KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT

K070183 · Kronus Market Development Associates, Inc. · OCN · Jul 13, 2007 · Immunology

Device Facts

• Record ID: K070183
• Device Name: KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT
• Applicant: Kronus Market Development Associates, Inc.
• Product Code: OCN · Immunology
• Decision Date: Jul 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The KRONUS Insulin Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to insulin in human serum. The KRONUS Insulin Autoantibody RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.

Device Story

The KRONUS Insulin Autoantibody (IAA) RIA Assay Kit is an in vitro diagnostic test used to detect insulin autoantibodies in human serum samples. It utilizes a radioimmunoassay (RIA) principle to measure the presence of these antibodies. The assay is intended for use by laboratory professionals to assist in the clinical diagnosis of Type I diabetes mellitus in patients who have not yet undergone insulin therapy. The test provides a semi-quantitative result, which clinicians use alongside other clinical findings to support a diagnosis of autoimmune-mediated diabetes. By identifying the presence of insulin autoantibodies, the device helps differentiate Type I diabetes from other forms of the disease, potentially guiding early clinical management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radioimmunoassay (RIA) platform. Components: lyophilized I125-labeled human recombinant insulin tracer, assay buffer, 5 calibrators (0.0-50 U/mL), goat anti-human IgG precipitating reagent, and control sera. Requires refrigerated centrifuge (1500 x g) and gamma counter. Measurement range: 0.40 to 50 U/mL. Shelf-life: 8 weeks at 2-8°C.

Indications for Use

Indicated for the semi-quantitative determination of insulin autoantibodies in human serum to aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.

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/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. The eagle is facing to the right, and the text is arranged in a clockwise direction around the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

KRONUS Market Development Associates, Inc. c/o Ms. Heather Viele Director of Technical Affairs 12554 West Bridger Street, Suite 108 Boise, ID 83713

JUL 1 3 2007

Re: k070183

Trade/Device Name: KRONUS Insulin Autoantibody RIA Kit Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: Class II Product Code: OCN Dated: May 31, 2007 Received: June 1, 2007

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 does 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 Part 801); 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

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

Page 2 –

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 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 H. Beckerf

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

Enclosure

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

## Indications for Use

K070183 510(k) Number (if known): Fo be assigned by FDA

## Device Name:

KRONUS Insulin Autoantibody (IAA) RIA Assay Kit

## Indications for Use Statement: .

The KRONUS Insulin Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to insulin in human serum. The KRONUS Insulin Autoantibody RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.

(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

Mana m Chan

Division Sign-Off

Office of In Vitro Diag Device Eyaluation and S

510(k) Ko70/63

KRONUS IAA RIA Assay Kit Premarket Notification January, 2007