KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT

K073590 · Kronus Market Development Associates, Inc. · OIF · Apr 10, 2008 · Immunology

Device Facts

• Record ID: K073590
• Device Name: KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT
• Applicant: Kronus Market Development Associates, Inc.
• Product Code: OIF · Immunology
• Decision Date: Apr 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The KRONUS IA-2 Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to tyrosine phosphatase (IA-2) in human serum. The KRONUS IA-2 Autoantibody RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).

Device Story

The KRONUS IA-2 Autoantibody RIA Assay Kit is an in vitro diagnostic test for human serum. It utilizes a radioimmunoassay (RIA) principle to detect autoantibodies to tyrosine phosphatase (IA-2). Patient serum is incubated with human recombinant I¹²⁵-labeled IA-2 tracer; antibodies bind to the tracer. Protein A is added to precipitate the antigen-antibody complexes. After centrifugation and washing, the radioactivity in the pellet is measured using a gamma counter. The amount of radioactivity is directly proportional to the IA-2 autoantibody concentration. Results are determined by interpolating from a standard curve generated by five calibrators. The assay is performed in a laboratory setting by trained personnel. The output provides a semi-quantitative value (U/mL) used by clinicians to support the diagnosis of Type I diabetes mellitus. The device benefits patients by providing an immunological marker to assist in differentiating autoimmune-mediated diabetes from other forms.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on performance characteristics of the RIA assay.

Technological Characteristics

Radioimmunoassay (RIA) using human recombinant I¹²⁵-labeled IA-2 tracer. Components include lyophilized tracer, assay buffer, Protein A reagent, and calibrators (0.0-50 U/mL). Requires a gamma radiation counter and refrigerated centrifuge (1500 x g). Semi-quantitative measurement via interpolation from a semi-log standard curve. Shelf-life of 8 weeks at 2-8°C.

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. No specific age or gender restrictions are noted.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

APR 1 0 2008

Re: k073590

Trade/Device Name: KRONUS IA-2 Autoantibody RIA Assay Kit Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test systems Regulatory Class: Class II Product Code: OIF Dated: March 24, 2008 Received: March 25, 2008

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

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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,

Paler H. Boter

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

Enclosure

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Indications for Use

K073590 510(k) Number (if known):

Device Name:

KRONUS IA-2 Autoantibody RIA Assay Kit

Indications for Use Statement:

The KRONUS IA-2 Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to tyrosine phosphatase (1A-2) in human serum. The KRONUS IA-2 Autoantibody RIA Assay is useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X OR (Pursuant to 21 CFR 801.109)

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Over-the-counter Use

m chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K073590