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.

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 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 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.

AgaMatix Liberty™ Control Solutions are intended for use with the AgaMarix Libery™ Meter and AgaMatix Liberty™ Test Stri results.

Device Description

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.

AI/ML Overview

The provided 510(k) summary for the AgaMatrix Liberty™ Blood Glucose Monitoring System (K063409) does not contain detailed information regarding the specific acceptance criteria and the comprehensive study results as typically expected for device validation.

Instead, it states that the device complies with certain ISO and IEC standards, which imply conformance to established performance requirements. However, the specific numerical acceptance criteria (e.g., accuracy percentages, precision limits) and the detailed results of studies demonstrating compliance are not explicitly provided in the given text.

Based on the provided document, here's what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance:

This information is not explicitly stated in the provided text. The document refers to compliance with ISO 15197:2003, which sets performance requirements for blood glucose monitoring systems for self-testing. However, the specific numerical criteria (e.g., accuracy within a certain percentage of a reference method) and the device's measured performance against those criteria are not listed.

2. Sample size used for the test set and the data provenance:

This information is not explicitly stated in the provided text. The document mentions "Testing" but does not detail the sample sizes for patient samples or control samples, nor their country of origin or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not explicitly stated in the provided text. For blood glucose monitoring systems, "ground truth" is typically established by laboratory reference methods, not by expert consensus on visual assessment.

4. Adjudication method for the test set:

This information is not applicable/not explicitly stated in the context of a blood glucose monitoring system's performance testing. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation) where multiple readers provide their opinion. For quantitative measurements like blood glucose, accuracy is determined by comparison to a reference method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device that involves human readers interpreting cases.

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

This information is not explicitly stated but is implicitly the primary mode of operation for a blood glucose meter. The "device performance" would inherently be its standalone performance, as it provides a direct measurement rather than an interpretation to a human.

7. The type of ground truth used:

This is not explicitly stated, but for blood glucose monitoring systems, the ground truth is universally established by laboratory reference methods (e.g., YSI analyzer). The document mentions "in vitro diagnostic (outside of the body) use only," which confirms the nature of the testing.

8. The sample size for the training set:

This information is not applicable/not explicitly stated. "Training set" refers to data used to develop and train machine learning models. A blood glucose monitoring system, based on electrochemical principles, does not typically involve a "training set" in the machine learning sense. Its performance is based on its sensor technology and calibration, not learned patterns from a dataset.

9. How the ground truth for the training set was established:

This information is not applicable for the reasons stated in point 8.

Summary of available and missing information:

Category	Information from Document
1. Acceptance Criteria & Reported Performance	Not explicitly stated in numerical form. The document states compliance with ISO 15197:2003, which outlines general requirements for blood glucose monitoring systems, but the specific performance results against these criteria are not provided.
2. Test Set Sample Size & Data Provenance	Not explicitly stated. "Testing" is mentioned, but details on sample size, country of origin, or retrospective/prospective nature are absent.
3. Experts for Ground Truth & Qualifications	Not applicable. Ground truth for blood glucose meters is typically a lab reference method, not expert consensus.
4. Adjudication Method	Not applicable. Adjudication methods (e.g., 2+1) are for subjective assessments, not for quantitative measurements like blood glucose.
5. MRMC Comparative Effectiveness Study (AI assistance)	Not applicable. This is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device.
6. Standalone Performance	Implicitly done. The device's performance as a blood glucose meter would inherently be its standalone performance.
7. Type of Ground Truth Used	Implicitly, laboratory reference methods. While not directly stated, "in vitro diagnostic" and the nature of blood glucose testing imply comparison to highly accurate laboratory analyzers.
8. Training Set Sample Size	Not applicable. This device uses electrochemical technology, not machine learning that requires a "training set."
9. Ground Truth for Training Set	Not applicable. (See point 8)

To get the specific acceptance criteria and detailed study results, one would typically need to refer to a more detailed clinical study report or the full submission documentation to the FDA, which is not provided in this 510(k) summary. The summary focuses on establishing substantial equivalence based on identical technological characteristics and compliance with general standards.

Summary

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K063409

JAN 12 2007

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10 Manor Parkway Salem, NII 03079 Office: +1 (603) 328-6000 Fax: +1 (603) 893-4191

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: (603) 893-4191

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

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510(k) Summary (Continued)

5. Intended use of the Device

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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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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Page 2 -

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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 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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10 Manor Parkway Salem, NH 03079 Office: +1 (603) 328-6000 Fax: +1 (603) 893-419T

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 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

Page 1 of __ 1

Citice of In Vitro Diagnostic Device I ivaluation and Safety "

K 063409

CONFIDENTIAL

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.