KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT

K051061 · Kronus Market Development Associates, Inc. · NWG · Nov 4, 2005 · Immunology

Device Facts

• Record ID: K051061
• Device Name: KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT
• Applicant: Kronus Market Development Associates, Inc.
• Product Code: NWG · Immunology
• Decision Date: Nov 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The KRONUS GADAb RIA Assay Kit is for the semi-quantitative determination of glutamic acid decarboxylase antibody in human serum. The KRONUS GADAb RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).

Device Story

The KRONUS GADAb RIA Assay Kit is an in vitro diagnostic test for semi-quantitative detection of glutamic acid decarboxylase (GAD) autoantibodies in human serum. The device uses a radioimmunoassay (RIA) principle; patient serum is incubated with human recombinant I125-labeled GAD65 tracer. GAD antibodies present in the sample bind to the tracer. Protein A is added to precipitate the antigen-antibody complexes. After centrifugation and decanting, the radioactivity in the pellet is measured using a gamma counter. The amount of radioactivity is directly proportional to the concentration of GAD antibodies in the sample. Results are determined by interpolating from a calibration curve. The assay is performed in a clinical laboratory setting by trained personnel. The output provides clinicians with a semi-quantitative value to assist in the diagnosis of Type I diabetes mellitus.

Clinical Evidence

Clinical performance evaluated in 401 subjects. Sensitivity for Type I diabetes was 69.3% (106/153; 95% CI: 62-76%). Specificity in non-diabetic autoimmune patients and healthy normals was 98.4% (244/248; 95% CI: 96-100%). Overall agreement was 87.3%. Supporting literature reported clinical sensitivity of 64-83% and specificity of 98-100%. Analytical precision (intra-assay CV 3.6-6.7%; inter-assay CV 4.7-10.8%) and interference testing (hemoglobin, bilirubin, lipids) were also provided.

Technological Characteristics

Radioimmunoassay (RIA) using human recombinant I125-labeled GAD65 tracer. Components include lyophilized tracer, assay buffer, calibrators, and Protein A precipitating reagent. Requires external gamma counter for detection. Measuring range 0-300 U/mL; cut-off >1 U/mL. Manual liquid-phase binding assay.

Indications for Use

Indicated for use as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes) in patients suspected of having the condition.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle. The text is in all capital letters and is arranged in a circular fashion to match the shape of the circle.

NOV - 4 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Heather Viele Director of Technical Affairs KRONUS, Inc. Boise Research Center 12554 West Bridger Street Suite 108 Boise, ID 83713

Rc: k051061

Trade/Device Name: KRONUS Glutamic Acid Decarboxylase (GADAb) RIA Assay Kit Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: NWG Dated: September 19, 2005 Received: September 20, 2005

Dear Ms. Viele:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR). Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

This letter will allow you to begin marketing your device as described in your Section 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.

{1}------------------------------------------------

Page 2 -

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Robert Beckerh

Robert L. Becker, Jr., MD, PH.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## K051061 KRONUS Glutamic Acid Decarboxylase Antibody (GADAb) RIA

## Indications for Use

510(k) Number (if known): K051061

## Device Name:

KRONUS Glutamic Acid Decarboxylase (GADAb) RIA Assay Kit

## Indications for Use Statement:

The KRONUS GADAb RIA Assay Kit is for the semi-quantitative determination of glutamic acid decarboxylase antibody in human serum. The KRONUS GADAb RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).

(Please Do Not Write Below This Line -- Continue On another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Pursuant to 21 CFR 801.109)

OR

Over-the-counter Use

Josephine Bautista

Division Sign Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(K)_KO5106