AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA

K990796 · Cogent Diagnotics , Ltd. · MOB · Apr 28, 1999 · Immunology

Device Facts

• Record ID: K990796
• Device Name: AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA
• Applicant: Cogent Diagnotics , Ltd.
• Product Code: MOB · Immunology
• Decision Date: Apr 28, 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 Pr 3 in human serum. The results of the anti-Pr 3 assay can be used as an aid in the diagnosis of autoimmune vasculiticles including Wegener's granulomatosis and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (c-ANCA). For in vitro diagnostic use only.

Device Story

In vitro diagnostic assay; utilizes enzyme-linked immunosorbent assay (ELISA) method to detect IgG autoantibodies to Pr 3 in human serum samples. Autostat™ II is a manual or semi-automated kit; Hy-Tec Anti-PR3 is designed for use with the Hycor Hy-Tec Automated EIA instrument. Operated by laboratory personnel in clinical settings. Output provides semi-quantitative antibody levels; assists clinicians in diagnosing autoimmune vasculitides and Wegener's granulomatosis. Results support clinical decision-making regarding autoimmune disease management.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for IgG autoantibody detection. Autostat II is a kit format; Hy-Tec version is designed for use with the Hycor Hy-Tec Automated EIA instrument. In vitro diagnostic use.

Indications for Use

Indicated for semi-quantitative determination of IgG autoantibodies to Pr 3 in human serum to aid in diagnosis of autoimmune vasculitides, including Wegener's granulomatosis and conditions associated with elevated c-ANCA.

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).

Reference Devices

• Hycor Hy-Tec Automated EIA instrument

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 1999

Ms. Danielle M. Knight Quality Manager Cogent Diagnostics Limited Pentlands Science Park Bush Loan Penicuik EH26 OPL United Kingdom

Re: K990796

> Trade Name: Cogent Autostat™ II Anti-PR3 ELISA Hycor Hy-Tec Anti-PR3 ELISA Regulatory Class: II Product Code: MOB Dated: February 24, 1999 Received: March 10, 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 (OS) 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 [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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): K998796

Device Name: Autostat II Anti-PR3 (cANCA)

Indications For Use:

## Indications for Use - Autostat™I Kit.

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to Pr 3 in human serum.

Uses:

The results of the anti-Pr 3 assay can be used as an aid in the diagnosis of autoimmune vasculiticles including Wegener's granulomatosis and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (c-ANCA).

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)

Arthur E. Hakim

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K907

Prescription Use i/
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K990796

Device Name: Hy-Tec Anti-PR3 (CANCA)

## Indications For Use:

## Indications for Use - Hy·Tec Kit.

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to Pr 3 in human serum. This device is designed for use with the Hycor Hy. Tec Automated EIA instrument.

Uses:

The results of the anti-Pr 3 assay can be used as an aid in the diagnosis of auto-immune vasculitides including Wegener's granulomatosis and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (c-ANCA).

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)

Peter E. Mclain

(Division Sign-Off)
Division of Clinical Laboratory Devices K990794
510(k) Number

**Prescription Use** √
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)