AUTOSTAT II RHEUMATOID FACTOR IGM ELISA

K994338 · Cogent Diagnotics , Ltd. · DHR · Feb 3, 2000 · Immunology

Device Facts

• Record ID: K994338
• Device Name: AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
• Applicant: Cogent Diagnotics , Ltd.
• Product Code: DHR · Immunology
• Decision Date: Feb 3, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

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

Device Story

Autostat™ II Rheumatoid Factor IgM ELISA is an enzyme-linked immunosorbent assay (ELISA) for detecting IgM rheumatoid factor antibodies in human serum. The device is intended for use as an aid in diagnosing rheumatoid arthritis. It is designed for use on the Dynatech automated EIA instrument. Healthcare providers use the assay results in conjunction with other clinical and laboratory findings to support a diagnosis. The test provides semi-quantitative data, which serves as one indicator within a multifactorial diagnostic regime.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for semi-quantitative detection of IgM rheumatoid factor. Designed for use on the Dynatech automated EIA instrument. In vitro diagnostic device.

Indications for Use

Indicated for the semi-quantitative determination of specific IgM rheumatoid factor (RF) antibodies in human serum as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations.

Regulatory Classification

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.

Submission Summary (Full Text)

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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)

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(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)