K062770 · Abbott Diabetes Care, Inc. · NBW · Dec 14, 2006 · Clinical Chemistry
Device Facts
Record ID
K062770
Device Name
COPILOT HEALTH MANAGEMENT SYSTEM
Applicant
Abbott Diabetes Care, Inc.
Product Code
NBW · Clinical Chemistry
Decision Date
Dec 14, 2006
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.1345
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
The CoPilot™ Health Management System is intended for use in the home and clinical settings by people with diabetes and healthcare professionals as an aid in the review, analysis and evaluation of historical glucose test results in support of an effective diabetes management program.
Device Story
CoPilot Health Management System is PC-based software for diabetes data management. It ingests glucose data uploaded from FreeStyle and Precision Blood Glucose Monitoring Systems. Software functions include data entry, report generation, and synchronization. Used in home and clinical settings by patients, caregivers, and healthcare professionals. Users view glucose data via various graphs and statistics based on selectable date intervals, time segments, and target ranges. Output facilitates review and analysis of historical glucose results to support diabetes management decisions.
Clinical Evidence
No clinical data. Performance established through software, software QA, and system verification testing in accordance with FDA guidance for medical device software.
Technological Characteristics
PC-based software application operating on Microsoft Windows. Functions include data acquisition, storage, and reporting. Features data entry, report generation, and synchronization. Connectivity via data upload from blood glucose monitoring systems.
Indications for Use
Indicated for people with diabetes and healthcare professionals in home and clinical settings to aid in the review, analysis, and evaluation of historical glucose test results to support diabetes management programs.
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.
Submission Summary (Full Text)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850
JAN 16 2007
Ms. Mary Rose
Regulatory Affairs Supervisor
Abbott Diabetes Care, Inc.
1360 South Loop Road
Alameda, CA 94502
Re: k062770
Trade/Device Name: CoPilot Health Management System
Regulation Number: 21 CFR 862.1345
Regulation Name: Glucose test system
Regulatory Class: Class II
Product Code: NBW
Dated: September 14, 2006
Received: September 18, 2006
Dear Ms. Rose:
This letter corrects our substantially equivalent letter of December 14, 2006.
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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
