LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067

K063409 · Agamatrix · NBW · Jan 12, 2007 · Clinical Chemistry

Device Facts

• Record ID: K063409
• Device Name: LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067
• Applicant: Agamatrix
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

AgaMatrix Liberty™ Blood Glucose Monitoring System: AgaMatrix Liberty™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip, palm, or forearm. Testing is done outside the body (in vitro diagnostic use). It is intended 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™ Blood Glucose Meter: AgaMatrix Liberty™ Blood Glucose 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 intended 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™ Blood Glucose Test Strips: AgaMatrix Liberty™ Blood Glucose is 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 intended 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 Solutions (Normal level and High level): AgaMatrix Liberty™ Control Solutions are intended for use with the AgaMatrix Liberty™ Meter and AgaMatrix Liberty™ Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Device Story

Portable, battery-operated blood glucose meter; uses test strips to measure glucose in fresh capillary whole blood samples (fingertip, palm, or forearm). Operated by patients at home or healthcare professionals in clinical settings. Device provides quantitative glucose concentration readout to assist in diabetes management. System includes meter, test strips, lancing device, and control solutions. No complex AI/ML processing described; standard electrochemical glucose monitoring principle.

Clinical Evidence

Clinical study of 49 subjects (Type II diabetes majority) compared forearm vs. fingertip glucose readings. Linear regression analysis showed slope 0.98 (lay user) and 1.01 (HCP), with 94-96% of results within ±20% of reference. Median glucose 152 mg/dL (range 84-320 mg/dL).

Technological Characteristics

Portable, battery-operated electrochemical glucose meter. Materials and design identical to predicate. Standards: ISO 15197:2003, ISO 14971:2000, IEC 61010-1, IEC 61010-2-101, IEC 61000-4-3.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from fingertip, palm, or forearm. Intended for home (OTC) use by persons with diabetes or clinical use by healthcare professionals to monitor diabetes control effectiveness.

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

• Liberty™ Blood Glucose Monitoring System (k052762)

Submission Summary (Full Text)

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K063409

JAN 12 2007

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

10 Manor Parkway Salem, NII 03079 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.

10 Manor Parkway

Salem NH 03079

Contact Person: Connie Hertel Director Quality & Regulatory Affairs Phone: (603) 328 - 605 l Fax: [phone]

Date Prepared: 09 November 2006

### 2. Device Name:

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

### 3. Predicate Device:

The Liberty™ Blood Glucose Monitoring System with the extended indication for use, the forearm, is substantially equivalent to the Liberty™ Blood Glucose Monitoring System for finger and palm stick, cleared under k052762.

### 4. Description of the Device

The AgaMatrix Liberty™ Blood Glucose Monitoring System includes a meter with batteries, compact carrying casc, 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/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. To the right of the word, there is a series of small squares that appear to be ascending in size, creating a visual effect.

## 510(k) Summary (Continued)

### 5. 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, palm, or forearm. The Liberty, TM Test Strips are for in vitro diagnostic (outside of the body) use only. The Liberty™ System is not intended for use with neonates.

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

The LibertyTM Blood Glucose Monitoring System has identical materials and Design as the cleared device ..

## 7. Testing

The manufacturer of the Liberty "M 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 clectrical 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 finger stick indication of use, the Liberty the Blood Glucose Monitoring System has the same intended uses, with identical technological chatacteristics 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/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font and is centered on the page. To the left of the text is a logo with three diagonal lines.

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Connie Hertel Director Quality & Regulatory Affairs AgaMatrix Inc. 10 Manor Parkway Salem, NH 03079

JAN 1 2 2007

Re: k063409 Trade/Device Name: LIBERTYTM 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: November 9, 2006 Received: November 13, 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 10gally marketed predicate device results in a classification for your device and thus, perceits 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 (2) Of Cran the Division of Small Manufacturers, International and Consumer Assistance at its toll the fire mumber [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Sean M. Cooper, M.S., D.V.M. 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 has the word "AgaMatrix" in a simple font. Above and to the right of the word is a series of four squares that are arranged to look like a stylized star.

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

## Indications for Use

510(k) Number: K063409

Device Name:

Liberty™ Blood Glucose Monitoring System Forearm Claim

Indications For Use:

AgaMatrix Liberty™ Blood Glucose Monitoring System:

AgaMatrix Liberty " Blood Glucose Monitoring System.
AgaMatrix Liberty " Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip, palm, or forearm. 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. It is not intended for use with neonates.

AgaMatrix Liberty™ 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 frearians courty whole blood. Testing sdone outside the body (in viro 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 effectiveress of diabetes control.

## AgaMatrix Liberty7M 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. 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 effective of por diabetes control.

## AgaMatrix Liberty TM Control Solutions (Normal level and High level):

rightants Liberty - Courrol Solutions (Normal Revel):
AgaMatix Liberty™ Control Solutions are intended for use with the AgaMarix Libery™ Meter and
AgaMatix Liberty™ Test Stri results.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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)

Carol Benson
n Sign-Off

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Citice of In Vitro Diagnostic Device I ivaluation and Safety "

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K 063409

CONFIDENTIAL