POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM

K090653 · Arkray Factory USA, Inc. · NBW · Oct 9, 2009 · Clinical Chemistry

Device Facts

• Record ID: K090653
• Device Name: POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Arkray Factory USA, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The PocketChem EZ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and palms. Testing is done outside the body ( In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

Device Story

System consists of meter, test strips, and control solutions; uses biosensor technology for quantitative glucose measurement. Input: fresh capillary whole blood (fingertip/palm) applied to test strip. Principle: glucose oxidase (GOD) and Hexammineruthenium (III) chloride reaction; oxidation of Hexammineruthenium (II) chloride generates electric current proportional to glucose concentration. Meter converts current to glucose value. User codes meter via code chip per strip vial. Used at home by patients or in clinics by professionals. Output: digital glucose concentration display. Benefits: aids diabetes management; provides rapid (10s) monitoring. Quality control solutions verify accuracy.

Clinical Evidence

Clinical testing evaluated accuracy for finger stick and palm test sites. Bench testing included evaluation of interferences, linearity, linear range, hematocrit effects, altitude effects, control solution functionality, and analytical precision.

Technological Characteristics

Blood glucose monitoring system consisting of a meter, test strips, and control solutions. Utilizes electrochemical sensing principle for quantitative glucose measurement. Designed for capillary whole blood samples.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (fingertips/palms) for diabetes management. For home (OTC) or clinical use. Contraindicated for neonates and not for diabetes diagnosis or screening.

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

• Ferrara Meter (K063068)

Submission Summary (Full Text)

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

A. 510(k) Number:
k090653

B. Purpose for Submission:
New glucose test strips for previously marketed glucose meter

C. Measurand:
Whole blood glucose

D. Type of Test:
Whole blood glucose concentration through a quantitative amperometric assay (Glucose Oxidase)

E. Applicant:
ARKRAY USA

F. Proprietary and Established Names:
PocketChem EZ Blood Glucose Monitoring System
Assure Dose Control Solution

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1345, Blood 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 codes:
NBW, Blood Glucose Test System, Over-the-Counter
CGA, Glucose Oxidase, Glucose
JJX, Single (specified) analyte controls (assayed and unassayed)

4. Panel:
75 (Clinical Chemistry)

H. Intended Use:

1. Intended use(s):
Refer to indications for use below.

2. Indication(s) for use:

PocketChem EZ Blood Glucose Monitoring System:
The PocketChem EZ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and palms. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. The PocketChem EZ Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

PocketChem EZ Blood Glucose Meter:
The PocketChem EZ Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and palms. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. The PocketChem EZ Blood Glucose Meter is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

PocketChem EZ Blood Glucose Test Strips:
PocketChem EZ test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and palms when used with the PocketChem EZ Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use in home (over the counter [OTC]) by persons

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with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. The PocketChem EZ Blood Glucose Test Strips are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

Assure Dose Control:

For use with PocketChem EZ Blood Glucose Meter and PocketChem EZ Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Control solutions are available in two levels – Level 1 (Normal) and Level 2 (High).

3. Special conditions for use statement(s):

- Not intended for diagnosis of diabetes mellitus
- For in vitro diagnostic use only
- Not intended for use on neonates
- Not for use on critically ill patients, dehydrated patients, patients in shock, or hyperosmolar patients

4. Special instrument requirements:

PocketChem EZ Blood Glucose Meter

I. Device Description:

The PocketChem EZ Blood Glucose Monitoring System consists of a meter, test strips, and two levels of control solutions. It uses biosensor technology to produce a quantitative glucose concentration from whole blood samples from the fingertip. Users are instructed to code the meter using the supplied code chip when first used and with each new box of test strips.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Arkray, Inc. Ferrara Blood Glucose Monitoring System

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

k063068

3. Comparison with predicate:

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate - k063068 |
| Indications for use | Same | As an aid to monitor the effectiveness of diabetes control |
| Anatomical Sites | Same | Fingertip, Palm |
| Code Chip | Same | Required |
| Test Time | Same | 10 Seconds |
| Hematocrit Range | Same | 30 – 55% |
| Maximum Altitude | Same | 10,000 ft. |
| Operating Temperature Range | Same | 50° F to 104° F |
| Operating Humidity Range | Same | 20 – 80% |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate -k063068 |
| Enzyme and Associated Reagents | Glucose Oxidase (Aspergillus niger) and Hexammineruthenium (III) chloride | Glucose Oxidase (Aspergillus niger) |
| Double Dosing Capability | No | Yes |
| Minimum Sample Volume | 0.5 μL | 1.0 μL |

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

- CLSI EP-07-A2, Interference Testing in Clinical Chemistry, 2005
- CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Methods, 2003
- ISO 15197, In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus, 2003

# L. Test Principle:

The sample (whole blood) is drawn by capillary action at the tip of the test strip. Glucose in the sample reacts with glucose oxidase (GOD) and Hexammineruthenium (III) chloride in the test strip. This produces Hexammineruthenium (II) chloride. Hexammineruthenium (II) chloride is produced in proportion to the glucose concentration of the blood sample.

Oxidation of the Hexammineruthenium (II) chloride produces an electric current. The meter converts the current to the glucose concentration and displays it as the test result:

$\beta$ -D-glucose $^+$ Hexammineruthenium (III) chloride $\xrightarrow{\mathrm{GOD}}$

D-Glucono-δLactone + Hexammineruthenium (II) chloride

Hexammineruthenium (II) chloride $\rightarrow$ Hexammineruthenium (III) chloride + e-

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M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Testing was performed using fresh venous whole blood obtained from several non-diabetic volunteers and adjusted to a pO2 of 60 to 80 mm Hg and hematocrit of 42%. The whole blood was spiked to obtain 5 glucose concentrations ranging from 43 – 374 mg/dL.

Within-Day precision tests consisted of 10 measurements of each of the five spiked whole blood glucose samples using 10 meters for each sample for a total of 500 measurements. The within-run precision for all meters and concentrations tested was as follows:

| Glucose Conc. (mg/dL) | Standard Deviation (mg/dL) | Coefficient of Variation (%) |
| --- | --- | --- |
| 42.5 | 1.49 | 3.52 |
| 94.0 | 2.30 | 2.44 |
| 134.6 | 5.79 | 2.31 |
| 217.6 | 5.79 | 2.66 |
| 373.7 | 8.46 | 2.26 |

The Day to Day precision testing was performed using three glucose levels of control solutions; ten individual users performed this evaluation using ten meters over a period of ten days, for a total of 100 measurements per level. This was repeated with three lots of test strips.

| Lot A | | | |
| --- | --- | --- | --- |
| Level | Low | Mid | High |
| Mean | 44.8 mg/dL | 117.4 mg/dL | 355.1 mg/dL |
| Standard Deviation | 0.66 | 1.51 | 5.98 |
| Coefficient of Variation (%) | 1.46 | 1.29 | 1.68 |

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| Lot B | | | |
| --- | --- | --- | --- |
| Level | Low | Mid | High |
| Mean | 45.4 mg/dL | 121.8 mg/dL | 360.6 mg/dL |
| Standard Deviation | 1.16 | 2.60 | 7.60 |
| Coefficient of Variation (%) | 2.54 | 2.13 | 2.11 |
| Lot C | | | |
| --- | --- | --- | --- |
| Level | Low | Mid | High |
| Mean | 42.9 mg/dL | 123.2 mg/dL | 366.8 mg/dL |
| Standard Deviation | 1.23 | 3.15 | 7.96 |
| Coefficient of Variation (%) | 2.88 | 2.56 | 2.17 |

b. Linearity/assay reportable range:

The measuring range of the device is 20-600 mg/dL. A linearity study was conducted consistent with CLSI EP6-A using venous whole blood collected in a 10 mL vacuum sample tube. Glucose was adjusted to 11 concentration levels ranging from 13 to 708 mg/dL (The Lo and Hi detection was disabled for this testing). Ten measurements were taken at each glucose concentration. The linear regression line for three lots was: y = 0.98x + 3.56, r² = 0.998.

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

The sponsor assigned control values based on data collected with the PocketChem EZ Blood Glucose Meter and the new strips.

Shelf life studies show that the unopened test strips have a twenty-four month lifespan and a three month shelf-life once a vial of strips is opened. The recommended storage temperature is 39° F - 86° F (4° C - 30° C).

d. Detection limit:

The detection limit is 20 mg/dL. See linearity/assay reportable range above.

e. Analytical specificity:

A total of 15 readings were taken for each glucose level and concentration of interferent (5 unique test strips per each of 3 lots). Three glucose levels were tested for each interferent including a low (50 - 80 mg/dL range), medium (125 - 160 mg/dL range), and high (310 - 400 mg/dL range). Bias was calculated as the mean difference in glucose reading between the test and control concentration groups.

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Standard deviations and 95% confidence intervals (CIs) for the mean bias were also calculated. Percent bias was calculated as the bias divided by the mean glucose level at the control concentration. Standard deviations and 95% CIs for percent bias were also reported.

No significant interference was defined by the sponsor as follows: for glucose levels less than 75 mg/dL there is no interference if the lower bound of the 95% CI for bias is ≥ -10 mg/dL and the upper bound is ≤ 10 mg/dL and for glucose levels ≥ 75 mg/dL, there is no interference if the lower bound of the 95% CI for percent bias is ≥ -10% and the upper bound is ≤ 10%.

Based on the definition of interference above, ascorbic acid at 6 mg/dL was found to interfere. This is described in the labeling as:

Ascorbic acid (Vitamin C), when occurring in normal blood or normal therapeutic concentrations, does not significantly affect results. However, abnormally high concentrations in blood may cause inaccurately high results.

The following substances were found not to significantly interfere based upon the definition of interference above:

- Acetaminophen up to 20 mg/dL
- Acetyl-Salicylic Acid up to 65 mg/dL
- Cholesterol up to 500 mg/dL
- Conjugated bilirubin up to 70 mg/dL
- Creatinine up to 5.0 mg/dL
- Dopamine up to 0.09 mg/dL
- Ephedrine up to 0.06 mg/dL
- Fructose up to 30 mg/dL
- Galactose up to 60 mg/dL
- Gentisic Acid up to 1.8 mg/dL
- Glutathione up to 3.00 mmol/L
- Hemoglobin up to 735 mg/dL
- Ibuprofen up to 50 mg/dL
- L-DOPA up to 13 mg/dL
- Lactose up to 30 mg/dL
- Maltose up to 450 mg/dL
- Maltotetraose up to 450 mg/dL
- Maltotoriose up to 240 mg/dL
- Mannitol up to 800 mg/dL
- Mannose up to 16 mg/dL
- Methyl-L-Dopa up to 1.5 mg/dL
- Salicylic Acid up to 100 mg/dL
- Sorbitol up to 10 mg/dL
- Tetracycline up to 1.5 mg/dL
- Tolazamide up to 70 mg/dL

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Triglyceride up to 3300 mg/dL
Tolbutamide up to 64 mg/dL
Unconjugated Bilirubin up to 33 mg/dL
Urea up to 280 mg/dL
Uric Acid up to 23 mg/dL
Warfarin up to 1.0 mg/dL
Xylitol up to 50 mg/dL
Xylose up to 80 mg/dL

## Altitude Study

A study was conducted to evaluate the effect of altitude on the PocketChem EZ Blood Glucose Meter using the new glucose strips. Venous blood was collected from a donor in a sodium heparin tube and allowed to undergo glycolysis at room temperature to lower the endogenous glucose to approximately 40 mg/dL. The sample was separated into 4 aliquots and spiked with glucose to levels of approximately 60, 125, 300 and 480 mg/dL. After spiking to obtain the 4 different levels, the glucose values were confirmed with the YSI glucose analyzer. The tests were performed at approximately 900 feet and at 10,000 feet. At each altitude, venous blood at each of the 4 levels of glucose was tested on the same test strip lot. The meter readings obtained at 10,000 feet were compared to the meter readings at sea level and the % bias was determined at each level.

Results recovered within ± 15 mg/dL at blood glucose levels of < 75 mg/dL and ± 15% at glucose levels > 75 mg/dL when compared to the readings near sea level. The labeling states that the Arkray Assure Pro test strips can be used at elevations up to 10,000 feet above sea level.

## Hematocrit Study

The sponsor performed hematocrit studies comparing the PocketChem EZ result at various hematocrits across the glucose measuring range to the Assure Pro at a normal hematocrit and to a reference analyzer. Hematocrit levels tested were 30, 37, 42, 53, and 55% and glucose levels tested were approximately 31, 51, 75, 121, 180, 342, 452, and 521 mg/dL. All of the comparisons to the reference analyzer and to a normal hematocrit showed a bias of less than ±15 mg/dL at glucose concentrations less than 75 mg/dL or less than ±15% at glucose concentrations ≥75 mg/dL.

f. Assay cut-off:

Not applicable.

2. Comparison studies:

a. Method comparison with predicate device:

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A method comparison study was performed with 119 capillary fingerstick samples where the participants tested themselves. The distribution of gender, diabetes type, age, and education level were as follows. Note: one participant was found to be hypoglycemic and was removed from the study for medical reasons. Results from this participant were not included in the study.

| Gender | Number | % of Total |
| --- | --- | --- |
| Male | 70 | 58 |
| Female | 50 | 42 |
| Diabetes | Number | % of Total |
| --- | --- | --- |
| Type 1 | 47 | 39 |
| Type 2 | 68 | 57 |
| Not specified | 5 | 4 |
| Age Group | Number | % of Total |
| --- | --- | --- |
| 18 – 30 | 9 | 7.5 |
| 31 – 40 | 14 | 11.7 |
| 41 – 50 | 26 | 21.7 |
| 51 – 60 | 24 | 20.0 |
| 61 – 70 | 26 | 21.7 |
| 71 – 82 | 21 | 17.5 |

An additional 21 values were obtained from capillary blood that was allowed to undergo glycolysis to lower glucose or were spiked with glucose to raise values, for a total of 140 measurements. The range of concentrations of unaltered samples was $47 - 522\mathrm{mg / dL}$ by the reference method. The total range of concentrations, with the contrived samples, was $36 - 571\mathrm{mg / dL}$ by the reference method.

The linear regression line for this study was:

$$
y = 1.02x - 7.7, r^2 = 0.99
$$

In the format of ISO 15197, the accuracy is as follows:

Fingerstick accuracy for glucose concentrations $< 75\mathrm{mg / dL}$

(PocketChem EZ vs. YSI)

| Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL |
| --- | --- | --- |
| 4/16 (25%) | 10/16 (63%) | 16/16 (100%) |

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Fingerstick accuracy for glucose concentrations $\geq 75\,\mathrm{mg/dL}$

(PocketChem EZ vs. YSI)

| Within ± 5 % | Within ± 10 % | Within ± 15 % | Within ± 20 % |
| --- | --- | --- | --- |
| 58/124 (47%) | 111/124 (90%) | 122/124 (98%) | 124/124 (100%) |

The sponsor also evaluated the accuracy of samples taken from the palm where the participants tested themselves. The results in ISO 15197 format are below:

Palm accuracy for glucose concentrations $< 75\,\mathrm{mg/dL}$ (PocketChem EZ vs. YSI)

| Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL |
| --- | --- | --- |
| 5/6 (83%) | 6/6 (100%) | 6/6 (100%) |

Palm accuracy for glucose concentrations $\geq 75\,\mathrm{mg/dL}$ (PocketChem EZ vs. YSI)

| Within ± 5 % | Within ± 10 % | Within ± 15 % | Within ± 20 % |
| --- | --- | --- | --- |
| 49/112 (44%) | 85/112 (76%) | 108/112 (96%) | 111/112 (99%) |

b. Matrix comparison:

Not applicable. Only capillary whole blood samples can be used with this meter.

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):

The minimum recommended sample volume for this system is $0.5\,\mu\mathrm{L}$. To validate performance the sponsor performed testing at sample volumes of $0.2\,\mu\mathrm{L} - 10\,\mu\mathrm{L}$. The results demonstrated that across the range of volumes tested, the system produced either a result with acceptable accuracy, an error code with no result or in

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the case of extremely low volumes, the measurement did not start and no result was displayed.

4. Clinical cut-off:
Not applicable.

5. Expected values/Reference range:
Expected values for people without diabetes¹:
Fasting: <100 mg/dL
1 – 2 hours after meals < 140 mg/dL
¹ Joslin Diabetes Center: Goals for Blood Glucose Control, 2008. www.joslin.org

N. Instrument Name:
PocketChem EZ 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 each additional reading.

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:
This device is intended to be used with capillary whole blood from the finger and palm only. Since the whole blood sample is applied directly to the test strip, there are no special handling or storage issues.

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5. **Calibration:**

The user is instructed to insert the code chip when the meter is turned off, and then to insert a test strip, which turns the meter on. The meter automatically detects the code number when a test strip is inserted. The user must check to see if the code number the meter displays matches the number on the test strip vial. If the number matches, the user is instructed to begin testing. If the number does not match, the user is instructed not to perform a test and to make sure the correct code chip is being used for that bottle of strips. No other calibration is required from the user.

6. **Quality Control:**

Two levels of control are supplied with the device. Users are instructed to test control solutions when the meter is first used in order to verify that they can use the meter correctly. In addition they are instructed to run a control when a new vial of test strips is opened, when they suspect the meter or strips are not working correctly, if test results appear to be abnormally high or low, or are not consistent with the patient's symptoms, if the meter is dropped, to check their technique, if the test strip bottle had been left open or stored outside its recommended temperature range, and each time the batteries are changed.

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

The sponsor performed a readability assessment of the labeling and states that the user manual, strip insert, and control insert are at an eighth grade reading level or below. Note: the strip insert was determined to be at a reading level of 8.7 when the technical section targeting professional users was included. When this section was not included, the reading level drops to 7.4.

**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.