AgaMatrix JAZZ™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm, and/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.

AgaMatrix JAZZ™ Blood Glucose Meter is intended for use with AgaMatrix JAZZTM Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm, and/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.

AgaMatrix JAZZ™ Blood Glucose Test Strips are intended for use with AgaMatrix JAZZ™ Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm and/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.

AgaMatrix JAZZ™ Control Solutions are intended for use with the AgaMatrix JAZZ™ Meter and AgaMatrix JAZZ™ Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Device Description

The AgaMatrix JazzTM Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, Lancing device, lancets, control solution and owner's booklet. Test Strips are sold 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 AgaMatrix Jazz™ Blood Glucose Monitoring System is certified to comply with ISO 15197:2003, which sets out criteria for in vitro diagnostic test systems for blood glucose monitoring for self-testing in managing diabetes mellitus. The 510(k) summary provided does not explicitly state specific acceptance criteria values (e.g., accuracy percentages) or the device's reported performance against such criteria in a table format. It states that the device "performs as intended and raises no new safety or effectiveness issues," implying it meets the standards of ISO 15197:2003 and is comparable to a predicate device.

Here is the information extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to compliance with ISO 15197:2003 as the primary standard for performance. However, specific numerical acceptance criteria (e.g., accuracy percentages within a certain range) and the device's reported performance against these criteria are not explicitly detailed in the provided text. The submission states: "The manufacturer of the Jazz™ Blood Glucose Monitoring System certifies that the device complies with the following: ISO 15197:2003 In vitro diagnostic test systems - Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus."

Without further details from the full ISO 15197:2003 document or a more detailed performance summary, a specific table cannot be generated.

2. Sample size used for the test set and the data provenance:
Not explicitly stated in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable for this type of device (blood glucose monitoring system). Ground truth is typically established through reference laboratory methods.

4. Adjudication method for the test set:
Not applicable.

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:
Not applicable. This is a standalone diagnostic device, not an AI-assisted interpretation system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, the device is a standalone blood glucose monitoring system, and its performance would have been evaluated independently.

7. The type of ground truth used:
While not explicitly stated, for blood glucose monitoring systems, the ground truth is typically established using a reference laboratory method (e.g., a YSI analyzer) to measure blood glucose levels.

8. The sample size for the training set:
Not applicable for this type of device. The system likely uses fixed algorithms and calibration rather than a machine learning model that requires a training set in the conventional sense.

9. How the ground truth for the training set was established:
Not applicable (as there's no stated training set for a machine learning algorithm).

Summary

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AgaMatrix

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

510 (k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in JUL 2 0 2007 accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

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

Submitter's Name:	AgaMatrix, Inc.10 Manor ParkwaySalem, NH 03079
Contact Person:	Connie HertelDirector Quality & Regulatory Affairs
Telephone:	(603) 328-6000
Fax:	(603) 893-4191

Date the summary prepared:

May 17, 2007

2. Device Name

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

3. Modification Device:

The Jazz 104 Blood Glucose Monitoring System is a brand name change to the Liberty ™ Blood Glucose Monitoring System. Some user interface modifications were improved.

4. Description of the Device

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AgaMatrix

510(k) Summary (Continued)

5. Intended use of the device

The Jazz™ 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 Jazz™ Test Strips are for in vitro diagnostic (outside of the body) use only. The Jazz™ System is not intended for use with neonates.

4. Testing

The manufacturer of the Jazz™ Blood Glucose Monitoring System certifies that the 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 Jazz™ 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 2 0 2007

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

Re: K071393 Trade/Device Name: Jazz Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: June 28, 2007 Received: June 29, 2007

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 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 (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 the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (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.

Yéan 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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Indication for Use

510(k) Number (if known): K071393 Device Name: JAZZ™ Indication For Use:

AgaMatrix JAZZ™ Blood Glucose Monitoring System:

AgaMatrix JAZZ™ Blood Glucose Meter:

AgaMatrix JAZZ™ Blood Glucose Test Strips:

AgaMatrix JAZZ™ Control Solutions (Normal level and High level):

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use X . (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD) Caro Senson

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

510(k) K071393

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.