ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM

K092104 · Arkray Factory USA, Inc. · CGA · Nov 24, 2009 · Clinical Chemistry

Device Facts

• Record ID: K092104
• Device Name: ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Arkray Factory USA, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Nov 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Assure Platinum Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. 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 Assure Platinum Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Story

System uses biosensor technology to measure glucose in capillary whole blood. User applies blood sample to test strip; glucose reacts with glucose oxidase and Hexaamineruthenium (III) chloride, generating electric current proportional to glucose concentration. Meter converts current to glucose value. Used at home by patients or in clinical settings by professionals. Auto-coding feature eliminates manual calibration. Provides quantitative glucose results to aid diabetes management. Includes quality control solutions to verify system accuracy.

Clinical Evidence

Clinical testing evaluated accuracy of finger stick measurements. Bench testing included evaluation of interferences, dynamic range, linearity, hematocrit effects, altitude effects, control solution functionality, and analytical precision. Results supported substantial equivalence.

Technological Characteristics

System uses electrochemical sensing principle. Components include meter, test strips, and control solution (Normal/High). Operates on fresh capillary whole blood. Designed for OTC and clinical use. Bench testing performed per FDA guidance for glucose monitoring systems.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from fingertips. For use by persons with diabetes (OTC) or healthcare professionals in clinical settings to monitor diabetes control. 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

• Assure Pro (k053079)

Submission Summary (Full Text)

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

A. 510(k) Number:
k092104

B. Purpose for Submission:
Addition of new test strips to a previously cleared 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 Factory USA, Inc.

F. Proprietary and Established Names:
Assure Platinum 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
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.

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2. **Indication(s) for use:**

**Assure Platinum Blood Glucose Monitoring System:**

The Assure Platinum Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. 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 Assure Platinum Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

**Assure Platinum Blood Glucose Meter:**

The Assure Platinum Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. 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.

**Assure Platinum Blood Glucose Test Strips:**

Assure Platinum test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips when used with the Assure Platinum 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 with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

**Assure Dose CONTROL:**

For use with Assure Platinum Blood Glucose Meter and Assure Platinum 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 – Normal (Level 1) and High (Level 2).

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:**

**Assure Platinum Blood Glucose Meter**

I. **Device Description:**

The Assure Platinum 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.

J. **Substantial Equivalence Information:**

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1. Predicate device name(s):
Assure PRO Blood Glucose Monitoring System

2. Predicate 510(k) number(s):
k053079

3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | New Device Assure Platinum | Predicate - k053079 Assure Pro |
| Indications for use | Same | As an aid to monitor the effectiveness of diabetes control |
| Maximum Altitude | Same | 10,000 ft. |
| Anatomical Sites | Fingertip | Fingertip |
| Operating Temperature Range | Same | 50° F to 104° F |
| Operating Humidity Range | Same | 20 – 80% |
| Hematocrit Range | Same | 30 – 55% |
| Differences | | |
| --- | --- | --- |
| Item | New Device Assure Platinum | Predicate - k053079 Assure Pro |
| Enzyme and Associated Reagents | Glucose Oxidase (Aspergillus niger) and Hexaamineruthenium (III) Chloride | Glucose Oxidase (Aspergillus niger) |
| Double Dosing Capability | No | Yes |
| Code Chip | No/auto-coding | Required |
| Test Time | 7 sec | 10 Seconds |
| 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 EP-6A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline, 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 Hexaamineruthenium (III) chloride in the test strip. This produces Hexaamineruthenium (II) chloride. Hexaamineruthenium (II) chloride is produced in proportion to the glucose concentration of the blood sample.
Oxidation of the Hexaamineruthenium (II) chloride produces an electric current. The meter

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converts the current to the glucose concentration and displays it as the test result:

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

D-Glucono-δLactone + Hexaamineruthenium (II) chloride

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

# M. Performance Characteristics (if/when applicable):

# 1. Analytical performance:

# a. Precision/Reproducibility:

Within-Day precision testing was performed using fresh venous whole blood obtained from several non-diabetic volunteers and adjusted to a pO2 of 60 to $80\mathrm{mmHg}$ and hematocrit of $42\%$ . The whole blood was spiked to obtain 5 glucose concentrations ranging from $38.8 - 585.2\mathrm{mg/dL}$ . Within-Day precision tests consisted of 10 measurements of each of the 6 spiked whole blood glucose samples using 10 meters for each sample for a total of 600 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 (%) |
| --- | --- | --- |
| 38.8 | 1.12 | 2.90 |
| 101.6 | 2.31 | 2.28 |
| 142.4 | 3.24 | 2.28 |
| 219.1 | 6.10 | 2.78 |
| 388.5 | 6.34 | 1.63 |
| 585.2 | 9.20 | 1.57 |

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 10 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 | 37.4 mg/dL | 132.6 mg/dL | 344.6 mg/dL |
| Standard Deviation | 0.70 | 2.66 | 8.97 |
| Coefficient of Variation (%) | 1.87 | 2.01 | 2.60 |
| Lot B | | | |
| Level | Low | Mid | High |
| Mean | 35.3 mg/dL | 124.6 mg/dL | 324.7 mg/dL |
| Standard Deviation | 0.71 | 2.89 | 8.56 |
| Coefficient of Variation (%) | 2.03 | 2.32 | 2.64 |
| Lot C | | | |

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| Level | Low | Mid | High |
| --- | --- | --- | --- |
| Mean | 39.7 mg/dL | 138.5 mg/dL | 358.2 mg/dL |
| Standard Deviation | 0.76 | 2.75 | 9.75 |
| Coefficient of Variation (%) | 1.92 | 1.99 | 2.72 |

# b. Linearity/assay reportable range:

The measuring range of the device is $20 - 600\mathrm{mg / dL}$ . A linearity study was conducted consistent with CLSI EP6-A using venous whole blood collected in a $10~\mathrm{mL}$ vacuum sample tube. Glucose was adjusted to 11 concentration levels ranging from 17 to 650 $\mathrm{mg / dL}$ (The Lo and Hi detection was disabled for this testing). Ten Assure Platinum meter measurements were taken at each glucose concentration. The linear regression line for three lots was: $\mathrm{y} = 1.02\mathrm{x} - 0.93961$ , $\mathrm{r}^2 = 0.9988$ .

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

The control solutions used in this device have been previously cleared (k053079). Only the name of the control solutions has been changed.

Real time studies for the test strips are on-going and currently support up to 4 months when stored at $39^{\circ}\mathrm{F} - 86^{\circ}\mathrm{F}$ . Shelf life studies using accelerated aging show that the unopened test strips have a twenty-four month life-span. The sponsor recommends a three month shelf-life once a vial of strips is opened based upon real time study data. The recommended storage temperature is $39^{\circ}\mathrm{F} - 86^{\circ}\mathrm{F}$ ( $4^{\circ}\mathrm{C} - 30^{\circ}\mathrm{C}$ ).

# d. Detection limit:

The detection limit is $20\mathrm{mg / dL}$ . See linearity/assay reportable range above.

# e. Analytical specificity:

The sponsor evaluated the interference from different concentrations of the substances listed below. Three glucose levels were tested for each interferent including a low (50 - 80 mg/dL range), medium (120 - 160 mg/dL range), and high (302 - 382 mg/dL range). A total of 15 readings were taken for each glucose level and concentration of interferent (5 meters per each of 3 test strip lots). Studies demonstrated that all the interfering substances listed below did not significantly interfere with the glucose readings except that ascorbic acid (6 mg/dL) produced $14\%$ bias and triglycerides (3300 mg/dL) produced $12\%$ bias:

Acetaminophen up to $20\mathrm{mg / dL}$

Acetyl-Salicylic Acid up to $65\mathrm{mg / dL}$

Ascorbic acid up to $6\mathrm{mg / dL}$

Bilirubin (unconjugated) up to $33\mathrm{mg / dL}$

Bilirubin (conjugated) up to $67\mathrm{mg / dL}$

Cholesterol up to $500\mathrm{mg / dL}$

Creatinine up to $5.0\mathrm{mg / dL}$

Dopamine up to $0.09\mathrm{mg / dL}$

Ephedrine up to $0.14\mathrm{mg / dL}$

Fructose up to $30\mathrm{mg / dL}$

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Galactose up to 60 mg/dL
Gentisic Acid up to 1.8 mg/dL
Glutathione up to 3.00 mg/dL
Hemoglobin up to 1470 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 800 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
Triglyceride up to 3300 mg/dL
Tolbutamide up to 64 mg/dL
Urea up to 280 mg/dL
Uric Acid up to 22.5 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 Assure Platinum Glucose Meter using the Assure Platinum test strips. Venous blood collected from a donor was 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. These glucose values were confirmed with the YSI glucose analyzer. The tests were performed at approximately 900 feet and at 10,500 feet. At each altitude, venous blood at each of the 4 levels of glucose was tested on the same test strip lot with 10 replicates. The meter readings obtained at 10,500 feet were compared to the meter readings at 900 feet and the % bias was determined at each level. Results recovered within 8% when compared to the readings near sea level. The labeling states that the Assure Platinum strips can be used at elevations up to 10,000 feet above sea level.

## Hematocrit Study

The sponsor performed hematocrit studies comparing the Assure Platinum result at various hematocrit levels across the glucose measuring range to the normal hematocrit level and to a reference analyzer. Hematocrit levels tested were 30, 37, 42, 53, and 55%. The glucose levels tested were approximately 30, 50, 75, 120, 180, 341, and 452 mg/dL. Ten replicate measurements were taken at each hematocrit and

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glucose concentration. Testing was performed on 3 lots of test strips. Based on the comparisons to the reference analyzer and to normal hematocrit (42%), the results for hematocrit levels between 30-55% showed a bias of less than ±15% at all glucose concentrations.

f. Assay cut-off:
Not applicable.

2. Comparison studies:

a. Method comparison with predicate device:

A method comparison study was performed with 101 capillary fingerstick samples where the participants tested themselves. Testing was performed on 3 lots of Assure Platinum strips using ??? Assure Platinum meters. 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 | 42 | 42 |
| Female | 59 | 58 |
| Diabetes | Number | % of Total |
| --- | --- | --- |
| Type 1 | 44 | 44 |
| Type 2 | 57 | 56 |
| Age Group | Number | % of Total |
| --- | --- | --- |
| 18 – 30 | 11 | 11 |
| 31 – 40 | 17 | 17 |
| 41 – 50 | 33 | 32 |
| 51 – 60 | 18 | 18 |
| 61 – 70 | 20 | 20 |
| 71 – 82 | 2 | 2 |

The range of concentrations of 101 samples was 60 – 373 mg/dL by the reference method (YSI). The linear regression line for the accuracy study was, y = 1.08x – 9.74, r = 0.96. The accuracy for Assure Platinum vs. YSI in the format of ISO 15197 is given below.

Fingerstick accuracy for glucose concentrations < 75 mg/dL:

(Assure Platinum vs. YSI)

| Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL |
| --- | --- | --- |
| 2/6 (33%) | 6/6 (100%) | 6/6 (100%) |

Fingerstick accuracy for glucose concentrations ≥ 75 mg/dL:

(Assure Platinum vs. YSI)

| Within ± 5 % | Within ± 10 % | Within ± 15 % | Within ± 20 % |
| --- | --- | --- | --- |

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| 47/95 (49%) | 71/95 (75%) | 83/95 (87%) | 92/95 (97%) |
| --- | --- | --- | --- |

Professionals performed a fingerstick on the 101 users and analyzed the samples in duplicate using 2 meters. The blood glucose distribution of the 101 clinical samples did not fulfill the distribution recommended by ISO 15197; therefore, an additional 43 samples were obtained from capillary blood that was allowed to undergo glycolysis to lower glucose or were spiked with glucose to raise values. These samples ranged $26.1 - 479.7\mathrm{mg / dL}$ . The results in duplicates for both fingerstick and supplemental samples generated by professionals in the format of ISO 15197 are given below.

Professional fingerstick accuracy for glucose concentrations $< 75\mathrm{mg / dL}$ (Assure Platinum vs. YSI)

| Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL |
| --- | --- | --- |
| 42/48 (88%) | 48/48 (100%) | 48/48 (100%) |

Professional fingerstick accuracy for glucose concentrations $\geq 75\mathrm{mg / dL}$ (Assure Platinum vs. YSI)

| Within ± 5 % | Within ± 10 % | Within ± 15 % | Within ± 20 % |
| --- | --- | --- | --- |
| 127/240 (53%) | 189/240 (79%) | 231/240 (96%) | 240/240 (100%) |

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 the sponsor's sample volume claim of $0.5\mu \mathrm{L}$ is supported.

4. Clinical cut-off: Not applicable.

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

Fasting: $< 100\mathrm{mg / dL}$

1 - 2 hours after meals $< 140\mathrm{mg / dL}$

Joslin Diabetes Center: Goals for Blood Glucose Control, 2008. www.joslin.org

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N. Instrument Name:
Assure Platinum 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 only. Since the whole blood sample is applied directly to the test strip, there are no special handling or storage issues.

5. Calibration:
No calibration is required from the user. The meter accommodates auto-coding, in that each strip is designed and manufactured to code the meter appropriately when the strip is inserted.

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 lay user instructions in the user manual, strip insert, and control insert are at 7.0, 7.5, and 7.5 grade level, respectively.

The detection of the strip calibration code is automatic. A calibration code is determined during the manufacture of each lot of test strips. Calibration process uses fresh venous blood

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and glucose concentrations are adjusted to cover the dynamic range of the meter. The data are evaluated to determine the optimal calibration code which is preprogrammed in the meter software. Once the code is identified, it is transferred to each test strip. The strip is inserted into the meter strip connector, and the meter detects the configuration of the strip and selects one of the pre-defined calibration curves built into the meter's software.

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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