IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM

K133584 · Eoshealth, Inc. · CGA · Sep 8, 2014 · Clinical Chemistry

Device Facts

• Record ID: K133584
• Device Name: IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Eoshealth, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Sep 8, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The In Touch® Blood Glucose Monitoring System (In Touch® BGMS) is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in fresh whole capillary blood from the fingertip. It is intended for use by people with diabetes mellitus at home as an aid to monitor the effectiveness of diabetes control program. The In Touch® BGMS is for in vitro diagnostic use only and should not be used for the diagnosis of /or screening for diabetes mellitus or neonatal use. The In Touch® BGMS is intended to be used by a single person and should not be shared. The In Touch® Blood Glucose Test Strips (In Touch® strips) are used with the In Touch® Blood Glucose Meter (In Touch® meter) in the quantitative measurement of glucose in fresh capillary blood from the fingertip. The In Touch® Control Solution is for use with the In Touch® strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.

Device Story

In Touch BGMS measures glucose in capillary whole blood via electrochemical biosensor technology; uses disposable test strips; capillary action draws 0.8 uL sample into strip; glucose reacts with reagent; meter measures resulting electrical current (amperometry); displays quantitative glucose level. Used at home by patients with diabetes; single-person use. Includes meter, test strips, lancing device, control solutions. Meter features color touch LCD, pedometer, 500-result memory, 7-90 day averaging. Provides immediate feedback to patient for diabetes management. No user calibration required; meter automatically codes. Control solutions verify system function; meter algorithm distinguishes control solution from patient samples to prevent storage of control results in patient memory.

Clinical Evidence

Lay user study (N=102) evaluated accuracy of self-testing on fingertip samples compared to YSI reference method. Results: 100% of samples within ±20% of reference for glucose ≥75 mg/dL; 100% within ±15 mg/dL for glucose <75 mg/dL. Regression analysis showed R²=0.9882. Bench testing included precision (CV 1.9-4.6%), linearity (20-600 mg/dL), interference studies, hematocrit (20-70%), altitude (up to 8,516 ft), and temperature/humidity stability.

Technological Characteristics

Electrochemical biosensor; glucose oxidase reagent; amperometric detection. Dimensions: 91.4 x 58.4 x 22.9 mm; weight 75g. Power: 3.7V 1100 mAh rechargeable Li-Polymer battery. Color touch LCD. Connectivity: USB. Standards: ISO 10993-1, ISO 14971, IEC 61010-1/2-101, IEC 61326-1, BS EN 62304.

Indications for Use

Indicated for persons with diabetes mellitus (adults and children) for quantitative measurement of glucose in fresh whole capillary blood from the fingertip in home settings to monitor diabetes control program effectiveness. Not for diagnosis/screening of diabetes or neonatal use. Single-patient use only.

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

• On Call® Vivid Blood Glucose Monitoring System (k112653)
• On Call® Diabetes Management Software (k101371)

Submission Summary (Full Text)

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

A. 510(k) Number:
k133584

B. Purpose for Submission:
New Device

C. Measurand:
Capillary whole blood glucose

D. Type of Test:
Quantitative, Amperometric method, Glucose oxidase

E. Applicant:
EosHealth, Inc.

F. Proprietary and Established Names:
In Touch Blood Glucose Monitoring System

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1345, Glucose Test System
21 CFR 862.1660, Quality Control Material (assayed and unassayed)
2. Classification:
Class II
Class I, reserved

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3. Product Code:
NBW, System, Test, Blood Glucose, Over the Counter
CGA, Glucose Oxidase, Glucose
JJX, Quality Control Material (Assayed and Unassayed)

4. Panel:
Clinical Chemistry (75)

H. Intended Use:

1. Intended use(s):
See Indications for Use below.

2. Indication(s) for use:
The In Touch Blood Glucose Monitoring System (In Touch BGMS) is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in fresh whole capillary blood from the fingertip. It is intended for use by people with diabetes mellitus at home as an aid to monitor the effectiveness of a diabetes control program. The In Touch BGMS is for in vitro diagnostic use only and should not be used for the diagnosis of /or screening for diabetes mellitus or neonatal use. The In Touch BGMS is intended to be used by a single person and should not be shared.

The In Touch Blood Glucose Test Strips (In Touch strips) are used with the In Touch Blood Glucose Meter (In Touch meter) in the quantitative measurement of glucose in fresh capillary blood from the fingertip.

The In Touch Control Solution is for use with the In Touch meter and In Touch strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.

3. Special conditions for use statement(s):
For over the counter use
Not for use on neonates
Not for the diagnosis of or screening for diabetes mellitus
Not for use on critically ill patients, patients in shock, dehydrated patients or hyper-osmolar patients
For single person use and should not be shared

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4. Special instrument requirements:

The In Touch Blood Glucose Meter

I. Device Description:

The In Touch BGMS consists of the following components: In Touch Blood Glucose Meter, In Touch Blood Glucose Test Strips, In Touch Lancing Device, In Touch Lancets, In Touch Level 1 Control Solution, In Touch Level 2 Control Solution, AC Adapter (wall charger) and USB Charger, and Carrying Case.

The In Touch strips are packaged in two available configurations: a 25 count of individually sealed packages containing a single test strip, and a 50 count of strips in sealed vials.

The In Touch Control Solutions consist of an aqueous based mixture prepared with a known amount of glucose concentration. It is available in two levels, Level 1 and Level 2.

J. Substantial Equivalence Information:

1. Predicate device name(s):

ACON Laboratories, Inc. On Call Vivid Blood Glucose Monitoring System

2. Predicate 510(k) number(s)

k112653

3. Comparison with predicate:

| Similarities of the Blood Glucose System | | |
| --- | --- | --- |
| Item | On Call Vivid Blood Glucose Monitoring System (Predicate Device) k112653 | In Touch Blood Glucose Monitoring System (Candidate Device) k133584 |
| Intended Use/Indications for Use | For the quantitative measurement of glucose as an aid to monitor the effectiveness of diabetes control in people with diabetes. | Same |
| Test Principle | Electrochemical enzymatic assay, Glucose Oxidase | Same |
| Sample Type | Fresh capillary whole blood | Same |
| Detection method | Amperometry | Same |
| Monitor Data Storage | 500 results with time and date | Same |
| Day average | 7-, 14-, 30-, 60-, 90- day average glucose result | Same |

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| Similarities of the Blood Glucose System | | |
| --- | --- | --- |
| Item | On Call Vivid Blood Glucose Monitoring System (Predicate Device) k112653 | In Touch Blood Glucose Monitoring System (Candidate Device) k133584 |
| Length of Test | 5 seconds | Same |
| Measurement range | 20 to 600 mg/dL | Same |
| Sample Volume | 0.8 u/L | Same |
| Hematocrit Range | 20% to 70% | Same |
| Meter Operating Temperature | 41°F to 113°F (5°C to 45°C) | Same |
| Meter Operating Relative Humidity | 10% to 90% non-condensing | Same |
| Operating Altitude | Up to 8516 ft. (2595 m) | Same |
| Test Strips Storage Temperature Range | 41°F to 86°F (5°C to 30°C) | Same |
| Calibration Coding | No Code | Same |
| Differences of the Blood Glucose System | | |
| --- | --- | --- |
| Item | On Call Vivid Blood Glucose Monitoring System (Predicate Device) k112653 | In Touch Blood Glucose Monitoring System (Candidate Device) k133584 |
| Sample Site | Fingertip, Forearm, Palm | Fingertip |
| Dimensions | 3.58" x 2.28" x 0.83" | 3.6 x 2.3 x 0.9 in (91.4 x 58.4 x 22.9 mm) |
| Weight | Approximately 60 g (without battery installed) | 2.65 oz. (75 g) |
| Battery Type | Two (2) CR 2032 3.0V coin cell batteries, 250 mA | 3.7 Li-Polymer Battery 1100 mAh, rechargeable in 2 hours, permanently installed |
| Display | B & W LCD | Color LCD-Touch |
| Pedometer | No | Pedometer |
| Similarities of the Control Solution | | |
| --- | --- | --- |
| Item | On Call Vivid Blood Glucose Monitoring System (Predicate Device) k112653 | In Touch Blood Glucose Monitoring System (Candidate Device) k133584 |
| Intended Use/Indications for Use | To check that the glucose meter and test strips are working together properly and that the test is performing correctly. | Same |
| Matrix | Viscosity adjusted, aqueous liquid | Same |
| Number of levels | 2 | Same |

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

- ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
- ISO 14971:2007 Medical devices - Application for risk management to medical devices
- IEC 61326-1: Ed. 1.0 (2005-12) Electrical equipment for measurement, control and laboratory use - EMC requirements - Part I: General requirements
- IEC 61010-2-101: Ed 1.0 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-1 0I · Particular requirements for in vitro diagnostic (IVD) medical equipment
- IEC 61010-1: Ed. 3.0 (B2010) Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1: General requirements
- BS EN 62304: 2006 Medical device software - Software life cycle processes
- BS EN 62304: 2013 Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
- BS EN 62304: 2008-Ed.2.0 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
- IEC 61000-4-3: 2006-Ed.3.0/ Amd.l:2007 Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
- IEC 61000-4-8: Ed.2.0 2009 2009-Ed.2.0 Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test
- IEC 61000-4-8:2009-Ed.2.0 Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency
- CLSI/NCCLS EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; 2004

L. Test Principle:

The In Touch Blood Glucose Monitoring System test principle is based on electrochemical biosensor technology and the principle of capillary action. The electrical current generated by the reaction of glucose with the reagent of the strip is measured by the meter and is displayed as the corresponding blood glucose level. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. These blood glucose measurements are obtained through the use of disposable test strips.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Within-run precision was measured by using heparinized venous whole blood at five different glucose concentrations. Each sample was tested on 3 lots of test strips on

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10 meters. Ten replicates were tested per meter, test strip lot, and glucose concentration, (N=100 per glucose concentration tested). Results are summarized below:

| Glucose Level (mg/dL) | Strip Lot | Mean (mg/dL) | SD (mg/dL) | %CV |
| --- | --- | --- | --- | --- |
| 30 – 50 mg/dL | 1 | 47.1 | 1.62 | 3.4% |
| | 2 | 47.5 | 1.53 | 3.2% |
| | 3 | 47.7 | 2.17 | 4.6% |
| | Combined | 47.33 | 1.77 | 3.7% |
| 51 – 110 mg/dL | 1 | 76.3 | 2.83 | 3.7% |
| | 2 | 74.9 | 1.92 | 2.6% |
| | 3 | 75.9 | 2.37 | 3.1% |
| | Combined | 75.7 | 2.37 | 3.2% |
| 111 - 150 mg/dL | 1 | 131.1 | 4.36 | 3.3% |
| | 2 | 127.4 | 4.15 | 3.3% |
| | 3 | 129.6 | 4.43 | 3.4% |
| | Combined | 129.37 | 4.31 | 3.3% |
| 151 – 250 mg/dL | 1 | 209.4 | 7.11 | 3.4% |
| | 2 | 205.9 | 7.25 | 3.5% |
| | 3 | 207.8 | 7.07 | 3.4% |
| | Combined | 207.67 | 7.14 | 3.4% |
| 251 – 400 mg/dL | 1 | 321.9 | 11.74 | 3.6% |
| | 2 | 336.2 | 12.78 | 3.8% |
| | 3 | 321.8 | 9.44 | 2.9% |
| | Combined | 326.63 | 11.33 | 3.4% |

Intermediate precision was measured by reading three different control materials on 3 lots of test strips, using 10 test strips on 10 meters (1 strip per meter), over 10 days (N=100 per glucose concentration tested). Results are summarized below:

| Glucose Level (mg/dL) | Strip Lot | Mean (mg/dL) | SD (mg/dL) | % CV |
| --- | --- | --- | --- | --- |
| Level 1
30 - 50 | 1 | 37.1 | 1.35 | 3.6% |
| | 2 | 38.2 | 1.49 | 3.9% |
| | 3 | 37.1 | 1.50 | 4.1% |
| | Combined | 37.5 | 1.45 | 3.9% |
| Level 2
96 - 144 | 1 | 118.7 | 2.98 | 2.5% |
| | 2 | 121.5 | 3.72 | 3.1% |

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| | 3 | 116.8 | 3.12 | 2.7% |
| --- | --- | --- | --- | --- |
| | Combined | 119.0 | 3.27 | 2.8% |
| Level 3
280 - 420 | 1 | 357.4 | 6.71 | 1.9% |
| | 2 | 354.1 | 8.95 | 2.5% |
| | 3 | 338.5 | 8.61 | 2.5% |
| | Combined | 350.0 | 8.09 | 2.3% |

b. Linearity/assay reportable range:

The In Touch linearity study was designed following CLSI EP6-A guidelines. The linearity study was performed using heparinized venous whole blood at eleven different glucose concentrations. The eleven target levels were prepared with glucose stock solutions to achieve the following glucose concentrations;

10.46 mg/dL, 21.2 mg/dL, 43.2 mg/dL, 73.3 mg/dL, 100.2 mg/dL, 167.8 mg/dL, 215.2 mg/dL, 325.6 mg/dL, 455.5 mg/dL, 562.0 mg/dL and 672.9 mg/dL.

The values from the In Touch meter were compared with those obtained from the reference method. The results from linear regression analysis are summarized below:

| Strip Lot | Slope | Intercept | R2 |
| --- | --- | --- | --- |
| 1 | 0.9997 | 2.3576 | 0.9986 |
| 2 | 0.9962 | 0.1444 | 0.9986 |
| 3 | 1.0106 | -1.2049 | 0.9974 |

The results support the sponsor's claimed measurement range of 20-600 mg/dL. Data from bench studies and software verification studies were provided to demonstrate that if a sample is less than 20 mg/dL, the result is flagged by the meter as LO. If a sample result exceeds 600 mg/dL, the result is flagged by the meter as HI.

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

Traceability: In Touch Blood Glucose Monitoring System is traceable to the NIST SRM 917b reference material.

Stability: Unopened control solutions have a 24 month shelf life and are stable for 6 months after first opening when stored at 5-30°C (41-86°F). The unopened multi strip vial configuration has a 24 month shelf life and is stable for 6 months after opening when stored at 5-30°C (41-86°F) and relative humidity from 10 – 90%. The unopened single test strip configuration has a 24 month shelf life when stored at 5-30°C (41-86°F) and relative humidity from 10 – 90%.

d. Detection limit:

The reportable range for the In Touch Blood Glucose Monitoring System is 20-600 mg/dL. See linearity study above (section M.1.b.).

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# e. Analytical specificity:

The interference study was designed according to CLSI EP7-A2 guideline. Common endogenous and exogenous interference substances were evaluated by spiking venous whole blood (collected in tubes containing heparin) with three levels glucose concentrations (level 1: $40 - 60\mathrm{mg / dL}$ , Level 2: $80 - 120\mathrm{mg / dL}$ , Level 3: $300 - 400\mathrm{mg / dL}$ ). The glucose samples were spiked with the potentially interfering compounds and tested on 3 lots of test strips. Each glucose concentration was evaluated at a low and a high concentration of the interfering substances. Bias was calculated as the difference between the test and control concentration groups. The following tables show the test concentrations for each potential interfering substance:

| | | Test Concentration | |
| --- | --- | --- | --- |
| Endogenous Compounds | Therapeutic Level (mg/dL) | Low Concentration (mg/dL) | High Concentration (mg/dL) |
| Ascorbic Acid | 0.4 – 2.0 | 3 | 6 |
| Conjugated Bilirubin | <0.4 | 34 | 50 |
| Unconjugated Bilirubin | 0.3 – 1.3 | 20 | 40 |
| Cholesterol | 114 - 300 | 250 | 500 |
| Creatinine | 0.6 – 1.3 | 1.5 | 5 |
| Glutathione | 0.01 – 0.3 | 0.5 | 1 |
| Hemoglobin | 100 – 200 | 200 | 500 |
| Triglycerides | 150 - 500 | 1500 | 3000 |
| Urea | 6.6 – 85.8 | 260 | 600 |
| Uric Acid | 2.5 – 8.0 | 8 | 23.5 |
| | | Test Concentration | |
| --- | --- | --- | --- |
| Exogenous Substances | Therapeutic Level (mg/dL) | Low Concentration (mg/dL) | High Concentration (mg/dL) |
| Acetaminophen | 1.0 – 3.0 | 4 | 20 |
| Dopamine | 0.03 | 0.03 | 0.09 |
| Ephedrine | 0.001 | 0.1 | 0.5 |
| Ethanol | 100 – 200 | 200 | 400 |
| Gentisic Acid | 0.2 – 0.6 | 6 | 10 |
| Ibuprofen | 1.0 – 7.0 | 7 | 50 |
| Levodopa | 0.02 – 0.3 | 0.3 | 3 |
| Methyldopa | 0.1 – 0.75 | 0.75 | 1.5 |
| Salicylic Acid | 10 - 30 | 30 | 60 |
| Tetracycline | 0.2 – 0.5 | 0.5 | 1.5 |
| Tolazamide | 2.0 – 2.5 | 5.0 | 10 |
| Tolbutamide | 5.4 – 10.8 | 11 | 64 |

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| | | Test Concentration | |
| --- | --- | --- | --- |
| Sugar Alcohols | Therapeutic Level (mg/dL) | Low Concentration (mg/dL) | High Concentration (mg/dL) |
| Lactose | 0.5 | 5 | 25 |
| Fructose | 1 - 6 | 30 | 100 |
| Galactose | 4 - 80 | 78 | 100 |
| Maltose | 100 | 40 | 100 |
| Mannitol | 0.0128 | 300 | 600 |
| Sorbitol | 0.044 | 30 | 70 |
| Xylose | 20 - 40 | 90 | 200 |

The substances and levels tested above have &lt;10% bias except for ascorbic acid &gt; 3 mg/dL (above therapeutic levels). Ascorbic acid levels &gt; 3 mg/dL will interfere with the glucose reading; therefore, the following limitation is included in the labeling:

"Acetaminophen, uric acid, and ascorbic acid (vitamin C) (when occurring in blood at normal or high therapeutic concentration) do not significantly affect results. However, abnormally high concentration in blood may cause inaccurately high results.

f. Assay cut-off:

Not applicable.

2. Comparison studies:

a. Method comparison with predicate device:

See lay user study in M.3.c that supports device accuracy.

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):

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A lay user study was conducted with 102 participants who obtained and tested their own fingerstick samples. The participants read the User's Manual in English, performed testing on their finger. A technician also collected capillary blood for measurements on the comparator method after the lay user participants obtained and tested their samples. Samples in the study contained glucose concentrations that ranged from 48 to 391 mg/dL. Results are summarized below:

| Lay User Fingertip Site: System Accuracy Results for Glucose Concentration ≥75mg/dL | | | |
| --- | --- | --- | --- |
| Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| 68/93 (73.1%) | 87/93 (93.5%) | 92/93 (98.9%) | 93/93 (100.0%) |
| Lay User Fingertip Site: System Accuracy Results for Glucose Concentration <75mg/dL | | | |
| Within ± 5 mg/dL | Within ± 10 mg/dL | | Within ± 15 mg/dL |
| 6/9 (66.7%) | 9/9 (100.0%) | | 9/9 (100.0%) |

Regression study results: Lay user's fingerstick results compared to the YSI method:

| Linear Regression Results: In Touch® (y) vs. YSI Reference (x) Lay User | | | | | |
| --- | --- | --- | --- | --- | --- |
| Sample Site | Slope | Intercept | R | R2 | N |
| Fingertip | 0.9987 | 0.4456 | 0.9941 | 0.9882 | 102 |

Flesch-Kincaid readability assessment was conducted and the results demonstrated that the User Manual, test strip package insert and control solution package insert were written at the 8th grade level.

4. Clinical cut-off:

Not applicable.

5. Expected values/Reference range:

For people without diabetes:

Fasting and before meals: 70 - 100 mg/dL

2 hours after meal: &lt; 140 mg/dL

Standards of Medical Care in Diabetes – 2014, Diabetes Care -2014 v 37: S1 January 2014

N. Instrument Name:

In Touch Blood Glucose Meter

O. System Descriptions:

1. Modes of Operation:

Each test strip is single use and requires a sample volume of 0.8 uL.

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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 ☐

The applicant has provided documentation that indicates the device was designed and developed under good software life-cycle processes.

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. The whole blood sample is applied directly to the test strip by capillary action.

5. Calibration:

There is no calibration required for the In Touch meter by the user. The meter is automatically coded.

6. Quality Control:

Glucose control solutions at two different concentrations are available to be run with this device. The meter has an algorithm to automatically recognize the control solutions to prevent control results from being stored in the internal memory as patient results. Recommendations on when to test the control materials are provided in the labeling. The control solution readings are not included in the average of the patient results. An acceptable range for each control level is printed on the test strip vial label. The user is cautioned not to use the meter if the control result falls outside these ranges.

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

1. Hematocrit Study:
The sponsor performed hematocrit studies using 8 different hematocrit levels (20, 25, 29, 40, 50, 61, 66, and 71%) spiked with glucose to generate 4 blood glucose concentrations (50 mg/dL, 100 mg/dL, 275 mg/dL, and 525 mg/dL) at each hematocrit level. Each sample was measured in replicates of four on three test strip lots using 5 In Touch meters. Results were compared to YSI 2300 STAT Glucose Analyzer results. The result demonstrated adequate performance to support the claimed hematocrit range of 20 – 70%.

2. Temperature and Relative Humidity Study:
The sponsor performed an Operating Conditions study, using venous blood samples at concentrations of 50 mg/dL, 100 mg/dL, and 525 mg/dL on three test strip lots tested at 7 combined temperature and relative humidity conditions (5°C/10% RH, 21 °C/ 10% RH, 45 °C/10%, 5 °C/90% RH, 21 °C/ 90% RH, 45 °C/ 90% RH, and 21 °C/ 45% RH). Each sample was compared to the YSI reference method. The results demonstrate that accurate readings can be obtained after exposure to temperatures ranging from 5 - 45°C and relative humidity conditions ranging from 10 – 90%.

3. Infection control:
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 virus (HBV) with the chosen disinfectant, Dispatch Hospital Cleaner Disinfectant Towels with Bleach disposable wipes (EPA Reg. No. 56392-8). Robustness studies were performed by the sponsor demonstrating no change in performance or external materials of the meter after 1,825 times of cleaning and disinfection cycles, using Dispatch Hospital Cleaner Disinfectant Towels with Bleach disposable wipes, to simulate 5 years of use by lay users. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

4. Customer support is available 24 hours per day, 365 days per year by calling 1-800-945-4355.

5. Electromagnetic Compatibility:
The Sponsor provided documentation certifying that electromagnetic testing (EMC) had been performed. Testing was found to be adequate for the In Touch Blood Glucose meter.

6. Altitude Study:
This study was conducted at a single site to evaluate the effect of altitude. The tested glucose range (obtained using YSI reference method) was from 41.7 to 567 mg/dL at sea level and 35.7 to 525 mg/dL at 8,516 ft. above sea level. Fingerstick blood samples were collected and compared to the YSI analyzer reference value. Each test strip glucose value was compared to the YSI method and then analyzed as a percent bias. The glucose values

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obtained had acceptable biases to support the altitude claim of 8,516 feet.

7. Sample volume study:
A sample volume study was performed to demonstrate that 0.8μL of whole blood is sufficient volume for the blood glucose meter system. For this study, sample volumes ranging from 0.4μL – 1.0 μL were evaluated using three different lots of test strips. The blood glucose sample results collected were compared with glucose values obtained with the YSI reference method and supported the minimum sample volume claim of 0.8 μL.

Q. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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

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