K Number
K152365
Device Name
AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System
Manufacturer
Date Cleared
2016-04-21

(244 days)

Product Code
Regulation Number
862.1345
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The AgaMatrix Jazz ™ Wireless 2 Blood Glucose Monitoring System is intended for selftesting outside the body (In vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates. The AgaMatrix Jazz™ Blood Glucose Test Strips are for use with the AgaMatrix Jazz™ Wireless 2 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
Device Description
The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System includes the AgaMatrix Jazz™ Wireless 2 Blood Glucose Meter and the AgaMatrix Jazz™ Blood Glucose Test Strips. The apply blood symbol is displayed for the user to apply blood to the test strip until the meter begins the test. When enough blood has been applied to the strip electrodes the meter detects trigger current from the test strip initiating the test countdown. When the countdown is complete a test result is displayed on the meter screen. The unit of measure displayed on the meter screen is fixed in mg/dL and cannot be modified by the user. The following items are included in the AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System: - 1 AgaMatrix Jazz™ Wireless 2 Glucose Meter . - . 1 Owner's Guide - . 1 Carry Case - 1 AgaMatrix Lancing Device . - . 10 AgaMatrix Lancets - AgaMatrix Jazz™ Blood Glucose Test Strips - - -1 Meter Pairing & Syncing Guide The following items are compatible with the AgaMatrix Jazz™ Wireless 2 Glucose Monitoring System and are available separately: - . AgaMatrix Glucose Control Solutions (cleared in K103544) - AgaMatrix Diabetes Manager Mobile Application (cleared in K132821) -
More Information

No
The summary describes a standard electrochemical blood glucose monitoring system. There is no mention of AI or ML in the device description, intended use, performance studies, or any other section. The device relies on detecting trigger current from the test strip and a simple countdown to display a result.

No
This device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels. It does not provide therapy or treatment, but rather provides information to aid in the management of diabetes.

No

The "Intended Use / Indications for Use" section explicitly states: "The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes..."

No

The device description explicitly states that the system includes a "Glucose Meter" and "Blood Glucose Test Strips," which are hardware components. While a compatible mobile application is mentioned, the core device is a physical meter.

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states: "The AgaMatrix Jazz ™ Wireless 2 Blood Glucose Monitoring System is intended for selftesting outside the body (In vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control."

This statement clearly indicates that the device is intended for use outside the body to diagnose or monitor a medical condition, which is the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System is intended for selftesting outside the body (In vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.

The AgaMatrix Jazz ™ Blood Glucose Test Strips are for use with the AgaMatrix Jazz™ Wireless 2 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

Product codes (comma separated list FDA assigned to the subject device)

NBW, CGA

Device Description

The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System includes the AgaMatrix Jazz™ Wireless 2 Blood Glucose Meter and the AgaMatrix Jazz™ Blood Glucose Test Strips. The apply blood symbol is displayed for the user to apply blood to the test strip until the meter begins the test. When enough blood has been applied to the strip electrodes the meter detects trigger current from the test strip initiating the test countdown. When the countdown is complete a test result is displayed on the meter screen. The unit of measure displayed on the meter screen is fixed in mg/dL and cannot be modified by the user.

The following items are included in the AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System:

  • 1 AgaMatrix Jazz™ Wireless 2 Glucose Meter .
  • . 1 Owner's Guide
  • . 1 Carry Case
  • 1 AgaMatrix Lancing Device .
  • . 10 AgaMatrix Lancets
  • AgaMatrix Jazz™ Blood Glucose Test Strips -
  • -1 Meter Pairing & Syncing Guide

The following items are compatible with the AgaMatrix Jazz™ Wireless 2 Glucose Monitoring System and are available separately:

  • . AgaMatrix Glucose Control Solutions (cleared in K103544)
  • AgaMatrix Diabetes Manager Mobile Application (cleared in K132821) -

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

fingertip

Indicated Patient Age Range

Not intended for use with neonates.

Intended User / Care Setting

Used by a single patient for self-testing outside the body (In vitro diagnostic use) by people with diabetes at home.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Precision/Reproducibility:

  • Within run precision: Venous blood samples depleted or spiked to five different glucose concentrations (30-50 mg/dL, 51-110 mg/dL, 111-150 mg/dL, 151-250 mg/dL, 251-400 mg/dL) were tested. Sample size: 118-120 replicates per strip lot per glucose concentration, across 3 lots and 12 meters per lot.
  • Intermediate precision: Three glucose control solutions were tested with 10 meters over 10 days using three different operators and three lots of test strips.

Linearity/Assay Reportable Range:

  • Sample size: Twelve prepared venous blood samples with glucose concentrations ranging from 18 to 610 mg/dL (as determined by YSI reference method). For each concentration, twelve replicates were tested for each of three lots of test strips. Study design and analysis followed CLSI EP6-A.

Analytical Specificity (Interference Testing):

  • Sample size: Three venous whole blood samples (glucose concentrations 75, 120, 300 mg/dL) spiked with potentially interfering substances. Each sample was measured on ten meters using three strip lots for a total of 30 replicates per sample. Study design and analysis followed CLSI EP7-A2 guidance. A dose response study was performed for ascorbic acid.

Method Comparison with Predicate Device:

  • Sample size: 124 whole blood samples (117 fresh capillary fingerstick, 7 altered blood samples) ranging from 35.9 - 539.8 mg/dL. Three lots of test strips were tested.
  • Data source: Blood glucose results obtained with the meter compared to plasma glucose results obtained using the YSI Model 2300 Glucose Analyzer (reference method).

User Performance Study:

  • Sample size: 100 lay users with Type 1 or Type 2 diabetes.
  • Data source: Blood glucose results obtained from the finger by the subjects using one lot of test strips were compared to the YSI 2300 reference results.

Altitude Study:

  • Sample size: Three venous blood samples with glucose concentrations of 50, 200, and 450 mg/dL.
  • Data source: Results obtained at 10,000 feet altitude and sea level were compared to those obtained with the YSI 2300 reference method.

Hematocrit Study:

  • Sample size: Venous whole blood samples at three glucose concentrations (40, 125, and 350 mg/dL) and nine hematocrit levels (20, 25, 30, 35, 40, 45, 50, 55, 60%). Each sample was measured with ten meters and three test strip lots for a total of 30 replicates.
  • Data source: Compared with the YSI 2300 reference method.

Temperature and Humidity Study:

  • Sample size: Venous whole blood samples tested at target glucose concentrations of 50, 200, and 450 mg/dL. Five temperature and humidity combinations were tested: low temperature/low humidity, low temperature/high humidity, high temperature/low humidity, high temperature/high humidity, and medium temperature/medium humidity (control condition). Each sample was tested with 30 replicates.
  • Data source: Meter results were compared to YSI reference analyzer.

Infection Control Studies (Robustness Testing):

  • Testing performed using PDI® Super Sani-Cloth® Germicidal Disposable Wipes (EPA number 9480-4).
  • Method: 260 cleaning/disinfection cycles designed to simulate 5 years of use.

Sample Volume Study:

  • Sample size: One lot of test strips tested at three glucose intervals (50-65, 100-120, 200-250 mg/dL), using ten blood glucose meters.
  • Method: Blood samples were tested at five sample volumes (1.0, 0.6, 0.5, 0.4, and 0.3 uL).
  • Data source: Compared to YSI values.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

1. Analytical performance:
a. Precision/Reproducibility:
- i. Within run precision:
- Study type: Precision
- Sample size: n=118-120 per strip lot per glucose concentration, 3 strip lots, 12 meters per lot.
- Key results:
- Glucose (mg/dL) / Combined SD (mg/dL) / Combined CV (%)
- 30-50 / 2.9 / 9.0
- 51-110 / 4.2 / 4.3
- 111-150 / 4.1 / 3.2
- 151-250 / 7.7 / 3.5
- 251-400 / 15.3 / 4.0
- ii. Intermediate precision:
- Study type: Precision
- Sample size: 10 meters over 10 days using 3 operators and 3 lots of test strips.
- Key results:
- Control Solution Level 1: Mean 57.1-57.8 mg/dL, SD 1.6-2.2 mg/dL, %CV 2.8-3.7
- Control Solution Level 2: Mean 134.0-137.9 mg/dL, SD 2.9-3.4 mg/dL, %CV 2.1-2.6
- Control Solution Level 4: Mean 342.5-345.5 mg/dL, SD 7.4-8.8 mg/dL, %CV 2.2-2.6
b. Linearity/assay reportable range:
- Study type: Linearity
- Sample size: 12 prepared venous blood samples spanning 18-610 mg/dL, 12 replicates per sample per lot, 3 test strip lots.
- Key results: The results (Lot 1: y = 1.02x - 0.90, R2=1.00; Lot 2: y = 1.00x + 0.94, R2=1.00; Lot 3: y = 1.01x - 0.05, R2=1.00) support the claimed glucose measurement range of 20 mg/dL to 600 mg/dL.
c. Traceability, Stability, Expected values:
- Test strip stability: 21 months unopened, 180 days opened.
- Control Solution: Cleared in K103544.
d. Detection limit:
- Key results: Reportable range 20 to 600 mg/dL.
e. Analytical specificity (Interference):
- Study type: Interference
- Key results: Ascorbic acid exhibited potential interference (upper limit for no significant interference at 2.9 mg/dL). A labeling limitation was added. All other 34 interferents tested showed no significant interference at the tested concentrations.

2. Comparison studies:
a. Method comparison with predicate device:
- Study type: Method comparison
- Sample size: 124 whole blood samples (117 fresh capillary fingerstick, 7 altered).
- Key results:
- For glucose concentrations

§ 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.

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Image /page/0/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a cascading manner.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

AGAMATRIX, INC. DAVID OLSEN VP QUALITY & REGULATORY AFFAIRS 7C RAYMOND AVENUE SALEM NH 03079

April 21, 2016

Re: K152365

Trade/Device Name: Agamatrix Jazz Wireless 2 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: April 12, 2016 Received: April 14, 2016

Dear Mr. Olsen:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Katherine Serrano -S

For: Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K152365

Device Name

AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System

Indications for Use (Describe)

AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System:

The AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System is intended for self-testing outside the body (In vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System is not for the diagnosis of, or screening for, diabetes and is not intended for use with neonates.

The AgaMatrix Jazz Blood Glucose Test Strips are for use with the AgaMatrix Jazz Wireless 2 Blood Glucose Meter to quantitatively measure blood glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

Type of Use (Select one or both, as applicable)
---------------------------------------------------

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

A. 510(k) Number:

K152365

B. Applicant:

AgaMatrix, Inc. 7C Raymond Avenue Salem, NH 03079 606 328 6064

Contact Person: David Olsen Date Summary Prepared: April 8, 2016

C. Measurand:

Capillary whole blood glucose

D. Type of Test:

Quantitative, Amperometric method, Glucose Oxidase (GO)

E. Purpose for Submission:

New Device

F. Proprietary and Established Names:

AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System

G. Regulatory Information:

    1. Regulation section
Product CodeClassificationRegulation SectionPanel
NBWClass II21 CFR 862.1345
Blood Glucose Test
SystemClinical Chemistry
75
CGAClass II21 CFR 862.1345
Glucose Oxidase, GlucoseClinical Chemistry
75

AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System

4

H. Intended Use:

    1. Intended use(s):
      Blood Glucose Monitoring
    1. Indication(s) for use:
      AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System:

The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The AgaMatrix Jazz ™ Wireless 2 Blood Glucose Monitoring System is intended for selftesting outside the body (In vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.

AgaMatrix Jazz™ Blood Glucose Test Strips:

The AgaMatrix Jazz ™ Blood Glucose Test Strips are for use with the AgaMatrix Jazz™ Wireless 2 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

    1. Special conditions for use statement(s):
    • It is intended to be used by a single person and should not be shared. ●
    • For over-the-counter use.
    • . It is not intended to be used for testing neonatal blood samples or the diagnosis or screening of diabetes.
    1. Special instrument requirements:

AgaMatrix Jazz™ Wireless 2 Blood Glucose Meter

5

I. Device Description:

The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System includes the AgaMatrix Jazz™ Wireless 2 Blood Glucose Meter and the AgaMatrix Jazz™ Blood Glucose Test Strips. The apply blood symbol is displayed for the user to apply blood to the test strip until the meter begins the test. When enough blood has been applied to the strip electrodes the meter detects trigger current from the test strip initiating the test countdown. When the countdown is complete a test result is displayed on the meter screen. The unit of measure displayed on the meter screen is fixed in mg/dL and cannot be modified by the user.

The following items are included in the AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System:

  • 1 AgaMatrix Jazz™ Wireless 2 Glucose Meter .
  • . 1 Owner's Guide
  • . 1 Carry Case
  • 1 AgaMatrix Lancing Device .
  • . 10 AgaMatrix Lancets
  • AgaMatrix Jazz™ Blood Glucose Test Strips -
  • -1 Meter Pairing & Syncing Guide

The following items are compatible with the AgaMatrix Jazz™ Wireless 2 Glucose Monitoring System and are available separately:

  • . AgaMatrix Glucose Control Solutions (cleared in K103544)
  • AgaMatrix Diabetes Manager Mobile Application (cleared in K132821) -

J. Substantial Equivalence Information:

    1. Predicate device name(s):
      iBGStar Blood Glucose Monitoring System
    1. Predicate 510(k) number(s):
      K103544

6

3. Comparison with predicate:

Similarities/Differences
ItemPredicate Device
iBGStar Blood Glucose
Monitoring System (K103544)Candidate Device
AgaMatrix Jazz™ Wireless
2 Blood Glucose
Monitoring System
Intended
Use/Indications
for UseThe iBGStar™ Blood Glucose
Monitoring System is intended for
the quantitative measurement of
blood glucose levels in fresh
capillary whole blood samples
drawn from the fingertip, palms
(at the base of the thumb), or
forearms. It is intended to be used
by a single patient and should not
be used for testing multiple
patients. The iBGStar™ Blood
Glucose Monitoring System is
intended for self-testing outside
the body (In vitro diagnostic use)
by people with diabetes at home
as an aid to monitor the
effectiveness of diabetes control.
The iBGstar Blood Glucose
Monitoring System is not for the
diagnosis of, or screening for
diabetes, and is not intended for
use with neonates.Same with the following
differences: Finger tip
sampling only
Detection
methodDynamic
ElectrochemistrySame
EnzymeGlucose
OxidaseSame
Calibration
CodingNon-CodingSame
Sample TypeCapillary whole
bloodCapillary whole
blood
Sample sitesfinger, forearm, upper arm
or palms (base of
thumb)Finger tip
Sample volume0.5 µLSame
Average test
time5 secondsSame
Test range20 - 600 mg/dLSame
Operating
Temperature50° - 104°FSame
Measurment
Range20 to 600 mg/dLSame
CalibrationPlasma EquivalentSame
Control levelsTwo LevelsSame
Operating
HumidityUp to 90%,10% -
90%
Hematocrit
range20 - 60%Same
Altitude StudyUp to 10,000 feetSame
ConnectivityMeter utilizes a 30-pin dock
connecter to directly connect to
iPhone /iPod touch or Apple
Lightning Adapters.Meter is Bluetooth capability
for communication with
appropriate iOS or Android
software application.
Meter sizeL- 56 mm, W-24 mm, H-10mmL-65 mm, W-30 mm,
H-10 mm
Weight8.5g18g
Number of results stored300300
Power SourceA polymer lithium-ion rechargeable battery(2) replaceable CR2032 3 volt, lithium batteries
Alternative Site TestingYes (Palm and Forearm)No (Fingertip sampling only)

7

AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System

8

K. Standard/Guidance Document Referenced (if applicable):

ISO 14971:2007 Medical devices - Application of risk management to medical devices

EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition (2005).

EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline (2003).

IEC 60601-1-2, Medical Electrical Equipment-Part1-2: General requirements for Basic Safety and Essential Performance-Collateral Standard: Electromagnetic Compatibility-Requirements and Tests-Edition 3.0:2007

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L. Test Principle:

The AgaMatrix Jazz™ Blood Glucose Test Strips contain the glucose oxidase (GOx) enzyme with a redox chemical mediator that produces an electrochemical signal in proportion to the glucose concentration in the blood sample. The AgaMatrix Jazz™ Wireless 2 Meter measures this signal, using dynamic electrochemistry to correct for common analytical interferences such as hematocrit.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

  • i. Within run precision was evaluated using venous blood samples depleted or spiked to five different glucose concentrations across the system measuring range (30-50 mg/dL, 51-110 mg/dL, 111-150 mg/dL, 151-250 mg/dL, 251-400 mg/dL). Each sample was tested on three lots of test strips using 12 meters per test strip lot. Ten replicates were tested per meter, test strip lot and glucose concentration. Results are summarized below:

| Glucose Concentration,
(mg/dL) | Strip
Lot | n | Mean (mg/dL) | SD (mg/dL) | CV
(%) |
|-----------------------------------|--------------|-----|--------------|------------|-----------|
| 30-50 | 1 | 118 | 34.8 | 2.4 | 6.9 |
| | 2 | 119 | 31.3 | 1.6 | 5.3 |
| | 3 | 119 | 30.6 | 2.6 | 8.5 |
| | Combined | | | 2.9 | 9.0 |
| 51-110 | 1 | 120 | 100.8 | 3.2 | 3.2 |
| | 2 | 120 | 96.4 | 3.9 | 4.0 |
| | 3 | 120 | 96.9 | 4.0 | 4.1 |
| | Combined | | | 4.2 | 4.3 |
| 111-150 | 1 | 120 | 132.9 | 2.6 | 2.0 |
| | 2 | 120 | 129.3 | 4.2 | 3.3 |

AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System

10

| Glucose Concentration,
(mg/dL) | Strip
Lot | n | Mean (mg/dL) | SD (mg/dL) | CV
(%) |
|-----------------------------------|--------------|-----|--------------|------------|-----------|
| | 3 | 120 | 128.5 | 3.9 | 3.0 |
| | Combined | | | 4.1 | 3.2 |
| 151-250 | 1 | 120 | 220.1 | 6.5 | 2.9 |
| | 2 | 120 | 221.1 | 7.7 | 3.5 |
| | 3 | 120 | 229.5 | 5.0 | 2.2 |
| | Combined | | | 7.7 | 3.5 |
| 251-400 | 1 | 120 | 388.0 | 9.9 | 2.5 |
| | 2 | 120 | 379.9 | 16.3 | 4.3 |
| | 3 | 120 | 380.4 | 17.3 | 4.6 |
| | Combined | | | 15.3 | 4.0 |

  • ii. Intermediate precision of the Kronos BGMS was established by evaluating three glucose control solutions, with multiple meters (10 meters) over multiple days (10 days) using three different operators and three lots of test strips. The results are summarized below:
Test Strip Lot 1
Control SolutionMean, mg/dLSD, mg/dL% CV
Level 157.11.62.8
Level 2134.03.42.6
Level 4343.58.52.5

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Test Strip Lot 2
Control SolutionMean, mg/dLSD, mg/dL% CV
Level 157.82.23.7
Level 2137.92.92.1
Level 4345.58.82.6
Test Strip Lot 3
Control SolutionMean, mg/dLSD, mg/dL% CV
Level 157.11.83.1
Level 2134.33.12.3
Level 4342.57.42.2

b. Linearity/assay reportable range:

Linearity was evaluated using three test strip lots and twelve prepared venous blood samples. Glucose concentrations of the samples, as determined by YSI reference method, were 18, 48, 78, 137, 196, 255, 314, 373, 432, 492, 551 and 610 mg/dL. For each glucose concentration, twelve replicates were tested for each lot of test strips. Study design and analysis followed CLSI EP6-A. The mean of values from the device were compared with those obtained from the YSI reference method. The results from regression analysis are summarized below:

Lot 1: y = 1.02x - 0.90, R2=1.00

Lot 2: y = 1.00x + 0.94, R2=1.00

Lot 3: y = 1.01x - 0.05, R2=1.00

The results of the study support the claimed glucose measurement range of 20 mg/dL to 600 mg/dL.

  • Traceability, Stability, Expected values (controls, calibrators, or methods): C.
    Traceability

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The device is factory calibrated. Further calibration by the user is not necessary for operation. The calibration is traceable to NIST SRM 917c.

Stability

Test strip stability:

The test strips remain unchanged compared to the test strips of the predicate device (iBGStar BGMS K103544). The test strips have a shelf life of 21 months when stored unopened at 8 ℃ to 30 ℃, and are stable for 180 days after first opening when stored within the recommended storage conditions.

Control Solution:

The control solutions compatible for use with the current device (AgaMatrix Control Solution Level 2 and Level 4 were previously cleared and stability and value assignment was established in K103544).

  • d. Detection limit:
    The reportable range for the AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System is 20 to 600 mg/dL.

e. Analytical specificity:

  • i. To assess potential interference, three venous whole blood samples (with glucose concentrations 75, 120, 300 mg/dL) were spiked with potentially interfering substances at high (toxic / pathological) levels. Study design and analysis followed CLSI EP7-A2 guidance. Each sample was measured on ten meters using three strip lots for a total of 30 replicates per sample. The effect of the potential interferent was assessed by calculating the average difference in glucose readings between the test sample with high interferent concentration and the control sample with low/no interferent. Significant interference was defined as a bias in readings between the tested and control sample of > ± 10 mg/dL for glucose concentrations ± 10% for glucose concentrations > 100 mg/dL.
    Among the 35 interferents tested, only ascorbic acid exhibited potential interference. Therefore, a dose response study was performed and the upper limit for no significant interference was estimated at 2.9 mg/dL. The following limitation has been added to the labeling: "If you are taking Vitamin C (ascorbic acid) at large doses you may get inaccurate results with this system."

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A summary of the concentrations of the potential interfering substances tested at which no significant interference is observed is summarized in the table below:

| Interferent | Highest
concentration tested
with no significant
interference (mg/dL) | Interferent | Highest concentration
tested with no
significant
interference (mg/dL) |
|-----------------------|--------------------------------------------------------------------------------|----------------------|--------------------------------------------------------------------------------|
| Acetaminophen | 20 | Lactose | 10 |
| Ascorbic acid | 3 | L-DOPA | 4 |
| Bilirubin, conjugated | 29 | Maltose | 278 |
| Bilirubin, Free | 20 | Mannitol | 53 |
| Caffeine | 6 | Methyl-DOPA | 1.5 |
| Ceftriaxone | 97 | PAM iodide | 80 |
| Cholesterol | 600 | Pralidoxime chloride | 52 |
| Creatinine | 5 | Salicylate | 60 |
| Dopamine | 0.09 | Sorbitol | 600 |
| EDTA | 0.1 | Sucrose | 20 |
| Fructose | 18 | Tolazamide | 5 |
| Galactose | 120 | Tolbutamide | 64 |
| Gentisic acid | 1.8 | Triglyceride | 3300 |
| Glutathione | 92 | Uric acid | 23.5 |
| Hemoglobin | 200 | Xylitol | 60.9 |
| Heparin | 1.9 | Xylose | 120 |
| Ibuprofen | 50 | α-Lipoic acid | 2 |
| Icodextrin | 620 | | |

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f. Assay cut-off:

Not applicable.

2. Comparison studies:

a. Method comparison with predicate device:

The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System accuracy was evaluated using 124 whole blood samples (117 obtained by fresh capillary fingerstick and 7 altered blood samples) ranging in concentration from 35.9 -539.8 mg/dL. Three lots of test strips were tested in the study. Blood glucose results obtained with the meter to the plasma glucose results obtained using the YSI Model 2300 Glucose Analyzer. The study concluded that the AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System demonstrates acceptable system accuracy. The results of the study are summarized below:

LotWithin ± 5 mg/dLWithin ± 10 mg/dLWithin ± 15 mg/dL
119/32 (59.4%)29/32 (90.6%)31/32 (96.9%)
221/32 (65.6%)30/32 (93.8%)32/32 (100.0%)
316/32 (50.0%)30/32 (93.8%)32/32 (100.0%)
Combined56/96 (58.3%)89/96 (92.7%)95/96 (99.0%)

For glucose concentrations