LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067

K052762 · Agamatrix, Inc. · NBW · Jan 23, 2006 · Clinical Chemistry

Device Facts

• Record ID: K052762
• Device Name: LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067
• Applicant: Agamatrix, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Liberty™ Blood Glucose Monitoring System is intended to quantitatively measure blood glucose levels, also known as blood sugar, from fresh capillary whole blood samples taken from the fingertips or the palm. The Liberty™ Test Strips are for in vitro diagnostic (outside of the body) use only. The Liberty M System is not intended for use with neonates.

Device Story

System measures glucose in fresh capillary whole blood (fingertip/palm) via electrochemical biosensor technology using glucose oxidase enzyme. User applies blood to test strip; meter detects sample, performs electrochemical measurement, and displays result. Used at home (OTC) or in clinical settings to monitor diabetes control. Meter stores 300 results, calculates averages (breakfast, lunch, dinner, bedtime), and generates 14/30/90-day trend graphs. Provides plasma-equivalent results. Benefits include real-time glucose monitoring for diabetes management.

Clinical Evidence

Clinical study compared lay user results (fingertip/palm) to HCP results and YSI 2300 reference method. 166 samples in user study; 98% of palm results within Zone A of consensus error grid. Linearity demonstrated 20-600 mg/dL. Precision testing (n=10 meters) showed CVs 1.2-5.0%. Interference testing performed for bilirubin, uric acid, acetaminophen, triglycerides, and ascorbic acid.

Technological Characteristics

Portable, battery-operated glucose meter. Uses test strips for in vitro diagnostic measurement of capillary whole blood. Complies with ISO 15197:2003, ISO 14971:2000, IEC 61010-1, IEC 61010-2-101, and IEC 61000-4-3. Features include faster test time and reduced sample volume compared to predicate.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from fingertip and palm. For in vitro diagnostic use by persons with diabetes (OTC) or healthcare professionals in clinical settings to monitor diabetes control effectiveness. Not for use with neonates.

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

• Bayer Ascensia Contour Blood Glucose Monitoring System (k023657)

Submission Summary (Full Text)

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AgaMatrix

JAN 2 3 2006

230 Albany Street Cambridge, MA 02139 Office: [phone] Fax: [phone]

# 510 (k) Summary

In accordance with the requirements of SMDA 1990, and 21 CFR 807.92, this 510(k) Summary is provided:

#### 1. Submitted by:

AgaMatrix, Inc.

230 Albany Street

Cambridge, MA 02139

Contact Person: Connie Hertel Director Quality & Regulatory Affairs Phone: [phone] x25 Fax: (617) 588 - 0430

Date Prepared: 23 September 2005

#### 2. Device Name:

| Trade/Proprietary Name: | Liberty ^TM Blood Glucose Monitoring System |
|-------------------------|-------------------------------------------------------|
| Common/Usual Name: | Blood Glucose Monitoring System |
| Classification Name: | Glucose test system (per 21 CFR 862.1345) |
| Class: | II |
| Panel: | Chemistry |

#### Predicate Device: 3.

The Liberty™ Blood Glucose Monitoring System is substantially equivalent to the Ascensia Contour Blood Glucose Monitoring System, cleared under K023657.

#### 4. Description of the Device

The AgaMatrix Liberty™ Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, quick start guide, reference guide, owner's booklet, and warranty/ registration card. Test Strips, Lancing device, Lancets, and Control Solution are purchased separately.

It is intended for over-the-counter home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by healthcare professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument.

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Image /page/1/Picture/16 description: The image shows the logo for AgaMatrix. The logo consists of the word "AgaMatrix" in a simple, sans-serif font. A curved line underlines the word, and a series of small squares are positioned to the upper right of the word.

230 Albany Street Cambridge, MA 02139 Office: [phone] Fax: [phone]

### 510(k) Summary (Continued)

#### ડ. Intended use of the Device

The Liberty™ Blood Glucose Monitoring System is intended to quantitatively measure blood glucose levels, also known as blood sugar, from fresh capillary whole blood samples taken from the fingertips or the palm. The Liberty™ Test Strips are for in vitro diagnostic (outside of the body) use only. The Liberty "M System is not intended for use with neonates.

### Summary of the technological characteristics of the device compared to the 6. predicate device

The Liberty™ Blood Glucose Monitoring System has similar materials and basic design. The new device contains additional features compared to the predicate device. These additional features include faster test time, smaller sample size, and better accuracy.

### 7. Testing

The manufacturer of the Liberty™ Blood Glucose Monitoring System certifies that its device complies with the following:

ISO 15197:2003 In vitro diagnostic test systems - Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus

ISO 14971:2000 Medical devices - Application of risk management to medical devices

IEC 61010-1 Medical electrical equipment - General requirements for safety

IEC 61010-2-101 Safety requirements for electrical equipment for measurement, control and laboratory use - particular requirements for in vitro diagnostic (IVD) medical equipment

IEC 61000-4-3 Electromagnetic compatibility (EMC)

#### 8. Conclusions

Based upon the testing and comparison to the predicate device, the Liberty "M Blood Glucose Monitoring System has the same intended uses, with similar technological characteristics as the predicate device. The system performs as intended and raises no new safety of effectiveness issues.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 3 2006

Ms. Connie Hertel Director Quality & Regulatory Affairs AgaMatrix Inc. 230 Albany Street Cambridge, MA 02139

Re: k052762

> Trade/Device Name: AgaMatrix Liberty™ Blood Glucose Monitoring System Regulation Number: 21 CFR \$862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: December 22, 2005 Received: January 10, 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. Iisting 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 Guti

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/4/Picture/0 description: The image shows the logo for AgaMatrix. The logo consists of the word "AgaMatrix" in a simple, sans-serif font. A curved line underlines the text, and a series of small squares are arranged in an arc above and to the right of the word.

230 Albany Street Cambridge, MA 02139 Office: [phone] Faz: [phone]

## Indications for Use

K052762 510(k) Number:

_AgaMatrix LibertyTM Blood Glucose Monitoring System Device Name:

Indications For Use:

### AgaMatrix LibertyTM Blood Glucose Monitoring System:

AgaMatrix Liberty 116 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip and palm of the hand. 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 The 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 from the fingertip and palm of the hand. 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™ 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 from the fingertip and palm of the hand. 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 "M Control Solutions (Normal level and High level):

AgaMatrix Liberty™ Control Solutions are intended for use with the AgaMatrix Liberty™ Meter and
AgaMatrix Liberty™ Test Strips as a quality control check to verify the accura results.

Prescription Use × (Part 21 CFR 801 Subpart D)

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Over-The-Counter Use X (21 CFR 807 Subpart C)

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

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

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Office of In Vitro Diagnostic Device Evaluation and Safety

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