SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM

K132929 · Sd Biosensor, Inc. · NBW · Aug 5, 2015 · Clinical Chemistry

Device Facts

• Record ID: K132929
• Device Name: SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Sd Biosensor, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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 SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used to transmit glucose values to compatible mobile application or PC software through use of radio frequency communication. SD GlucoNavii® Mentor NFC Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor NFC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavi® Mentor NFC Multi Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended to transmit glucose values to compatible mobile application or PC software through use of radio frequency communication. SD GlucoNavii® Mentor NFC Multi Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor NFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

Device Story

System uses electrochemical biosensor technology to measure glucose in capillary blood samples; glucose oxidase (GOD) on test strips reacts with blood to generate electric current proportional to glucose concentration. Meter converts current to glucose value; displays results on LCD. Features NFC and USB connectivity for data transmission to mobile apps or PC software (GlucoNavii DMS). Used by patients at home or healthcare professionals in clinics. Provides quantitative glucose readings to aid diabetes control monitoring; supports hypo warnings and pre/post-meal marking. Benefits include convenient data tracking and management via digital integration.

Clinical Evidence

System accuracy evaluated via method comparison with predicate per ISO 15197. User performance studies conducted with lay consumers using capillary blood from fingertip, palm, forearm, and upper arm to demonstrate accuracy. No clinical sensitivity/specificity testing required.

Technological Characteristics

Electrochemical biosensor using glucose oxidase (GOD). Plasma-calibrated. Sample volume 0.3 µL. Measuring range 20-600 mg/dL. Power: 3V CR2032 battery. Connectivity: NFC and USB. Standards: IEC 61010-1, IEC 61010-2-101, IEC 60601-1-2, FCC Part 15.255.

Indications for Use

Indicated for quantitative blood glucose measurement in people with diabetes. Not for neonates, critically ill, or screening/diagnosis of diabetes. Not for use in dehydrated, hypertensive, hypotensive, shock, or hyperosmolar patients. AST not for CGM calibration or insulin dosing.

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

• SmartLink™ GOLD Blood Glucose Monitoring System (K100398)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k132929

B. Purpose for Submission:
New device

C. Measurand:
Capillary whole blood from the finger, palm, forearm, and upper arm

D. Type of Test:
Quantitative Amperometric Assay (Glucose Oxidase)

E. Applicant:
SD Biosensor Inc.

F. Proprietary and Established Names:
SD GlucoNavii Mentor NFC Blood Glucose Monitoring System
SD GlucoNavii Mentor NFC multi Blood Glucose Monitoring System

G. Regulatory Information:
1. Regulation section:
862.1345, Glucose Test System
2. Classification:
Class II
3. Product code:
NBW-System, Test, Blood Glucose, Over-the-Counter
CGA- Glucose test system

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4. Panel:

(75) Chemistry

H. Intended Use:

1. Intended use(s):

See indications for use below.

2. Indication(s) for use:

SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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 SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used to transmit glucose values to compatible mobile application on PC software through use of radio frequency communication.

The SD GlucoNavii® Mentor NFC Blood Glucose Test Strips are for use with the SD GlucoNavii® Mentor NFC Blood Glucose Meter to quantitatively measure glucose (sugar) fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use landing devices.

The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used to transmit glucose values to compatible mobile application on PC software

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through use of radio frequency communication.

The SD GlucoNavii® Mentor NFC Multi Blood Glucose Test Strips are for use with the SD GlucoNavii® Mentor NFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

3. Special conditions for use statement(s):
- For In Vitro Diagnostic Use only
- Do not use for screening or diagnosis of diabetes mellitus.
- Not for use in the critically ill.
- Not intended for use on neonates.
- Not to be used for individuals who are dehydrated, hypertensive, hypotensive or in shock.
- Not for use in hyperosmolar patients
- AST should not be used to calibrate CGMs or in insulin dose calculation.
- AST should only be used during periods of steady state blood glucose conditions.

4. Special instrument requirements:
SD GlucoNavii Mentor NFC meter
SD GlucoNavii Mentor NFC Multi meter

I. Device Description:

The SD GlucoNavii Mentor NFC and SD GlucoNavii Mentor NFC Multi Blood Glucose Monitoring Systems are over the counter and prescription blood glucose monitoring systems. The NFC BGMS is indicated for single patient use at home and should not be shared, while the NFC Multi BGMS is for multi-patient use in a professional healthcare setting, in order to help monitor the effectiveness of diabetes control.

The meter comes with near field communication (NFC). NFC is a set of standards for smart devices to establish radio communication with each other by touching them together or bringing them into close proximity. This function is compatible for test results back-up on PC or smart devices.

The BGMS comes with one level of SD Glucose Control Solution (Level M previously cleared in k123517) and SD GlucoMentor Test Strips or SD GlucoMentor Multi Test Strips. The SD Glucose Control Solutions are used to verify the performance of the SD GlucoNavii Mentor BGMS. The device comes with a SD Glucose check strip which is used to check the performance of the meter, before using the meter for the first time, whenever a result does not agree with the level felt by the patient or if the patient has repeated a test and the blood glucose result is still lower or higher than expected.

J. Substantial Equivalence Information:

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1. Predicate device name(s): SmartLink Gold
2. Predicate 510(k) number(s): k100398
3. Comparison with predicate:

| Similarities | | | |
| --- | --- | --- | --- |
| Item | Candidate Device SD GlucoNavii Mentor NFC BGMS k132929 | Candidate Device SD GlucoNavii Mentor NFC Multi BGMS k132929 | Predicate Device SmartLink GOLD BGMS k100398 |
| Intended use | It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes as an aid to monitor the effectiveness of diabetes control. | It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes as an aid to monitor the effectiveness of diabetes control. | same |
| Detection Method | Glucose Oxidase biosensor | Glucose Oxidase biosensor | same |
| Measuring range | 20-600mg/dL | 20-600mg/dL | same |
| Hematocrit range | 20-60% | 20-60% | Same |
| Sample Type | Fresh capillary whole blood from fingertips | Fresh capillary whole blood from fingertips | same |
| Alternate site testing (AST) | Palm, forearm, upper arm | Palm, forearm, upper arm | Same |
| Operating temperature range | 50°F-113°F (10°C-45°C) | 50°F-113°F (10°C-45°C) | same |
| Humidity | 15-95% | 15-95% | Same |
| Altitude | Up to 11,351 feet | Up to 11,351 feet | Same |
| Test time | 5 seconds | 5 seconds | Same |
| Power source | 3V CR2032 battery | 3V CR2032 battery | Same |
| PC connection/transmission function | USB cable | USB cable | Same |
| Voice feature | No | No | No |
| Test strip storage | 36-90°C 10-95% RH | 36-90°C 10-95% RH | Same |
| Differences | | | |
| --- | --- | --- | --- |
| Item | Candidate Device SD GlucoNavii Mentor NFC BGMS k132929 | Candidate Device SD GlucoNavii Mentor NFC Multi BGMS k132929 | Predicate Device SmartLink GOLD BGMS k100398 |
| Sample Volume | 0.3uL | 0.3uL | 0.9uL |

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| Differences | | | |
| --- | --- | --- | --- |
| Item | Candidate Device
SD GlucoNavii Mentor
NFC BGMS
k132929 | Candidate Device
SD GlucoNavii Mentor
NFC Multi BGMS
k132929 | Predicate Device
SmartLink GOLD
BGMS
k100398 |
| Dimensions | 50mm x 93mm x 18m | 50mm x 93mm x 18m | 47mm x 95mm x 17.5mm |
| Memory | 300 test results | 300 test results | 400 test results |
| Meter Weight | 50g with battery | 50g with battery | 47.5g with battery |
| Test strips | SD GlucoMentor™
NFC Blood Glucose
Test Strips | SD GlucoMentor™ NFC
Multi Blood Glucose
Test Strips | SmartLink Gold Test Strip |

K. Standard/Guidance Document Referenced (if applicable):
- ISO14971:2007: Medical devices - Applications of risk management to medical devices
- CLSI EP05-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition
- CLSI EP09-A2: 2004: Method Comparison and Bias Estimation Using Patient Samples
- IEC 60601-1-2 EDITION 3: 2007-03, Medical Electrical Equipment-Part 1-2: General Requirements for basic safety and essential performance-collateral standard: electromagnetic capability-requirements and tests (General II IES/EMS)

L. Test Principle:

SD GlucoNavii® Mentor NFC and NFC Multi Blood Glucose Monitoring Systems are electronic devices that utilize the amperometric biosensor technology for measuring the glucose level in human blood. A drop of blood sample from the finger prick works with glucose oxidase and the mediators in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current. Within five seconds, the level of blood glucose will be shown on the digital display screen.

M. Performance Characteristics (if/when applicable):

1. Analytical performance: Performance testing was conducted on the SD GlucoNavii Mentor NFC meter as the GlucoNavii Mentor NFC Multi meter is the same meter and share the same performance. The only difference is in the intended user.

a. Precision/Reproducibility:

Repeatability: Venous blood was spiked with five different glucose concentrations (30-50, 51-110, 111-150, 151-250, and 251-400mg/dL) and tested on 10 SD GlucoNavii Mentor NFC meters and 4 lots of test strips. Ten replicates were tested per meter per glucose concentration. The results from one representative lot are

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summarized below:

| Glucose Concentration | N | Mean (mg/dL) | SD (mg/dL) | %CV |
| --- | --- | --- | --- | --- |
| 30-50 | 100 | 53.4 | 1.4 | 2.4 |
| 51-110 | 100 | 87.9 | 1.7 | 1.9 |
| 111-150 | 100 | 133.7 | 3.2 | 2.4 |
| 151-250 | 100 | 203.8 | 3.9 | 1.9 |
| 251-400 | 100 | 328.4 | 5.9 | 1.8 |

## Intermediate Precision

Intermediate Precision was evaluated using three lots of test strips and ten SD GlucoNavii NFC meters. Glucose control solutions in three concentration ranges were used (55-85, 88-132, 264-396mg/dL). For each level of control, ten replicates were taken each day for ten days, so that 100 individual measurements were generated per control level. The results from all strip lots are summarized below:

Original study

| Control Level (mg/dL) | N | Mean (mg/dL) | SD (mg/dL) | %CV |
| --- | --- | --- | --- | --- |
| Level L | 100 | 70.6 | 2.98 | 4.2 |
| Level M | 100 | 113.1 | 3.9 | 3.4 |
| Level 3H | 100 | 332.6 | 13.2 | 3.98 |

## b. Linearity/assay reportable range:

The claimed measuring range for this device is 20-600mg/dL. Linearity was evaluated using 3 lots of test strips, 5 SD GlucoNavi Mentor NFC meters and 13 venous whole blood samples with the following glucose concentrations: 16.6, 22.1, 54.3, 86.4, 157.5, 227.3, 297.5, 368.3, 438.8, 509.3, 579.3, 649.8 and 719.8mg/dL, obtained by spiking with glucose solution. Each glucose level was analyzed 5 times on each meter. The sponsor states that the 5 SD GlucoNavii Mentor NFC meters are specially designed having an unlimited possible range of measurement; however, will read Lo for values under 20mg/dL and HI for values greater than 600mg/dL. Linear regression analysis compared to YSI resulted in the following:

Lot 1: $y = 1.011x - 1.964; R^2 = 0.999$

Lot 2: $y = 1.006x - 1.202; R^2 = 0.999$

Lot 3: $y = 1.008x - 2.159; R^2 = 0.999$

Combined: $y = 1.009x - 1.775; R^2 = 0.999$

The study results support the claimed measuring range of 20-600mg/dL.

## c. Traceability, Stability, Expected values (controls, calibrators, or methods):

### Traceability:

The traceability for the SD GlucoNavii Mentor NFC Blood Glucose Monitoring system is traceable to the NIST SRM 917b reference material. The method

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comparison study was performed using the candidate device and YSI as the reference method.

## Test strip stability:

When stored at the recommended storage temperature of 36°F to 90°F and the relative humidity of 10-95%, the unopened shelf-life is 24 months and once opened, the test strips are stable for up to 6 months.

## Control solution stability:

Control solution stability previously established in k100398. The unopened shelf-life for the control solutions is 24 months at the recommended storage of 46°F to 86°F. Once opened, the control solutions are stable for 3 months when stored at 46°F to 86°F.

## Value assignment:

Value assignment for the controls was previously established in k100398.

## d. Detection limit:

The measuring range of the device is 20-600mg/dL. This range is validated via linearity study. See section M.1.b.

## e. Analytical specificity:

The sponsor performed interference studies with spiked venous blood samples at 2 different glucose concentrations (65 and 250mg/dL). The samples were divided into 4 groups (1 control/non-treated and 3 treated). Each sample was measured twice by the reference method and once with 10 GlucoNavii Mentor NFC meters and one lot of test strips. The following table lists the concentrations of each substance at which no significant interference was detected.

| Potential Interferent | Concentration at which no significant interference is observed (mg/dL) |
| --- | --- |
| Acetaminophen | 6 |
| Ascorbic acid | 4 |
| Ibuprofen | 50 |
| Methyl dopa | 2 |
| Dopamine | 2.5 |
| Tolbutamide | 100 |
| Bilirubin | 35 |
| Triglyceride | 1500 |
| Uric acid | 5 |
| Creatinine | 30 |
| Hemoglobin | 200 |
| Total Cholesterol | 500 |

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| Acetylsalicylic acid | 120 |
| --- | --- |
| Fructose | 15 |
| Galactose | 60 |
| Tetracycline | 5 |
| Urea | 500 |
| Tolazamide | 5 |
| Warfarin | 1 |
| Levodopa | 4 |
| Sodium Fluoride | 200 |
| Maltotetraose | 120 |
| Mannose | 5 |
| Lactose | 25 |
| Mannitol | 800 |
| Sorbitol | 10 |
| Xylitol | 25 |
| Maltose | 500 |
| Sodium salicylate | 63 |
| Xylose | 50 |
| Maltotriose | 240 |
| EDTA | 200 |
| Gentisic acid | 1.8 |
| Glutathione | 4.6 |
| Ethanol | 400 |
| Heparin | 3000 IU/L |

f. Assay cut-off:

Not applicable

2. Comparison studies:

a. Method comparison with predicate device:

a. Method comparison with predicate device:

System Accuracy

System Accuracy was performed on 10 SD GlucoNavii Mentor NFC meters and 4 lots of test strips over 10 days. Two hundred twenty (220) fresh capillary samples from finger punctures ranging from $26 - 464\mathrm{mg / dL}$ and 100 fresh samples from the palm, forearm and upper arm were collected and measured on two meters followed by YSI. To achieve glucose concentration less than $50\mathrm{mg / dL}$ , 6 samples were glycolyzed. To achieve glucose concentration greater than $400\mathrm{mg / dL}$ 6 samples were spiked. Linear regression analysis is listed below. Results of singlicate measurements are listed below.

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| | Finger | Palm | Forearm | Upper arm |
| --- | --- | --- | --- | --- |
| Slope | 1.0447 | 1.0269 | 1.0282 | 1.0373 |
| y-intercept | -0.2241 | 1.2776 | 1.2533 | -0.1094 |
| R | 0.9952 | 0.9974 | 0.9975 | 0.9977 |
| SD GlucoNavii Mentor NFC meter | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Glucose concentration <75mg/dL | | | | Glucose Concentration ≥75mg/dL | | | |
| Site | Within ±5mg/dL | Within ±10mg/dL | Within ±15mg/dL | Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| Finger | 19/32 | 28/32 | 31/32 | 109/188 | 156/188 | 179/188 | 186/188 |
| | 59.4% | 87.5% | 96.9% | 58.0% | 83.0% | 95.2% | 98.9% |
| Palm | 8/16 | 16/16 | 16/16 | 51/84 | 70/84 | 81/84 | 84/84 |
| | 50.0% | 100% | 100% | 60.7% | 83.3% | 96.4% | 100% |
| Forearm | 9/16 | 16/16 | 16/16 | 51/84 | 68/84 | 81/84 | 84/84 |
| | 56.3% | 100% | 100% | 60.7% | 81.0% | 96.4% | 100% |
| Upper arm | 9/16 | 16/16 | 16/16 | 51/84 | 68/84 | 80/84 | 84/84 |
| | 56.3% | 100% | 100% | 60.7% | 81.0% | 95.2% | 100% |

b. Matrix comparison:

Not applicable

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

b. Clinical specificity:

Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):

User Performance Study:

Evaluation of the use of the device in the hands of the intended users was conducted using only English speaking and reading participants. A total of 311 total subjects participated in these studies. Three different test strip lots were used to evaluate the accuracy between results obtained from the fingertip and alternative sites using SD GlucoNavii Mentor NFC BGMS to the YSI results. Each participant was given the Instructions for use guide, control solution and check strip. Each participant performed calibration and quality control procedures using the control solution and check strip without assistance by healthcare professionals. After each procedure, the subjects were asked to answer the questionnaire evaluating their understanding of the

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procedures. Each subject collected and tested a fingerstick and 3 AST (palm, forearm, upper arm) samples using the NFC meter. After self-testing, the healthcare professional collected blood from the same participant's finger capillary and measured the blood glucose using both YSI and SD GlucoNavii Mentor NFC meter. The range of glucose values for the finger stick samples was $67.8 - 425\mathrm{mg / dL}$ measured by YSI. Results are summarized below:

All SD GlucoNavii Mentor NFC meter results vs. Reference

| | Tested by Professional (finger) | Tested by lay-user | | | |
| --- | --- | --- | --- | --- | --- |
| | | Finger | Palm | Forearm | Upper arm |
| Slope | 1.0923 | 1.0118 | 1.0632 | 1.0804 | 1.0596 |
| y-intercept | -7.1251 | 3.2445 | -2.7436 | -4.2085 | -2.5655 |
| R | 0.9855 | 0.9873 | 0.9803 | 0.9836 | 0.9899 |

For glucose concentrations $&lt; 75\mathrm{mg / dL}$

| Sample site | Within ±5mg/dL | Within ±10mg/dL | Within ±15mg/dL |
| --- | --- | --- | --- |
| Finger | 8/13 | 13/13 | 13/13 |
| | 61.5% | 100% | 100% |
| Palm | 4/13 | 12/13 | 13/13 |
| | 30.8% | 92.3% | 100% |
| Forearm | 7/13 | 13/13 | 13/13 |
| | 53.8% | 100% | 100% |
| Upper Arm | 7/13 | 13/13 | 13/13 |
| | 53.8% | 100% | 100% |

For glucose concentrations $\geq 75\mathrm{mg / dL}$

| Sample site | Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| --- | --- | --- | --- | --- |
| Finger | 153/298 | 248/298 | 285/298 | 296/298 |
| | 51.3% | 83.2% | 95.6% | 99.3% |
| Palm | 149/298 | 221/298 | 269/298 | 290/298 |
| | 50% | 74.2% | 90.3% | 97.3% |
| Forearm | 148/298 | 227/298 | 271/298 | 287/298 |
| | 49.7% | 76.2% | 90.9% | 96.3% |
| Upper arm | 154/298 | 245/298 | 287/298 | 298/298 |
| | 51.7% | 82.2% | 96.3% | 100% |

# 4. Clinical cut-off:

Not applicable

# 5. Expected values/Reference range:

The fasting adult blood glucose range for a person without diabetes $^1$ :

Before meals $&lt; 100 \mathrm{mg} / \mathrm{dL}$
After meals $&lt; 140\mathrm{mg / dL}$

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American Diabetes Association: Diabetes Care, 2015;38(Suppl. 1):S8-S16

## N. Instrument Name:
SD GlucoNavii® Mentor NFC blood glucose meter
SD GlucoNavii® Mentor NFC Multi blood glucose meter

## O. System Descriptions:

1. **Modes of Operation:**
Each test strip is single use and must be replaced with a new strip for additional readings. The minimal sample volume is 0.3μL.

Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?
☑ Yes ☐ X or No

Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?
☑ Yes ☐ X or No

2. **Software:**
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
☑ Yes ☐ X or No

3. **Specimen Identification:**
There is no sample identification function with this device. Samples are applied directly to the test strip as they are collected.

4. **Specimen Sampling and Handling:**
The device is intended to be used with capillary whole blood from the finger, palm, forearm and upper arm. The whole blood sample is applied directly to the test strip by capillary action therefore there are no special handling or storage issues.

5. **Calibration:**
This is non-coding device therefore no calibration is required by the user.

6. **Quality Control:**
Each kit comes with SD Glucose Control Solution Level M. The control solution is used to check that the meter and test strips are working together as a system and that the user is performing the test correctly. Control solution tests should be performed when a new box of test strips is opened, the test strip container is left open or the test strips are

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damaged, if the strips are left in extreme temperature or humidity, if the patient wants to check the meter and test strips, whenever the meter is dropped, whenever a result does not agree with the level felt by the patient or the patient wants to check if they are testing correctly.

Each system contains a SD Glucose check strip which is used to check the performance of the meter, before using the meter for the first time, whenever a result does not agree with the level felt by the patient or if the patient has repeated a test and the blood glucose result is still lower or higher than expected.

## P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:

1. Altitude study: An altitude study was performed at the following 4 different altitudes: 328 feet (100m), 3280 feet (1000m), 6561 feet (2000m) and 11,351 feet (3460m) with venous blood samples with glucose concentrations ranging from 43mg/dL to 352mg/dL. Each sample was tested in duplicate with 5 meters and one test strip lot and the results were compared to YSI. The results demonstrate acceptable bias to the reference to support the claims in the labeling that altitudes up to 11,351 feet have no significant effect on blood glucose measurements from the GlucoNavii Mentor NFC Monitoring System.

2. Hematocrit study: The effect of different hematocrit levels were evaluated using venous whole blood samples with hematocrit levels of 15-65% (15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65%) spiked with three levels of glucose concentrations (60, 150, 350mg/dL). The samples were tested with 10 meters and three lots of test strips. The results were compared to YSI and the normal 40% hematocrit. The percent bias of the GlucoNavii Mentor NFC meters results relative to YSI demonstrated adequate performance to support the claimed hematocrit range of 20-60%.

3. Infection control studies: The SD GlucoNavii Mentor NFC meter is intended for single patient use and the SD GlucoNavii Mentor NFC multi meter is intended for multiple patient use. Disinfection efficacy studies were performed on the materials comprising the meter by an outside commercial laboratory testing service to demonstrate complete inactivation of hepatitis B virus (HBV) with DisCide Ultra Disinfecting Towelettes (EPA Reg. No. 10492-4). Robustness studies were performed by the sponsor demonstrating that there was no change in performance or external materials of the meter after 10,950 cleaning and 10,950 disinfection cycles with DisCide Ultra Disinfecting Towelettes. The robustness studies were designed to simulate 3 years of multiple-patient use and 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

4. Sample Volume: A sample volume study was performed using five venous whole blood samples ranging from 58-240mg/dL to evaluate effect of different sample volumes (0.1μL, 0.2μL, 0.3μL, 0.4μL, 0.5μL, 0.6μL, 0.8μL, 1.0μL) on the performance of the

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device. Results at each sample volume were compared to the corresponding YSI values. Two lots of test strips and 10 meters were used. Results from these studies support the claimed sample volume of 0.3μL. The meter displays error message E-2 when an insufficient amount of blood sample is applied. This error message feature has been validated.

5. Operating Temperature and Humidity: Temperature and humidity operating conditions were evaluated using 6 SD GlucoNavii Mentor NFC meters and three lots of test strips with venous whole blood samples at three glucose concentrations (49.3mg/dL, 110.3mg/dL and 312mg/dL). The meters were exposed to the following temperature and humidity ranges 50°F/15%RH, 50°F/95%RH, 80°F/15%RH, 80°F/95%RH, 113°F/15% and 113°F/95%RH. Protocol and acceptance criteria were provided and found to be acceptable. The results supported the sponsor's claimed operating temperature from 50°F to 104°F and relative humidity range from 15% - 95%.

6. Risk Management: The sponsor states that they followed the requirements in ISO14971:2003 and ISO14971:2007 to assess the risk of their device

7. EMC testing and Electrical Safety Studies: The sponsor provided documentation certifying that acceptable electromagnetic testing (EMC) had been performed and the GlucoNavii Mentor NFC and GlucoNavii Mentor NFC Multi were found to be in compliance.

8. Readability Assessment: A Flesch-Kinkaid reading level assessment was conducted of the SD GlucoNavii Mentor NFC Blood Glucose Monitoring System User instruction guide, giving a readability grade level of 7.5.

A Flesch-Kinkaid reading level assessment was conducted of the SD GlucoNavii Mentor NFC Multi Blood Glucose Monitoring System User instruction guide, giving a readability grade level of 7.9.

A Flesch-Kinkaid reading level assessment was conducted of the SD GlucoNavii Mentor NFC Blood Glucose Test Strip Package Insert, giving a readability grade level of 6.2.

A Flesch-Kinkaid reading level assessment was conducted of the SD GlucoNavii Mentor NFC Multi Blood Glucose Test Strip Package Insert, giving a readability grade level of 6.9.

A Flesch-Kinkaid reading level assessment was conducted of the SD Glucose Control Solution Package Insert, giving a readability grade level of 6.9.

Q. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

R. Conclusion:

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1. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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