I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM

K132663 · Alliance International Co., Ltd. · NBW · Apr 20, 2015 · Clinical Chemistry

Device Facts

• Record ID: K132663
• Device Name: I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Alliance International Co., Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The i-QARE DS-W Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The i-QARE DS-W Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The i-QARE DS-W 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 i-QARE DS-W Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The i-QARE DS-W Draw-in Blood Glucose Test Strips are for use with the i-QARE DS-W Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

Device Story

The i-QARE DS-W is a portable blood glucose monitoring system for home use by patients with diabetes. It utilizes an electrochemical biosensor with carbon electrodes to measure glucose levels in fresh capillary whole blood. The user applies a 0.7 µL blood sample to a test strip, which uses capillary action to draw the sample into an internal chamber. The meter processes the electrochemical signal and displays the glucose concentration within 6 seconds. The device is operated by a single button and features a code-card-free design to simplify usage and reduce user error. It stores up to 20 test results for patient review. The system provides patients with a convenient, point-of-care method to monitor diabetes control, aiding in the management of their condition. It is not intended for use in critically ill patients or for diagnostic screening.

Clinical Evidence

User performance study with 150 lay users comparing capillary blood measurements (fingertip, palm, forearm) to YSI reference method. Results showed high accuracy: for glucose ≥ 75 mg/dL, 100% of results were within ±15% of reference across all sites. Bench testing included precision (CV < 6.0%), linearity (R² > 0.99), interference testing, and environmental robustness (altitude, temperature, humidity).

Technological Characteristics

Electrochemical biosensor with carbon electrodes. Powered by one 3V Lithium CR 2032 battery. Dimensions: 47.5mm x 76.5mm x 21.9mm; Weight: 46g (excluding battery). Features code-card-free operation and one-button interface. Sample volume: 0.7 µL. Hematocrit range: 20-60%.

Indications for Use

Indicated for quantitative blood glucose measurement in fresh capillary whole blood from fingertips, forearm, or palm. For single-patient, home-use, in vitro diagnostic monitoring of diabetes control. Not for neonatal use, diabetes screening, or diagnosis. Contraindicated for critically ill patients, those in shock, dehydrated, or hyper-osmolar states.

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

• DS-A Blood Glucose Monitoring System (K082965)

Submission Summary (Full Text)

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

A. 510(k) Number:
k132663

B. Purpose for Submission:
New device

C. Measurand:
Capillary whole blood glucose from the fingertip, palm, and forearm

D. Type of Test:
Quantitative Amperometric assay (FAD-Glucose oxidase)

E. Applicant:
Alliance International Co., Ltd.

F. Proprietary and Established Names:
i-QARE DS-W Blood Glucose Monitoring System

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1345, Glucose test system
2. Classification:
Class II
3. Product code:
NBW, System, Test, Blood Glucose, Over The Counter
CGA, Glucose Oxidase, Glucose
4. Panel:
Clinical Chemistry (75)

H. Intended Use:
1. Intended use(s):
See indication(s) for use below.
2. Indication(s) for use:
The i-QARE DS-W Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The i-QARE DS-W Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

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The i-QARE DS-W 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 i-QARE DS-W Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The i-QARE DS-W Draw-in Blood Glucose Test Strip is for use with the i-QARE DS-W Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

3. Special conditions for use statement(s):
- For over-the-counter use
- In vitro diagnostic use only
- Not for screening or diagnosis of diabetes mellitus
- This system should not be used on persons who are in shock, are dehydrated, or who are hyper-osmolar.
- Alternative site testing (AST) testing should only be done during steady-state times (when glucose is not changing rapidly).
- AST should not be used to calibrate continuous glucose monitors (CGMs)
- AST should not be used for insulin dose calculations
- Not for neonatal use
- Testing should be performed at altitudes under 8563 feet (2610 meters) since altitudes above this have not been evaluated.
- For single-patient use only
- This system is not for use in the critically ill

4. Special instrument requirements:
i-QARE DS-W Blood Glucose meter

I. Device Description:

The i-QARE DS-W Blood Glucose Monitoring System consists of the DS-W Blood Glucose Meter, DS-W Blood Glucose Test Strips (sold separately), Alliance Blood Glucose Control Solutions (Level 1, and Level 2; previously cleared in k082965; sold separately), lancing device, lancets (sold separately), 3V CR2032 Battery, Carrying Case, User's Manual, Test Strip insert, and control solution instructions.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Alliance International Co., Ltd. DS-A Blood Glucose Monitoring System

2. Predicate 510(k) number(s):
k082965

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3. Comparison with predicate:

| Similarities of the Blood Glucose System | | |
| --- | --- | --- |
| Item | Predicate Device Alliance International Co., Ltd. DS-A Blood Glucose Monitoring System (k082965) | Candidate Device Alliance International Co., Ltd. i-QARE DS-W Blood Glucose Monitoring System |
| Intended Use/Indications for Use | It is intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. | Same |
| Detection method | Amperometry | Same |
| Enzyme | Glucose Oxidase | Same |
| Test range | 20 - 600 mg/dL | Same |
| Sample type | Capillary whole blood | Same |
| Sample test time | 6 seconds | Same |
| Battery | One 3V Lithium CR 2032 battery | Same |
| Altitude | Up to 8563 feet (2610 meters) | Same |
| Differences of the Blood Glucose System | | |
| --- | --- | --- |
| Item | Predicate Device Alliance International Co., Ltd. DS-A Blood Glucose Monitoring System (k082965) | Candidate Device Alliance International Co., Ltd. i-QARE DS-W Blood Glucose Monitoring System |
| Setting | Single patient use | Single patient use |
| Sample volume | 1μL | 0.7μL |
| Sample sites | Fingertip, forearm, palm | Fingertip, forearm, and palm |
| Memory | 360 results | 20 results |
| Hematocrit range | 30 – 55% | 20 – 60% |
| Meter Weight | 56 g | 46 g |
| Meter Dimensions | 94.5mm x 56mm x 27.5mm | 47.5mm x76.5 mm x 21.9mm |
| Calibration Coding | Coding (code card) | Non-Coding |

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

- IEC 60601-1-2, Medical electrical equipment Part 1-2: General Requirements for Safety-Collateral Standard: Electromagnetic Compatibility- Requirements and tests, 2007
- IEC 60601-1, Medical Electrical Equipment-Part 1: General Requirements for Safety, 2005
- IEC/EN 61010-1: Medical electrical equipment Part 1. General requirements for safety, 2001
- IEC 61010-2-101: Safety particular requirements for IVD medical equipment, 2002.
- IEC 60068-2-64 Environment Testing Part 2: Test Method: Vibration, broad-band random and guidance, 1993.
- CLSI EP5-A: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-2nd edition, 1999.
- CLSI EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach, 2003
- CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline-2nd edition, 2005.

L. Test Principle:

The i-QARE DS-W Blood Glucose Monitoring System uses electrochemical methodologies. The system quantitatively measures blood glucose levels using an amperometric method. The system employs glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

The sponsor performed repeatability (with-in run precision) studies using venous whole blood samples at five glucose concentrations (target values 40, 80, 120, 200, and 300 mg/dL) using 10 meters. Each glucose concentration was analyzed in replicates of 40 for each of three strip lots resulting in a total of 120 measurements per concentration. Results are summarized below:

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| Repeatability precision (whole blood) | | | | | |
| --- | --- | --- | --- | --- | --- |
| Strip Lot | Target Glucose Concentration (mg/dL) | n | Mean (mg/dL) | SD (mg/dL) | CV (%) |
| Lot 1 | 40 | 40 | 41 | 2.0 | 4.9 |
| | 100 | 40 | 100 | 2.2 | 2.2 |
| | 200 | 40 | 201 | 3.1 | 1.5 |
| | 300 | 40 | 304 | 4.3 | 1.4 |
| | 400 | 40 | 403 | 4.3 | 1.1 |
| Lot 2 | 40 | 40 | 41 | 1.8 | 4.4 |
| | 100 | 40 | 100 | 2.1 | 2.0 |
| | 200 | 40 | 201 | 3.5 | 1.7 |
| | 300 | 40 | 303 | 4.3 | 1.4 |
| | 400 | 40 | 402 | 4.6 | 1.1 |
| Lot 3 | 40 | 40 | 42 | 2.5 | 6.0 |
| | 100 | 40 | 101 | 2.1 | 2.1 |
| | 200 | 40 | 201 | 3.5 | 1.7 |
| | 300 | 40 | 303 | 3.8 | 1.2 |
| | 400 | 40 | 403 | 5.4 | 1.3 |

Intermediate precision was evaluated by using three levels of glucose control solutions with target concentrations of 80, 130, and 320 mg/dL. Each sample was measured twenty times per day over ten days using the DS-W Blood Glucose Meter, for a total of 200 tests per glucose level. This procedure was followed for each of three strip lots.

Results are summarized below:

Lot 1

| Glucose Target Conc (mg/dL) | Number of tests | Mean (mg/dL) | SD (mg/dL) | % CV |
| --- | --- | --- | --- | --- |
| 80 | 200 | 82.8 | 2.3 | 2.81 |
| 130 | 200 | 132.1 | 2.9 | 2.21 |
| 320 | 200 | 321.6 | 5.9 | 1.83 |

Lot 2

| Glucose Target Conc (mg/dL) | Number of tests | Mean (mg/dL) | SD (mg/dL) | % CV |
| --- | --- | --- | --- | --- |
| 80 | 200 | 83.2 | 2.3 | 2.75 |
| 130 | 200 | 131.9 | 2.8 | 2.13 |
| 320 | 200 | 322.8 | 6.0 | 1.86 |

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Lot 3

| Glucose Target Conc (mg/dL) | Number of tests | Mean (mg/dL) | SD (mg/dL) | % CV |
| --- | --- | --- | --- | --- |
| 80 | 200 | 83.0 | 2.1 | 2.53 |
| 130 | 200 | 132.2 | 2.6 | 2.00 |
| 320 | 200 | 321.8 | 6.6 | 2.05 |

b. Linearity/assay reportable range:

The sponsor performed linearity studies using adjusted venous blood samples with eight different glucose concentrations (as measured by YSI) of 17, 45, 101, 149, 245, 328, 538, and 603 mg/dL. For each glucose concentration, twenty-one measurements were made per strip lot, for each of 3 test strip lots. The data from the DS-W Blood Glucose Monitoring System was compared to the reference method (YSI). Results from linear regression analyses were as follows:

| Strip Lot | Slope | y-intercept | R² |
| --- | --- | --- | --- |
| Lot #1 | 1.0078 | 0.1256 | 0.9989 |
| Lot #2 | 1.0053 | 1.6559 | 0.9995 |
| Lot #3 | 0.998 | 2.2109 | 0.9993 |

The results of this study support the sponsor's claimed glucose measuring range of 20 - 600 mg/dL. Results less than 20 mg/dL will be displayed as LO, and results greater than 600 mg/dL will be displayed as HI.

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

Traceability:

The i-QARE DS-W Blood Glucose Monitoring System is traceable to the NIST SRM 917b reference material. The method comparison study was performed using the candidate device and YSI as the reference method (see Section 2.a.).

Test Strip Stability:

Test strip stability was assessed in accelerated and real time studies. Testing protocols and acceptance criteria for the i-QARE DS-W Draw-in Blood Glucose Test Strips were reviewed and found to be acceptable. The sponsor claims shelf life stability of 18 months and an open-vial stability of 90 days when stored as recommended: 39.2°F-89.6°F (4°C - 32°C) and 10-90% relative humidity.

Control Solution Stability:

The Alliance Blood Glucose Control Solutions that are used with the i-QARE DS-W Blood Glucose Monitoring System were previously cleared under k082965. The closed-vial stability claim for the control solutions is 18 months when stored at

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73.4°F-80.6°F (23°C to 27°C). The opened-vial stability claim for the control solutions is 90 days from first opening when stored at 68°F-86°F (20°C to 30°C).

d. Detection limit:
The measuring range for this device is 20 – 600 mg/dL. Please refer to the linearity study in section M.1.b. above.

e. Analytical specificity:
To assess potential interference the sponsor used venous whole blood samples adjusted to two glucose concentration intervals of 70 to 75 mg/dL and 200 to 250 mg/dL. Each of these samples was divided into a test pool and a control pool and each of the potential endogenous and exogenous interfering substances was added to the test pool. Each substance was tested at a minimum of two concentrations, normal/therapeutic and high/toxic concentrations. The % difference between the test sample and the control sample was calculated. The sponsor defines no significant interference as ≤ ± 10 % difference for each individual replicate relative to the control sample. Results are presented in the table below:

| Potential Interfering Substance | Highest concentration at which no significant interference was observed (mg/dL) |
| --- | --- |
| Acetaminophen | 20 |
| Ascorbic Acid | 4.7 |
| Bilirubin | 20 |
| Cholesterol | 500 |
| Creatinine | 1.5 |
| Dopamine | 0.02 |
| Galactose | 1500 |
| Gentisic acid | 4 |
| Hemoglobin | 500 |
| Ibuprofen | 4.4 |
| L-Dopa | 0.712 |
| Maltose | 1000 |
| Methyldopa | 0.9 |
| Tetracycline | 0.4 |
| Tolbutamide | 100 |
| Tolazamide | 10 |
| Triglycerides | 1900 |
| Uric Acid | 6 |
| Xylose | 20 |

The sponsor has the following limitations in their labeling:

The following substances may cause interference at levels above the following concentrations:

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Dopamine - 0.02 mg/dL

L-Dopa - 0.712 mg/dL

Methyldopa - 0.9 mg/dL

Uric Acid - 6 mg/dL

Triglycerides - 1900 mg/dL

Ascorbic Acid - 4.7 mg/dL

Acetaminophen - 20 mg/dL

Cholesterol - 500 mg/dL

Do not use the i-QARE DS-W Blood Glucose Monitoring System during or within 24 hours of receiving a D-xylose absorption test as this may cause inaccurately high results.

f. Assay cut-off:

Not applicable.

2. Comparison studies:

a. Method comparison with predicate device:

System Accuracy:

To assess system accuracy, results from the DS-W Blood Glucose Meter were compared to a reference method (YSI 2300 STAT PLUS). Healthcare professionals tested 178 capillary samples from fingertip, palm and forearm, ranging in glucose concentration from 40 to 493 mg/dL (according to YSI), using 10 meters. The results relative to YSI are summarized in the tables below:

For glucose concentrations &lt; 75 mg/dL

| Sample Site | Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL |
| --- | --- | --- | --- |
| Finger | 23/27 (85.2%) | 25/27 (92.6%) | 27/27 (100%) |
| Palm | 20/27 (74.1%) | 27/27 (100%) | 27/27 (100%) |
| Forearm | 21/27 (77.8%) | 26/27 (96.3%) | 27/27 (100%) |

For glucose concentrations ≥ 75 mg/dL

| Sample Site | Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| --- | --- | --- | --- | --- |
| Finger | 117/151 (77.5%) | 145/151 (96.03%) | 151/151 (100%) | 151/151 (100%) |

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| Palm | 123/151(81.5%) | 144/151(95.4%) | 151/151(100%) | 151/151(100%) |
| --- | --- | --- | --- | --- |
| Forearm | 109/151(72.2%) | 138/151(91.4%) | 151/151(100%) | 151/151(100%) |

Linear Regression Analysis:

Finger: $0.9985\mathrm{x} + 0.4766$ . $\mathbf{R}^2 = 0.9946$

Palm: $y = 0.9859x + 0.0.6471$ ; $R^2 = 0.9943$

Forearm: $y = y = 0.9838x - 2.1937$ ; $R^2 = 0.9937$

b. Matrix comparison:

Not applicable. This device is intended to be used with fresh capillary whole blood only.

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:

To assess the performance of the DS-W Blood Glucose Monitoring System in the hands of the intended users the sponsor performed a study with 150 lay user participants who collected 150 samples each from the fingertip, palm, and forearm. Results were analyzed by comparing glucose measurements from capillary blood samples obtained by untrained users using the DS-W Blood Glucose Meter to glucose measurements from capillary blood samples collected by a technician and measured using a laboratory reference method (YSI). The range of glucose values tested was $61 - 408\mathrm{mg / dL}$ as measured by YSI. Three test strip lots were tested in the study. The results are summarized in the tables below:

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

| Sample Site | Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL |
| --- | --- | --- | --- |
| Finger | 16/17 (94.1%) | 17/17 (100%) | 17/17 (100%) |
| Palm | 15/17 (88.2%) | 17/17 (100%) | 17/17 (100%) |
| Forearm | 16/17 (94.1%) | 17/17 (100%) | 17/17 (100%) |

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For glucose concentrations ≥ 75 mg/dL

| Sample Site | Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| --- | --- | --- | --- | --- |
| Finger | 112/133
(84.2%) | 132/133
(99.2%) | 133/133
(100%) | 133/133
(100%) |
| Palm | 109/133
(82.0%) | 128/133
(96.2%) | 133/133
(100%) | 133/133
(100%) |
| Forearm | 118/133
(88.7%) | 130/133
(97.7%) | 133/133
(100%) | 133/133
(100%) |

Linear Regression Analysis:
Finger: y = 1.0161x + 0.7253; R² = 0.9969
Palm: y = 1.0045x + 1.177; R² = 0.9957
Forearm: y = 1.0067x - 1.118; R² = 0.9966

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Expected blood glucose levels for people without diabetes

| Time | Range | Range |
| --- | --- | --- |
| Fasting | <100 mg/dL | <5.6 mmol/L |
| Two hours after meals | <140 mg/dL | <7.8 mmol/L |

American Diabetes Association: Standard of Medical Care in Diabetes 2014, Diabetes Care, vol.37, supplement 1, S14-S80, January 2014.

N. Instrument Name:
i-QARE DS-W Blood Glucose Meter

O. System Descriptions:
1. Modes of Operation:
Each test strip is single use and requires a sample volume of 0.7 μL
Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?
Yes ______ or No ☐ X

Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?

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Yes _______ or No ☐ X.

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 glucose test is intended to be used with capillary whole blood from the finger, forearm, or palm. The whole blood sample is applied directly to the test strip by capillary action.

5. Calibration:
Users are instructed to match the code number of the test strip to that displayed by the meter for each box of test strips.

6. Quality Control:
Glucose control solutions (previously cleared, k082965) at two different concentrations (Level 1 and Level 2) can be run with this device and Control Level 1 is provided with the kit. The meter automatically distinguishes control solution from blood and marks control solution tests with a check mark and excludes them from average calculations. Recommendations on when to test the control materials are provided in the labeling. An acceptable range for each control level is printed on the test strip bottle label. The user is cautioned not to use the meter if the control result falls outside these ranges.

P. Other Supportive Instrument Performance Characteristics Data Not Covered In the
“Performance Characteristics” Section above:

1. Altitude Study:
The effect of altitude on device performance was evaluated with one test strip lot and five meters using contrived venous blood samples from three donors. Samples were spiked to 5 glucose concentrations (50, 120, 200, 350, and 500 mg/dL). The samples were tested at 2543, 5446, 6529, and 8563 feet above sea level and at sea level (0 feet) as a control. Results obtained were compared with those obtained with the reference method (YSI). The results demonstrate acceptable bias to the reference to support the claims in the labeling that altitudes up to 8563 feet have no significant effect on blood glucose measurements from the DS-W Blood Glucose Monitoring System.

2. Hematocrit Study:
The effect of different hematocrit levels was evaluated using venous whole blood

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samples with hematocrit levels of 20 – 60% (20, 25, 30, 35, 40, 45, 50, 55 and 60%) spiked with glucose to achieve concentrations of 50, 120, 250, and 500 mg/dL. Results of samples at each hematocrit level were compared to samples with the same glucose concentration at normal (40%) hematocrit as well as to the corresponding YSI value. The % bias of the i-QARE DS-W Blood Glucose meter results relative to YSI demonstrated adequate performance to support the claimed hematocrit range of 20 – 60%.

## 3. Test System operating conditions:

The sponsor evaluated the effect of temperature and relative humidity (RH) on the performance of the DS-W Blood Glucose Monitoring System using venous blood samples at 50, 250, and 500 mg/dL glucose. The following combined temperature and humidity conditions were evaluated and compared with results obtained with the YSI reference method: 14°, 18°, 22°, 25°, 28°, 32°, 36°, and 40°C at relative humidities of 10, 40, 65, and 95%. The study results support the claimed operating temperature range of 57°F to 104°F (14°C to 40°C) with relative humidity of 10 – 95%.

## 4. EMC Testing:

The sponsor provided documentation certifying that acceptable electromagnetic testing (EMC) had been performed.

## 5. Readability Assessment:

The readability of the labeling (Owner’s Booklet, Control Solution Insert, and Test Strip Insert) using a Flesch-Kincaid analysis were found to be written at an 8th grade level or below.

## 6. Software documentation:

The software documentation was reviewed and found to be acceptable. The firm provided documentation to support the device was designed, developed and is under good software lifecycle processes.

## 7. Infection Control Studies:

The device system is intended for single-patient use only. Disinfection efficacy studies were performed on the materials comprising the meter by an outside commercial testing laboratory demonstrating complete inactivation of Hepatitis B Surface Antigen (HBsAg) with the chosen disinfectant, Dispatch Hospital Cleaner Disinfectant with Bleach (EPA Registration # 56392-8). Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials of the meter after 260 cleaning and disinfection cycles with the Dispatch wipes. The robustness studies were designed to simulate 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

## Q. Proposed Labeling:

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

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R. Conclusion:

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

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