ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528

K062434 · Agamatrix · NBW · Nov 13, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062434
• Device Name: ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528
• Applicant: Agamatrix
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Zero-Click™ Data Management System is intended for use in the home and professional settings to aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the AgaMatrix's Liberty™ Blood Glucose Monitoring System. The Zero-Click™ Data Management System allows users to download Blood glucose reading automatically from the meter to the PC without clicking a button.

Device Story

Zero-Click™ Data Management System is an optional software accessory for AgaMatrix Liberty™ Blood Glucose Monitoring System; facilitates data transfer from meter to PC. Input: blood glucose test results, date, and time from meter memory via proprietary USB cable. Operation: automatic data upload without user button-press; software runs on Microsoft Windows. Output: reports, graphs, and statistics based on user-selectable date intervals and target ranges. Used in home and professional settings by patients and healthcare professionals. Benefit: eliminates manual data logs; provides enhanced glucose reading trends and statistics to support diabetes management.

Clinical Evidence

No clinical data provided; substantial equivalence based on design control activities, risk analysis, and verification/validation of software modification.

Technological Characteristics

Software-based data management accessory; operates on Microsoft Windows platform. Connectivity via proprietary USB cable for data transfer from blood glucose meter. No specific materials or sterilization required as it is a software-only accessory.

Indications for Use

Indicated for use by persons with diabetes (home/OTC) or healthcare professionals (clinical setting) to review, analyze, and evaluate 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.

Predicate Devices

• FreeStyle™ Connect Data Management System (k9944333)

Submission Summary (Full Text)

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AgaMatrix

10 Manor Parkway Salem, NH 03079 ()ffice: [phone] Fax: [phone]

## 510 (k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

NOW 1 3 2006

The assigned 510(k) number is:

K062434

- 1. Submitter's Name, Address, Telephone Number, Contact Person, and date the summary was prepared.

| Submitter's Name: | AgaMatrix, Inc.<br>10 Manor Parkway<br>Salem, NH 03079 |
|-------------------|--------------------------------------------------------|
| Contact Person: | Connie Hertel<br>Director Quality & Regulatory Affairs |
| Telephone: | [phone] |
| Fax: | [phone] |

Date the summary prepared:

August 17, 2006

#### 2. Device Name

| Classification Name: | None 1,2 |
|----------------------|---------------------------------------------|
| Common/Usual Name: | Data Management Software |
| Proprietary Name: | Zero-Click™ Blood Glucose Management System |

l Zero-Click™ Blood Glucose Management System is considered an "unclassified" accessory to a blood glucose test system, Product Code NBW

2 The regulation for the parent device (blood glucose monitor, Class II) is 21 CFR 862.1345, System Test , Blood Glucose.

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Image /page/1/Picture/0 description: The image shows the word "AgaMatrix" in a simple, sans-serif font. A curved line is located underneath the word, starting below the "A" and ending below the "x". To the right of the word, there are a few small, filled squares that appear to be arranged in a curved line.

10 Manor Parkway Salem, NH 03079 Office: [phone] Fax: [phone]

## 3. Legally Marketed Device to which Substantial Equivalence is Claimed:

| Predicate Device | 510(k) number |
|----------------------------------------------|---------------|
| FreeStyle™ Connect Data<br>Management System | k9944333 |

## 4. Intended Use of the Device

The Zero-Click™ Data Management System is intended for use in the home and professional settings to aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the AgaMatrix's Liberty™ Blood Glucose Monitoring System. The Zero-Click™ Data Management System allows users to download Blood glucose reading automatically from the meter to the PC without clicking a button.

## 5. Device Description

The Zero-Click™ Data Management System is an optional data management software accessory for use with the AgaMatrix's Liberty "M Blood Glucose Monitoring System. The Zero-Click™ Data Management System allows the transfer of data from the AgaMatrix's Liberty™ Blood Glucose meter to a personal computer for enhanced data management capability. The Zero-Click1131 Data Management System eliminates the need for manual data logs and provides enhance glucose reading trends and statistics. Using the unique Zero-Click™ USB cable, glucose readings are automatically downloaded from the Liberty™ Meter to a PC without pressing a button.

## 6. Principle of Operation

The Zero-Click™ Data Management System uploads each blood glucose test result and the date and time of the measurement from the memory of the AgaMatrix Liberty "M Blood Glucose meter through a unique USB cable, automatically without having to click a button.

The Zero-Click™ Data Management System operates in a Microsoft Windows Operating System platform and creates reports allowing the user to display a Variety of graphs and statistics based on user-selectable date intervals and blood glucose target ranges.

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Image /page/2/Picture/0 description: The image shows the word "AgaMatrix" in a simple, sans-serif font. A curved line underlines the word, and a series of dots trails off to the upper right of the word. The dots appear to be arranged in an arc shape.

10 Manor Parkway Salem, NH 03079 Office: [phone] Fax: [phone]

## 7. Summary of Data Demonstrating Substantial Equivalence

System testing was performed with the Zero-ClickTM Data Management System to ensure the optional accessory is equivalent to a currently marketed device (FreeStyle'™ Connect Data Management System). These tests consisted of system, hardware, software, and electrical safety (EMC, EMI, and ESD) and clinical user study which consisted of lay users with diabetes and Health Care Professionals (HCPs) to demonstrate the ease of operating the Zero-Click Data Management Software as intended.

Software verification and validation testing demonstrated that the Zero-Click™ Data Management System meets the performance requirements for the intended use of the optional accessory device and the resultant modification has not affected safety of effectiveness.

#### 8. Conclusions

Software verification and validation testing demonstrates that the Zero-Click™ Data Management System is safe and effective for its intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, rendered in black. The eagle's head is turned to the right, and its body is composed of flowing lines. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Connie Hertel AgaMatrix, Inc. 10 Manor Parkway Salem, NH 03079

NOV 1 3 2006

Re: k062434

> Trade/Device Name: AgaMatrix Liberty™ Blood Glucose Monitoring System AgaMatrix Liberty™ Blood Glucose Monitoring System with an Optimal Accessary the Zero-Click™ Blood Glucose Data Management Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system

Regulatory Class: Class II Product Code: NBW. CGA, JJX Dated: October 16, 2006 Received: October 17, 2006

Dear Ms. Hertel:

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).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The 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" (21CFR Part 807.97). 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.

Alberto Gutz

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

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for AgaMatrix. The logo consists of the word "AgaMatrix" in a simple, sans-serif font. There is a curved line underneath the word. To the right of the word, there are four small squares arranged in a curved line.

10 Manor Parkway Salem, NH 03079 Office: [phone] Fax: [phone]

#### Indications For Use

| 510(k) Number (if known): | K062434 |
|---------------------------|-----------------------------------------------------------------|
| Device Name: | AgaMatrix Liberty ^TM Blood Glucose Monitoring System |

# AgaMatrix Liberty™ Blood Glucose Monitoring System:

AgaMatrix LibertyTM Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

# AgaMatrix LibertyTM Blood Glucose Meter:

AgaMatrix Liberty™ Blood Glucose Meter is intended for use with AgaMatrix Liberty™ Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

# AgaMatrix LibertyTM Blood Glucose Test Strips:

AgaMatrix Liberty TM Blood Glucose Test Strips are intended for use with AgaMatrix Liberty™ Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

# AgaMatrix Liberty™ Control Solution:

AgaMatrix Liberty " Control Solution is intended for use with the AgaMatrix Liberty™ Meter and AgaMatrix Liberty™ Test Strips as a quality control check to verify the accuracy of blood glucose test results.

| Prescription<br>(21 CFR 801 Subpart D) | X | AND/OR | Over the Counter<br>(21 CFR 801 Subpart C) | X |
|----------------------------------------|---|--------|--------------------------------------------|---|
|----------------------------------------|---|--------|--------------------------------------------|---|

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Carl Benson*

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 2

Ro62434

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Image /page/6/Picture/0 description: The image shows the word "AgaMatrix" in a simple, sans-serif font. A curved line underlines the word, adding a subtle design element. Above and to the right of the word, there is a series of small squares that appear to be arranged in a curved or arced pattern, possibly suggesting a visual representation of a matrix or a network.

10 Manor Parkway Salem, NH 03079 Office: +} [phone] Fax: [phone]

#### Indications For Use

510(k) Number (if known):

lo2434

Device Name:

AgaMatrix Liberty 111 Blood Glucose Monitoring System with an Optional Accessary the Zero-Click™ Blood Glucose Data Management Software

## Zero-Click™ Blood Glucose Data Management Software

AgaMatrix Zero-Click™ Blood Glucose Data Management System is intended for use in the home and professional settings to aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the AgaMatrix LibertyTM Blood Glucose Monitoring System. The Zero-Click™ Blood Glucose Data Management System allows users to download Blood glucose reading automatically from the meter to the PC without clicking a button.

Prescription (21 CFR 801 Subpart D)

AND/OR

Over the Counter (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ()N ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C. Benson

sion Sign-Of

Office of In Vitro Diagnostic Device Evaluation and Safety

K062434

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