KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

K171731 · Kronus, Inc. · OIF · Jan 19, 2018 · Immunology

Device Facts

• Record ID: K171731
• Device Name: KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
• Applicant: Kronus, Inc.
• Product Code: OIF · Immunology
• Decision Date: Jan 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is for the quantitative determination of antibodies to Islet Antigen-2 (IA-2) in human serum. The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.

Device Story

The KRONUS IA-2Ab ELISA Kit is an in vitro diagnostic assay used to measure autoantibodies against Islet Antigen-2 in human serum. The device utilizes an enzyme-linked immunosorbent assay (ELISA) format. It is intended for use by laboratory professionals in clinical settings to assist in the diagnosis of Type 1 diabetes mellitus. The test results are provided to clinicians, who interpret them alongside other clinical and laboratory findings to support a diagnosis. The device aids in identifying autoimmune-mediated diabetes, potentially facilitating earlier clinical intervention and management for patients.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on technological and performance characteristics compared to the predicate device.

Technological Characteristics

Quantitative ELISA; uses rhIA-2 coated stripwells and biotinylated rhIA-2. Detection via streptavidin-peroxidase and TMB substrate. Requires microtiter plate reader (450 nm) and ELISA plate shaker (500 shakes/min). Traceable to NIBSC 97/550. Measuring range: 5.4–350 U/mL. Cut-off: 7.5 U/mL. Reagents include buffers, stabilizers, and sulfuric acid stop solution.

Indications for Use

Indicated for quantitative determination of IA-2 autoantibodies in human serum as an aid in diagnosing Type 1 diabetes mellitus. For use by laboratory professionals in clinical settings. Prescription use 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).

Predicate Devices

• KRONUS IA-2Ab RIA Assay Kit (k073590)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 19, 2018

Kronus, Inc. Brian Deis Quality Control and Regulatory Compliance Manager 170 S. Seneca Springs Way Suite 105 Star, ID 83669

Re: K171731

Trade/Device Name: KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: II Product Code: OIF Dated: December 11, 2017 Received: December 13, 2017

Dear Brian Deis:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

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Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K171731

Device Name KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

#### Indications for Use (Describe)

The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is for the quantitative determination of antibodies to Islet Antigen-2 (IA-2) in human serum. The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
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| <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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