JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381

K083265 · Agamatrix, Inc. · NBW · Feb 3, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083265
• Device Name: JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381
• Applicant: Agamatrix, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 3, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

AgaMatrix JAZZ Wireless™ 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 JAZZ Wireless™ Blood Glucose Meter is intended for use with AgaMatrix JAZZ 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 JAZZ Blood Glucose Test Strips are intended for use with AgaMatrix JAZZ Wireless 110 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 WaveSense™ Control Solution is intended for use with the AgaMatrix JAZZ Wireless M Meter and AgaMatrix JAZZ Wireless Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Device Story

Portable, battery-operated blood glucose monitoring system; measures glucose in fresh capillary whole blood via test strips. Modification adds Bluetooth wireless capability for data upload to PC, replacing USB cable. Used by diabetics at home or clinicians in clinical settings. Provides quantitative glucose readings to assist in diabetes management. System includes meter, lancing device, lancets, control solution, and test strips.

Clinical Evidence

Bench testing only; validation protocols addressed hazards identified in System Risk analysis (FTA).

Technological Characteristics

Portable, battery-operated glucose meter. Connectivity: Bluetooth wireless for PC data upload. Standards: ISO 15197:2003, ISO 14971:2000, IEC 61010-1, IEC 61010-2-101, IEC 61000-4-3. Codeless technology.

Indications for Use

Indicated for use by patients with diabetes for the quantitative measurement of glucose in capillary whole blood.

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.

Submission Summary (Full Text)

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K083263

# FEB - 3 2009

AgaMatrix

l 0 Manor Parkway Salem, NH 03079 Office: [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.

The assigned 510(k) number is:

unknown

- 1. Submitter's Name, Address, Telephone Number, Contact Person, and date the summary was prepared.
Submitter's Name: AgaMatrix, Inc. 10 Manor Parkway Salem, NH 03079

| Contact Person: | Connie Hertel<br>Director Quality & Regulatory Affairs |
|-----------------|--------------------------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |

Date the summary prepared: September 30, 2008

### 2. Device Name -

| Trade/Proprietary Name: | WaveSense Jazz Wireless™ 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 |

## 3. Modification Device

The modification of Jazz Wireless™ blood glucose system allows users to upload glucose readings from the meter to a blue tooth enabled PC without the use of a USB cable.

### 4. Description of the Device:

The AgaMatrix Jazz Wireless™ Blood Glucose Monitoring System which is codeless, includes a meter with batteries, compact carrying case, lancing device, lancets, control solution and owner's booklet. Test Strips and control solution 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.

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

The Jazz Wireless™ 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 Jazz 10 test strips are for in vitro diagnostic (outside of the body) use only. The Jazz Wireless™ System is not intended for use with neonates.

## Testing:

The manufacturer of the Jazz Wireless™ 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 Wireless™ 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 bird-like figure with stylized wings.

### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Agamatrix Inc c/o Connie Hertel 10 Manor Parkway Salem, NH 03079

## FEB - 3 2009

Re: k083265

> Trade/Device Name: Jazz Wireless Blood Glucose Monitoring System, Model 8000-03381 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: January 5, 2009 Received: January 6, 2009

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 [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 the normalized [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Corg C. He

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

For the will be the mass

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Image /page/4/Picture/0 description: The image contains the word "AgaMatrix" in a simple, sans-serif font. The text is horizontally aligned and appears to be a logo or brand name. There are some small dots in the upper right corner of the image.

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

# Indications For Use

K083265 510(k) Number (if known): unknown AgaMatrix JAZZ Wireless"M Blood Glucose Monitoring System Device Name:

Indications for Use:

## AgaMatrix JAZZ Wireless™ Blood Glucose Monitoring System:

AgaMatrix AgaMatrix JAZZ Wireless™ 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 JAZZ Wireless™ Blood Glucose Meter:

AgaMatrix JAZZ Wireless™ Blood Glucose Meter is intended for use with AgaMatrix JAZZ 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 JAZZ Blood Glucose Test Strips:

AgaMatrix JAZZ Blood Glucose Test Strips are intended for use with AgaMatrix JAZZ Wireless 110 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 WaveSense™ Control Solution:

AgaMatrix WaveSense"10 Control Solution is intended for use with the AgaMatrix JAZZ Wireless M Meter and AgaMatrix JAZZ Wireless " Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Prescription X (21 CFR 801 Subpart D) AND/OR

Over the Counter X (21 CFR 801 Subpart C)

Mo (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Division Sign-Off Concurrence of CDRH Office of In Vitro Diagnostic Devices (OVD)

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

Office of In Vitro Diagnostic Device Evaluation and Safety

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