B2GPI) for optimal binding. It has been shown that many anti-phospholipid antibodies may react to a neoepitope formed on the B2GPI molecule by the interaction between the phospholipid and B2GPI. In addition, it has been reported that anti-B2GPI antibodies are more specific for thrombosis than antibodies detected by classic antiphospholipid ELISAs. Testing for anti-B2GPI antibodies in the clinical laboratory by ELISA is becoming increasingly valuable and provides additional clinically relevant results to assess patients for the antiphospholipid syndrome and/or the risk of thrombosis.
Performance indicates that REAADS anti-Beta-2 Glycoprotein I and the QUANTA Lite IgA anti B2GPI ELISA are equivalent. In-house studies indicate a sensitivity of 25% for unselected SLE patients and 78% for primary APS patient samples. The coefficient of correlation for individual values in unselected SLE patients showed a good correlation of 0.721 with a P-value of 0.015 (by single factor ANOVA), indicating the results by the two methods are statistically similar. Although differences between the assays are observed, in general, the performance characteristics are comparable. These results are also in compliance with those in published literature for antiphospholipid syndrome detection. The clinical studies performed demonstrate that the REAADS IgA anti-B2GPI Test Kit is safe and effective.
Maurice Austin
/2-i/-4/y
Nanci Dexter Director, Ouality Assurance and Regulatory Affairs
Date
12061 TEJON STREET · WESTMINSTER, CO · 80234 U.S.A. PHONE: 303.457.4345 FAX: 303.457.4519 www.corgenix.com
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 22 1998
Ms. Nanci Dexter Director of Quality and Regulatory Affairs CORGENIX, INC. 12061 Tejon St. Westminister, CO 80234
Re: K982434 Trade Name: REAADS IgA anti-B2GPI Test Kit Requlatory Class: II Product Code: MSV Dated: December 1, 1998 Received: December 2, 1998
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 (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). 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 aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
Indications for Use Statement
510(k) Number: K982434
Device Name: REAADS IgA anti-B2GPI Test Kit
Indications for Use:
The REAADS IgA anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of I he real and in the man serum 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)
Peter E. Malm
Prescription Use