ACON ON CALL DIABETES MANAGEMENT SOFTWARE

K131469 · ACON Laboratories, Inc. · NBW · Jan 6, 2014 · Clinical Chemistry

Device Facts

• Record ID: K131469
• Device Name: ACON ON CALL DIABETES MANAGEMENT SOFTWARE
• Applicant: ACON Laboratories, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 6, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The On Call® Diabetes Management Software is an optional software accessory to be used with the compatible On Call Glucose Meters, such as On-Call Plus glucose meter, On-Call Chosen glucose meter, On-Call Vivid glucose meter and On-Call Express glucose meter for transferring data to a computer and organizing it in tables and graphs to be used at home and by health care professionals. The software does not recommend any medical treatment or medication dosage level.

Device Story

On Call Diabetes Management Software functions as an optional accessory for On Call series glucose meters (Plus, Chosen, Vivid, Express). Device facilitates data transfer from glucose meters to a computer via cable connection. Software organizes blood glucose readings into tables and graphs for review by patients at home or healthcare professionals in clinical settings. Output provides visual representation of historical glucose data to assist in monitoring trends. Software does not provide medical advice, treatment recommendations, or dosage calculations. Intended to support diabetes management through data visualization.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based data management system; operates on personal computers; connects to glucose meters via data cable; provides data visualization (tables/graphs); does not perform diagnostic analysis or treatment recommendations.

Indications for Use

Indicated for use by patients and healthcare professionals to transfer, organize, and display glucose data from compatible On Call glucose meters in tables and graphs. No specific age or disease state restrictions; not for medical treatment or dosage recommendations.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• On Call Diabetes Management Software (K113566)

Submission Summary (Full Text)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 6, 2014

ACON LABORATORIES, INC. QIYI XIE, M.D. SENIOR STAFF, REGULATORY AFFAIRS 10125 MESA RIM ROAD SAN DIEGO CA 92121

Re: K131469

Trade/Device Name: Acon On Call Diabetes Management Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, JOP Dated: December 05, 2013 Received: December 09, 2013

#### Dear Dr. Xie:

·

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 Parts 801 and 809); medical device reporting (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 Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias -S

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

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Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

k131469

Device Name

On Call® Diabetes Management Software

Indications for Use (Describe)

The On Call® Diabetes Management Software is an optional software accessory to be used with the compatible On Call Glucose Meters, such as On-Call Plus glucose meter, On-Call Chosen glucose meter, On-Call Vivid glucose meter and On-Call Express glucose meter for transferring data to a computer and organizing it in tables and graphs to be used at home and by health care professionals. The software does not recommend any medical treatment or medication dosage level.

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

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

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