AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA

K991890 · Cogent Diagnotics , Ltd. · MVJ · Aug 9, 1999 · Immunology

Device Facts

• Record ID: K991890
• Device Name: AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA
• Applicant: Cogent Diagnotics , Ltd.
• Product Code: MVJ · Immunology
• Decision Date: Aug 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to glomerular basement membrane(GBM) in human serum. The results of the anti-GBM assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-GBM antibodies including Goodpastures Syndrome. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. For in vitro diagnostic use only.

Device Story

Autostat™ Anti-GBM ELISA and HY•TEC Anti-GBM ELISA are in vitro diagnostic assays for detecting IgG autoantibodies to glomerular basement membrane (GBM) in human serum. The Autostat™ kit is a manual ELISA, while the HY•TEC kit is designed for use with the Hycor HY•TEC Automated EIA instrument. Both assays utilize enzyme-linked immunosorbent assay technology to provide semi-quantitative results. These results serve as one indicator within a multi-factorial diagnostic regime to assist clinicians in diagnosing conditions like Goodpasture's Syndrome. The devices are intended for professional use in clinical laboratory settings.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for semi-quantitative detection of IgG autoantibodies. The HY•TEC version is designed for integration with the Hycor HY•TEC Automated EIA instrument. In vitro diagnostic use.

Indications for Use

Indicated for the semi-quantitative determination of specific IgG autoantibodies to glomerular basement membrane (GBM) in human serum as an aid in the diagnosis of diseases associated with elevated anti-GBM levels, such as Goodpasture's Syndrome. For in vitro diagnostic use by prescription only.

Regulatory Classification

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).

Submission Summary (Full Text)

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Image /page/0/Picture/0 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" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

DEPARTMENT OF HEALTH & HUMAN SERVICES

AUG - 9 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, UK

Re: K991890

> Trade Name: Autostat™ Anti-GBM ELISA, HY•TEC Anti-GMB ELISA Regulatory Class: II Product Code: MVJ Dated: May 28, 1999 Received: June 3, 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 [phone].

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" (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 [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/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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## Indications for Use - Autostat™II Kit.

K991890

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to glomerular basement membrane(GBM) in human serum.

Uses:

:

The results of the anti-GBM assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-GBM antibodies including Goodpastures Syndrome.

Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.

For in vitro diagnostic use only.

Peter E. Madson

(Division Sign-Off) (Division Sign-On)
Division of Clinical Laboratory Devic 510(k) Number .

Prescription Use <

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## Indications for Use - Hy•Tec Kit.

K991890

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to GBM in human serum. This device is designed for use with the Hycor Hy•Tec Automated EIA instrument.

Uses:

The results of the anti-GBM assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-GBM antibodies including Goodpastures Syndrome.

Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.

For in vitro diagnostic use only.

Lrita E. Makim

(Division Sign-Off) Division of Clinical Laboratory Device 510(k) Number

Prescription Use