(400 days)
ThymoStat™ is a qualitative plate ELISA for the detection of human anti-rabbit antibodies in human serum. The presence of human anti-rabbit antibodies has been associated with patients receiving injections of rabbit antibodies for therapeutic purposes.
Not Found
This document is primarily a letter from the FDA regarding 510(k) clearance for the ThymoStat™ ELISA device. It confirms FDA approval but does not contain detailed information about acceptance criteria or specific study methodologies, performance data, or ground truth establishment.
Therefore, I cannot provide the requested information from the given text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details about the experts for ground truth.
- Adjudication methods.
- Whether MRMC studies were done or effect sizes.
- Stand-alone performance.
- The type of ground truth used.
- Sample size for the training set or how its ground truth was established.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
SEP 3 0 1998
Hana B. Moran, Ph.D. Senior Vice President Regulatory Affairs and Quality Assurance Sangstat Medical Corporation 1505 Adams Drive Menlo Park, California 94025
Re : K973203/S2
Trade Name: ThymoStat™ ELISA for the Detection of Human IgG, M and A anti-Rabbit IgG Antibodies Regulatory Class: II Product Code: DAK Dated: August 31, 1998 Received: September 1, 1998
Dear Dr. Moran:
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 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 requlations 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 Regulation (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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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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 leqally 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 labelinq 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" (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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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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| 510(k) Number (if known): | #K973203 |
|---|---|
| Device Name: | ThymoStat™ ELISA for Detection of Human anti-Rabbit Antibodies |
| Indications for Use: | ThymoStat™ is a qualitative plate ELISA for the detection of human anti-rabbit antibodies in human serum.The presence of human anti-rabbit antibodies has been associated with patients receiving injections of rabbit |
antibodies for therapeutic purposes.
(Please Do Not Write Below This Line - Continue On Another Page If Needed Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Maples
Division Sign-Off
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K973203
Prescription Use
(Per 21 CFR §801.109)
Or
Over-The-Counter Use (Optional Format 1-2-96)
§ 866.5240 Complement components immunological test system.
(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).