(63 days)
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG rheumatoid factor (RF) antibodies in human serum.
Uses:
The results of the RF IgG assay can be used as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations.
Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
The assay may be used on the Hycor Hy•Tec Automated EIA instrument.
For in vitro diagnostic use only.
Not Found
The provided text is a clearance letter from the FDA for the Autostat™I Rheumatoid Factor IgG ELISA device (K993304). It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or details about the study that proves the device meets those criteria, based on the information provided. The document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines the regulatory framework for its marketing.
To answer your request, I would need access to the original 510(k) submission document (K993304) itself, or a summary of its performance data.
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DEC - 6 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Danielle M. Knight Quality Manager Cogent Diagnostics Ltd. Pentlands Science Park Bush Loan, Penicuik Midlothian EH26 0PL Scotland, United Kingdom
Re: K993304
Trade Name: Autostat™I Rheumatoid Factor IgG ELISA Regulatory Class: II Product Code: DHR Dated: September 30, 1999 Received: October 4, 1999
Dear Ms. Knight:
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 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 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.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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" (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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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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| 10(k) Number (if known): | K993304 |
|---|---|
| Device Name: | Autostat II Rheumatoid |
Eutos Tac ELISA## Indications For Use:
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG rheumatoid factor (RF) antibodies in human serum.
Uses:
The results of the RF IgG assay can be used as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations.
Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
The assay may be used on the Hycor Hy•Tec Automated EIA instrument.
For in vitro diagnostic use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kilu E. Madan
(Division Sign-On
Division of Clinical Laboratory Devices K93304
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).