The PC care Blood Glucose Data Management Software is PC-based software intended for use in the home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for an effective diabetes management program. The PC care™ Blood Glucose Data Management Software connects to an i-SENS blood glucose meter, which comes with a PC care USB cable. The PC care " Blood Glucose Data Management Software allows the user to download Blood glucose readings automatically from the meter to the PC.

Device Description

The PC care™ Blood Glucose Data Management Software is an optional data management software for use only with the i-SENS Blood Glucose Meters. The PC care™ Blood Glucose Data Management Software allows the transfer of data from the i-SENS Blood Glucose Meters to a personal computer for enhanced data management using graphic displays and analysis tools of the device. Various graphic analysis tools in this software help users of i-SENS BGM system easily analyze the trends and changes in their blood glucose.

AI/ML Overview

The provided text describes the i-SENS PC care™ Blood Glucose Data Management Software, which is an accessory application for glucose meters. The submission is a 510(k) for substantial equivalence to a predicate device, the Zero-Click™ Data Management System. The document focuses on comparing the new device to the predicate rather than presenting a standalone study with detailed acceptance criteria and performance metrics for the PC care™ software itself.

Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study details, ground truth types for original studies, etc.) is not directly available within the provided text. The document primarily details the software's features and its similarities and differences to the predicate device.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't list specific quantitative acceptance criteria with numerical performance targets for the PC care™ software. Instead, it compares features and functionalities to a predicate device to demonstrate substantial equivalence. The "performance" assessment is implied through the successful completion of validation activities and the belief in substantial equivalence.

Acceptance Criteria Category	Device Performance (PC care™ Blood Glucose Data Management Software)
Intended Use	Meets the intended use to help people with diabetes and their healthcare professionals in the review, analysis, and evaluation of glucose test results for effective diabetes management, by connecting to an i-SENS blood glucose meter and allowing automatic download of readings. (Similar to Predicate Device)
System Compatibility	Compatible with specified Windows OS versions (95, 98, ME, 2000, XP, Vista 32-bit, 7 32-bit), minimum CPU (300MHz Pentium 2), RAM (128 MB), hard disk space (60 MB), USB port, PC care™ USB cable, mouse/keyboard, 1024x768 monitor resolution, CD-ROM drive. (Similar to Predicate; some differences in minimum CPU and OS range, but deemed substantially equivalent)
Installation	Installed using CD and has the ability to uninstall. (Similar to Predicate)
Data Transmission/Download	Capable of uploading data from various devices by installing a software driver on PC, uses a USB cable, and auto-detects COM port. Includes a function that monitors communication status. Allows automatic download of blood glucose readings from the meter to the PC. (Similar to Predicate, with an added feature of communication status monitoring)
Operation and Features	Ability to access the program via icon/explorer, view owner's manual (via Help menu or CD file), email reports, personalize target ranges, set default target ranges, enter hypoglycemic range, set default favorite report, print reports. Allows manual data entry. Downloaded results cannot be edited or deleted; only manual entry results may be deleted. Input of additional information on patient and downloaded results (Health Profile, comment) is possible. Provides various report types (Trend Graph, Average Analysis, Histogram, Target Analysis, Logbook, Statistics, Period Comparison Graph) with color/black and white printing options. Includes capabilities for specifying complications and medications/insulin, and managing doctor, insurance, hospital, and diabetes educator information. (Many similar features to Predicate, with several enhanced features like communication monitoring, specific report types, and more detailed patient/therapy management capabilities).
Safety and Controls	Complies with general controls provisions of the Act (registration, listing, GMP, labeling, misbranding/adulteration prohibitions). Labeling is sufficient per 21 CFR Part 809.10.
Software Validation	Software Validation Report (SV-05-Q, SV-05-A) and specific test reports (TR-EI series for starting up, printing, email, downloading, manual entry, user profile, reports, install, communication protocol). (All these validation activities were included in the submission to demonstrate performance, implying they met internal acceptance criteria for these functionalities, but specific performance metrics are not listed.)

2. Sample Size for the Test Set and Data Provenance:

Sample Size for Test Set: Not specified in the provided text. The document lists software validation test reports (TR-EI-0xx), but does not detail the number of test cases, data points, or scenarios used in these tests.
Data Provenance: The company is i-SENS, Inc. located in Seoul, Republic of Korea. The study (software validation activities) would have been conducted to support the 510(k) submission, and likely uses data generated internally or in controlled test environments related to the i-SENS blood glucose meters. It is considered a regulatory submission for a software accessory, so the "data" being evaluated refers to the software's functionality and performance, not clinical data from patients. The study is prospective in the sense that the validation tests were conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

This information is not provided in the document. Software validation typically involves internal software testers or quality assurance personnel, but their number and specific qualifications are not detailed here. Given this is a software accessory for a glucose meter, the "ground truth" would relate to the software performing its intended functions correctly (e.g., accurately downloading data, generating correct graphs and statistics).

4. Adjudication Method for the Test Set:

This information is not provided. Software validation typically involves confirming expected outputs against actual outputs, and discrepancies would be resolved through debugging and re-testing. There's no mention of a formal expert adjudication method like 2+1 or 3+1 typically seen in diagnostic accuracy studies for image analysis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable and not performed. The PC care™ Blood Glucose Data Management Software is a data management tool for blood glucose meters, not an AI-assisted diagnostic device for human readers. It does not involve human "readers" interpreting medical images or data with or without AI assistance in the way an MRMC study evaluates. Its function is to organize, display, and analyze existing glucose data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, the software validation tests listed (TR-EI-0xx) represent a standalone assessment of the software's functionality. These tests evaluate if the software performs its intended functions (e.g., starting, printing, downloading, emailing, displaying reports) correctly, without continuous human intervention in its core computational and data handling processes. The "human-in-the-loop" here is the user who operates the software, but the validation is about the software's inherent capability.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this software validation would be based on the expected functional behavior and accuracy specifications of the software. For example:

For data download: The ground truth would be the actual blood glucose readings and associated timestamps stored in the i-SENS blood glucose meter. The software should accurately download and represent these.
For report generation: The ground truth would be the mathematically correct calculations (averages, statistics) and graphically accurate representations (trends, histograms) based on the downloaded data.
For user interface elements: The ground truth would be the specified design and functionality of buttons, menus, and data entry fields.

This is a form of functional and performance verification against design specifications and known correct outputs, rather than a clinical ground truth like pathology or expert consensus on a medical diagnosis.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. The PC care™ software is a rule-based data management system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its development would involve coding and testing against functional requirements and specifications.

9. How the Ground Truth for the Training Set was Established:

This is not applicable, as there is no "training set" for this type of software. The software's "ground truth" during development and testing would be established through its functional and technical specifications, which define how it should process data, generate reports, and interact with the user and the glucose meter.

Summary

{0}------------------------------------------------

K100937

Image /page/0/Picture/1 description: The image shows a logo with the text 'i:sen' inside a circle. There are two curved lines above the 'i' in 'i:sen', possibly representing an eye or a stylized element. The text is in a simple, sans-serif font, and the overall design is minimalist.

i-SENS, Inc. 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea

Tel. 82-2-916-6191

510(k) SUMMARY

(As required by 21.CFR.807.87)

DEC21 2010

According to the requirements of 21 CFR.807.92, the following information A. Introduction: provides data needed to understand the basis for determining substantial equivalence.
B. 510(k) Number is: K100937
Type of 510(k): Traditional C.
New submission for the Data Management Software which is an accessory D. Purpose for Submission: application for glucose meters.
Submitted By: E. i-SENS, Inc. 465-6, Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel.) +82-2-916-6191 Fax) +82-2-942-2514 www.i-sens.com
Dr. Hyun Joon Oh F. Contact Person: Tel.) +82-33-903-0760 Fax) +82-33-748-6191
Device Name: Trade name: PC care™ Blood Glucose Data Management Software G. Common Name: Data Management Software Classification Name: Unclassified (accessory to a BGM system)
PC care™ Blood Glucose Data Management Software is a software medical Type of Test: H. device that interfaces with the i-SENS blood glucose monitoring systems using the special USB cable (It is activated with the PC care™ program only).

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

I. System Description: 1) Device Description:

2) Operation principle:

The PC care™ Blood Glucose Data Management Software downloads all blood glucose test results along with their measurement dates and times from the i-SENS Blood Glucose Meters through the USB port connected to the PC with the special cable. The PC care Blood Glucose Data Management Software operates under a Microsoft Windows Operating System and provides reports containing variety of graphs and statistics based on User-selectable data interval and blood glucose target ranges.

3) System Requirements:

· CPU: 300 MHz Intel Pentium 2 or equivalent
· RAM: 128 MB or higher
· Minimum free hard disk space: 60 MB
· Windows 95, Windows 98, Windows ME, Windows 2000, Windows XP, Windows Vista (only 32bit), and Windows 7 (only 32bit).
· USB port
· PC care™ USB cable
· Mouse / Keyboard
· Video monitor and adapter with at least 1024x768 pixel screen resolution and 256 colors
· CD-ROM drive
· Printer (optional)

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

i-SENS. Inc. 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191

J. Regulation 1) Regulation section: Information: · 21 CFR Sec. 862.1345 - Glucose test system. · 21 CFR Sec. 862.2100 - Calculator/data processing module for clinical use. 2) Classification: Class II and I, respectively 3) Product code: · NBW - System, Test, Blood Glucose, Over The Counter · JQP - Calculator/Data Processing Module, For Clinical Use 4) Panel: 75, Chemistry
The PC care™ Blood Glucose Data Management Software is PC-based K. Intended Use: software intended for use in the home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for an effective diabetes management program. The PC care™ Blood Glucose Data Management Software connects to an i-SENS blood glucose meter, which comes with a PC care USB cable. The PC care™ Blood Glucose Data Management Software allows the user to download Blood glucose readings automatically from the meter to the PC.
We believe substantial equivalence to the Zero-Click™ Data Management L. Substantial Equivalence System previously submitted by AgaMatrix, Inc. and subsequently cleared Information: by FDA.

Predicate Device Name(s): Zero-Click™ Data Management System 2) Device Company: AgaMatrix, Inc. 3) Predicate 510(k) Number(s) : K062434

M. Comparison with The glucose measurement test principle: same as Zero-Click™ Data Management System Predicate Device (K062434): Intended Use: same as Zero-Click™ Data Management System

{3}------------------------------------------------

ﺎ،

1) Similarities
-----------------

Item	PC care™ Blood Glucose DataManagement Software (Device)	Zero-Click™ Data ManagementSystem (Predicate Device)
About User
Intended Use	The PC care™ Blood Glucose DataManagement Software is PC-basedsoftware intended for use in thehome and professional settings tohelp people with diabetes and theirhealthcare professionals in thereview, analysis and evaluation ofglucose test results for an effectivediabetes management program. ThePC care™ Blood Glucose DataManagement Software connects toan i-SENS blood glucose meter,which comes with a PC care USBcable. The PC care™ Blood GlucoseData Management Software allowsthe user to download Blood glucosereadings automatically from themeter to the PC with or withoutclicking a button.	The Zero-Click™ Data ManagementSystem is intended for use in thehome and professional settings to aidpeople with diabetes and theirhealthcare professionals in thereview, analysis and evaluation ofglucose test results to support aneffective diabetes managementprogram. It is an optional datamanagement software accessory foruse with the AgaMatrix's Liberty™Blood Glucose Monitoring System.The Zero-Click™ Data ManagementSystem allows users to downloadBlood glucose reading automaticallyfrom the meter to the PC withoutclicking a button.
Software use indications	Single or Multiple user settings	Single or Multiple user settings
About Installation
Installation of Program	Installed Using CD	Installed Using CD
Ability to uninstall	Yes	Yes
Computer SystemRequirements	CPU: Minimum 300MHz IntelPentium 2 or equivalentRAM: 128 MB or higher	CPU: Minimum 700MHz, IntelPentium processorRAM: Minimum 128 MB
Item	PC care™ Blood Glucose DataManagement Software (Device)	Zero-Click™ Data ManagementSystem (Predicate Device)
	Minimum free hard disk space: 60MB	Hard drive space: 60 MB Minimum(100 MB Recommended)
	Windows 95, Windows 98, Windows ME, Windows 2000, WindowsXP, Windows Vista (only 32bit),and Windows 7 (only 32bit).	Windows XP and Vista (32 bit)
	USB port	USB port
	PC care™ USB cable	Zero-Click™ Data Cable
	Mouse and keyboard	Mouse and keyboard
	Video monitor and adapter with atleast 1024x768 pixel screenresolution and 256 colors	Monitor: Minimum 1024x768resolution
	CD-ROM drive	CD-ROM drive
	Printer (optional)	Printer (optional)
Technical support	Yes	Yes
	About Transmission
Capable of uploadingdata from variousdevices	Software driver must be installed onPC	Software driver must be installed onPC
Cable availability	USB cable	USB cable
Auto-detect COM port	Yes	Yes
About Operation
Ability to access DMSprogram via icon orexplorer	Yes	Yes
Viewing the Owner'sManual	Click the Help menu in the programor personally open the manual file inthe installing CD.	Accessed via Help on toolbar or F1on computer
Ability to clear meterresults in memory	No	No
Item	PC care™ Blood Glucose DataManagement Software (Device)	Zero-Click™ Data ManagementSystem (Predicate Device)
Indication for primarytest method	Not available	Not available
Ability to email reportfrom PC directly fromprogram	Yes	Yes
Time Block	Before/After Breakfast,Before/After Lunch, Before/AfterDinner, Evening/Sleep Night	Before/After Breakfast,Before/After Lunch, Before/AfterDinner, Night
About Personal Settings
Units of measureautomatically set bycountry in setupinstallation	No	No
Ability to personalizetarget ranges	Yes	Yes
Ability to set defaulttarget range by diabetestype (Type I, Type IIGestational, etc.)	No	No
Default glucose targetranges available	Yes	Yes
Ability to enterhypoglycemic range	Yes	Yes
Ability to set defaultfavorite report	Yes	Yes
Ability to enter insulinregiment	No	No
Change meter audiocues	No	No
Item	PC care™ Blood Glucose DataManagement Software (Device)	Zero-Click™ Data ManagementSystem (Predicate Device)
Ability to print report	Yes	Yes
Result type display	No	No
Ability to view resultsand sort withoutgenerating report	No	No
About Modifying Results
Downloaded resultscannot be edited ordeleted	Yes	Yes
Manual data Entry	allowed	allowed
Ability to inputadditional informationon patient anddownloaded results	Yes - Health Profile, comment	Yes - Meal tag, Comments
Deleting Results	Only Manual entry results may bedeleted	Only Manual entry results may bedeleted
Ability to modify meteraverage results	Yes, 14, 30, 60, 90 days or custom	Yes, Today, 7, 14, 30, 60, 90 days orcustom
Ability to view controlresults	No	No
Ability to showcholesterol results/selectunits of measure	No	No
Ability to enter test sitefor manual result entry	No	No
Ability to inputadditional informationon manual result	Yes — comment	Yes - Meal tag, Comments
About Patient and Therapy Management
Required information	No	No
Item	PC care™ Blood Glucose DataManagement Software (Device)	Zero-Click™ Data ManagementSystem (Predicate Device)
on patient entry
Customizable schedule	Yes	Yes
Search patientcapability	No	No
Search for specificpatient in multiple(clinic) user function	No	No

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo and contact information for i-SENS, Inc. The logo includes the company name in a stylized font. The address is listed as 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea. The telephone number is Tel. 82-2-916-6191.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows a logo with the text "i-sens" in a stylized font. The "i" is lowercase and has a circular design above it, resembling an eye or a target. The rest of the text, "-sens", is in lowercase and connected to the "i". The logo has a clean and modern appearance.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo and contact information for i-SENS, Inc. The address is 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea. The telephone number is 82-2-916-6191.

{7}------------------------------------------------

465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea i-sens Tel. 82-2-916-6191

2) Differences

Item	PC care™ Blood Glucose DataManagement Software (Device)	Zero-Click™ Data ManagementSystem (Predicate Device)
About Transmission
Function that monitorsthe communicationstatus	Yes	No
About Operation
Ability to set meterclock to a specific dateand time	No	Yes
Copy saved databaseback to active DMSdatabase	No	Yes
Copy database toseparate file	No	Yes
About Personal Settings
Units of measuredisplay	Choice of mmol/L or mg/dL	Automatically selected based on unitalready set up in meter
Ability to change dateformat	No	Yes (M-d-yy or d-M-yy)
Item	PC care™ Blood Glucose DataManagement Software (Device)	Zero-Click™ Data ManagementSystem (Predicate Device)
Ability to synchronizemeter clock to PC upondownload	No	Yes
Ability to default tomanufacturer settings(mealtime slots, targetglucose ranges, etc.)	No	Yes
Ability to display12 or24 hour clock format	No	Yes
About Report
Report Types	Trend Graph, Average Analysis, .Histogram, Target Analysis,Logbook, Statistics, PeriodComparison Graph	Summary, Log Book, TargetAnalysis, Glucose Trend, Histogram,Average/Spread, Statistics
When printing Report,check if select functionfor the color/black andwhite mode exists	Yes	No
About Modifying Results
Ability to specifycomplicationsassociated with diabetesby patient	Yes	No
Specifying/Enteringmedications/insulin	Yes, up to 3 different insulin type	No
About Patient and Therapy Management
Diabetes control	Yes - Insulin list, Medication list,Diet/Exercise options	No
Doctor information	Yes - One doctor name may beentered	No
Item	PC careTM Blood Glucose DataManagement Software ( Device )	Zero-ClickTM Data ManagementSystem ( Predicate Device )
Deleting Patients and allaccompanying records	No	Yes
Insurance information	Yes - One insurance number may beentered	No
Hospital Information	Yes - One hospital name may beentered	No
Diabetes Educatorinformation	Yes - One diabetes Counselor maybe entered	No
Ability to inputadditional informationon patient	Yes - Date of diagnosis, InsulinInitial Date/Dosage Method, OralMedication Initial Date, Diet,Exercise, Working/Non-Workingday	No

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows a logo with the text "i-sens" in a bold, sans-serif font. To the left of the text, there is a circular graphic composed of three concentric circles. The innermost circle is solid, while the outer two are outlines. The logo appears to be for a company or product named "i-sens."

465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191

{9}------------------------------------------------

N.	Modifications:	Among various functions, only simple and essential functions have beenselected and incorporated for user convenience.
O.	Standard/GuidanceDocumentReferenced(if applicable):	1) FDA Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices2) Labeling - Regulatory Requirements for Medical Devices(FDA 89-4203)3) ISO 15197: 2003 In vitro diagnostic test system

Not Applicable P. Test Principle:

{10}------------------------------------------------

Validation The test reports in this table are included in this submission, and can be Q. Activities: found under the Section Numbers below.
- SV-05-Q. Software Validation Report (Question) ●
- SV-05-A. Software Validation Report (Answer) .
- � TR-EI-025-Starting Up Test
- . TR-E1-026-Printing Reports Test
- . TR-EI-027-Email Test
- TR-EI-028- CareSens N Download Readings Test
- TR-EI-029-Manual Entry Test
- TR-EI-030-User Profile Test
- TR-EI-031-Reports Test
- TR-EI-060-Install Test
- TR-EI-085-CareSens Communication Protocol .
- . TR-EI-113-CareSens II Download Readings Test
Proposed Labeling: The labeling is sufficient and it satisfies the requirement of 21 CFR Part R. 809.10.
The submitted information in this premarket notification is complete ડ. Conclusion: and supports a substantial equivalence decision.

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

I-Sens, Inc. c/o Hyun Oh 465-6 Wolgye-Dong, Nowon-Gu, Seoul, 139-845 KS - REPUBLIC OF KOREA

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

DEC 2 1 2010

Re: K100937

Trade/Device Name: PC care Blood Glucose Data Management Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system, Regulatory Class: II Product Code: NBW, JOP Dated: November 19, 2010 Received: November 19, 2010

Dear: Dr. Oh:

. . . .

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{12}------------------------------------------------

Page 2 –

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

CJC.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{13}------------------------------------------------

Indications for Use Form

510(k) Number (if known): ≤≤100937

Device Name: The PC care™ Blood Glucose Data Management Software Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

GARS

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k/00937

Page 1 of _

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
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.(b)
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.