(42 days)
ENZAME LINKED IMMUNDSOKERAT ASSIM METHOD FOR THE SOMI - QUATITATUE DEFERENTIAN ATTON OF SFECIFIC IGM RHEUMATOLD FACTOR (RF) ANTIES DIES IN HUMAN SEBENA. USES: THE RESULTS OF THE REIGM ASSAY CAN BE USED AS AN AID IN THE DIRENCES & RHERMATORD ARTHRITIS CRA) WHEN SUPPORTED BY OTHER CABORATORY AND CUMCAL INVESTIGATIONS . LEVELS OF THESE AUTOANTIES ARE ONE ONE MINICATION IN A MUTIFACTORIAL DIAGNOSTIC GIME. THE ASSAY MAT BE USED ON THE HAUSE HYOTEC AUTOMATED EIA INSTRUMENT. FOR IN UTRO DIAGNOSIAC USE CAULY
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them, as requested. The document is an FDA 510(k) clearance letter for the "Autostat™ II Rheumatoid Factor IgM ELISA" device, indicating that it has been deemed substantially equivalent to a legally marketed predicate device.
The letter does not include:
- A table of acceptance criteria or reported device performance.
- Details about the sample size, data provenance, number of experts, adjudication methods for ground truth, or qualifications of experts.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
- Details about standalone algorithm performance studies.
- The type of ground truth used for any studies.
- Information about the training set size or how its ground truth was established.
The document only states the device's trade name, regulatory class, product code, and its intended use: "ENZYME LINKED IMMUNOSORBENT ASSAY METHOD FOR THE SEMI-QUANTITATIVE DETERMINATION OF SPECIFIC IGM RHEUMATOID FACTOR (RF) ANTIBODIES IN HUMAN SERA. USES: THE RESULTS OF THE RF IGM 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 INDICATION IN A MULTIFACTORIAL DIAGNOSTIC SCHEME. THE ASSAY MAY BE USED ON THE HAAKE HYPOTEC AUTOMATED EIA INSTRUMENT. FOR IN VITRO DIAGNOSTIC USE ONLY."
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle's head and neck, depicted with three curved lines.
Food and Drug Administratic 2098 Gaither Road Rockville MD 20850
3 2000 FEB
Ms. Danielle M. Knight Quality Manager Cogent Diagnostics Limited Pentlands Science Park Bush Loan, Penicuik Midlothian EH26 OPL Scotland, UK
Re: K994338
Trade Name: Autostat™ II Rheumatoid Factor IgM ELISA Regulatory Class: II Product Code: DHR Dated: December 16, 1999 Received: December 23, 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.
{1}------------------------------------------------
Page 2
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" (21CFR 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 Autman
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
{2}------------------------------------------------
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K 994338
Device Name: AUTOSTAT II RIHAMAJO D
FACTOR KM GUSA
Indications For Usc:
ENZAME LINKED IMMUNDSOKERAT ASSIM METHOD FOR THE SOMI - QUATITATUE DEFERENTIAN ATTON OF SFECIFIC IGM RHEUMATOLD FACTOR (RF) ANTIES DIES IN HUMAN SEBENA.
USES: THE RESULTS OF THE REIGM ASSAY CAN BE USED AS AN AID IN THE DIRENCES & RHERMATORD ARTHRITIS CRA) WHEN SUPPORTED BY OTHER CABORATORY AND CUMCAL INVESTIGATIONS .
LEVELS OF THESE AUTOANTIES ARE ONE ONE MINICATION IN A MUTIFACTORIAL DIAGNOSTIC GIME. THE ASSAY MAT BE USED ON THE HAUSE HYOTEC AUTOMATED EIA INSTRUMENT. FOR IN UTRO DIAGNOSIAC USE CAULY
(PLEASE DU NOT WILL BELLIW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRII, Office of Device Evaluation (ODE)
(Division Sion-Offi
Ma
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. tatory Devices K994338
Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter Usc
(Optional Formal 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).