(14 days)
The REAADS Anti-Phosphatidylserine Semi-Quantitative Test Kit is an in vitro diagnostic assay for the 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).
REAADS Anti-Phosphatidylserine Semi-Quantitative Test Kit
The provided document is a 510(k) clearance letter from the FDA for the REAADS® anti-phosphatidylserine IgG/IgM Semi-quantitative Test Kit. It states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain the detailed information requested regarding:
- Table of acceptance criteria and reported device performance.
- Sample size and data provenance for the test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone (algorithm-only) performance results.
- Type of ground truth used.
- Training set sample size.
- How ground truth for the training set was established.
The document is a regulatory approval, not a technical study report. To obtain the requested information, one would typically need to refer to the 510(k) submission summary, the device's Instructions for Use (IFU), or published clinical validation studies, none of which are included in this excerpt.
Therefore, I cannot provide the requested information from the given text.
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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)
(Division C Off)
(Division Div
Division
510(k) No
§ 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).