GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1

K073137 · Apex BioTechnology Corp. · NBW · Apr 1, 2008 · Clinical Chemistry

Device Facts

• Record ID: K073137
• Device Name: GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1
• Applicant: Apex BioTechnology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 1, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The GlucoSure Voice Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Testing is done outside the body (In Vitro diagnostic use). The meter includes voice functionality to assist visually impaired users. It is indicated for both lay use by people with diabetes and in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus.

Device Story

GlucoSure Voice is a blood glucose monitoring system comprising a meter, test strips, and control solutions. It measures glucose in fresh capillary whole blood from fingertips, forearm, or palm. Designed for both home use by patients with diabetes and clinical use by healthcare professionals. Features voice functionality to assist visually impaired users in reading results. The system provides quantitative glucose levels to aid in monitoring diabetes management. Users apply blood to a test strip inserted into the meter; the device processes the sample and displays/announces the glucose concentration. Clinical performance was verified through comparison of fingertip and alternate site testing (AST) results against professional reference methods, utilizing linear regression, Clarke Error Grid, and bias analysis. The device also includes control solutions to validate system performance and user technique.

Clinical Evidence

Clinical testing performed on persons with diabetes to verify performance for fingertip and alternate site testing (palm and forearm). Results compared against professional reference methods. Data analyzed via linear regression, Clarke Error Grid, and bias analysis; results met pass/fail criteria. Voice functionality evaluated with visually impaired users. Non-clinical testing included precision, linearity, and temperature/humidity effects.

Technological Characteristics

System includes meter, test strips, and control solutions. Features voice output for accessibility. Supports capillary whole blood sampling from multiple sites (fingertip, forearm, palm).

Indications for Use

Indicated for quantitative blood glucose measurement in patients with Diabetes Mellitus. Suitable for lay use by individuals with diabetes and clinical use by healthcare professionals. Supports fingertip, forearm, and palm capillary whole blood sampling. Includes voice functionality for visually impaired users.

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

• GlucoTrack BGM (k062799)

Submission Summary (Full Text)

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

A. 510(k) Number:
k073137

B. Purpose for Submission:
Modification of a cleared device (addition of voice capabilities)

C. Measurand:
Whole blood glucose

D. Type of Test:
Whole Blood Glucose Concentration through a Quantitative Amperometric Assay (Glucose Oxidase)

E. Applicant:
Apex Biotechnology Corp.

F. Proprietary and Established Names:
GlucoSure Voice Blood Glucose Monitoring System

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1345, Glucose Test System
21 CFR § 862.1660, Single (specified) analyte controls (assayed and unassayed)
2. Classification:
Class II
Class I (reserved)
3. Product code:
NBW, CGA, JJX
4. Panel:
75 (Clinical Chemistry)

H. Intended Use:
1. Intended use(s):
See indications for use below.
2. Indication(s) for use:
The GlucoSure Voice Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Testing is done outside the body (In Vitro diagnostic use). The meter includes voice functionality to assist visually impaired users. It is indicated for both lay use by people with diabetes and in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus.

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The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring system using a testing solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.

3. Special conditions for use statement(s):
- Not for neonatal use
- Not for screening or diagnosis of diabetes mellitus
- Alternative site testing is for use at times of steady state only
- For Over-the-Counter use
- Not for use in critically ill patients or those in hyperosmolar state

4. Special instrument requirements:
GlucoSure Voice Blood Glucose Monitoring System

I. Device Description:
The GlucoSure Voice Blood Glucose Monitoring System is based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 6 seconds. The control solutions available are used to test the performance of the device.

J. Substantial Equivalence Information:
1. Predicate device name(s):
Apex Biotechnology Corp. GlucoTrack Blood Glucose Monitoring System
2. Predicate 510(k) number(s):
k062799
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Detection Method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase | Glucose Oxidase |
| Test Range | 20 – 600 mg/dL | 20 – 600 mg/dL |
| Volume Required | 1 μL | 1 μL |
| Hematocrit Range | 30-55% | 30-55% |
| Test Time | 6 seconds | 6 seconds |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Alternate Site Testing | Yes | No |
| Voice Output | Yes | No |

K. Standard/Guidance Document Referenced (if applicable):
CLSI EP5-A: Evaluation of Precision Performance of Clinical Chemistry Devices
CLSI EP6-P: Evaluation of the Linearity of Quantitative Measurement Procedures

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ISO 15197: In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.

L. Test Principle:
Glucose measurement is based on electrical potential caused by the reaction of glucose with the reagents contained on the strip's electrodes. The glucose in the sample is oxidized by the enzyme glucose oxidase, and the current resulting from this enzymatic reaction is measured and converted to glucose concentration by the meter. The magnitude of the current is proportional to the concentration of glucose in the sample.

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
The sponsor evaluated the within run precision of the device using 20 replicate measurements of 5 concentrations of glucose-adjusted venous whole blood and 2 concentrations of control solutions with 3 strip lots.

The sponsor also evaluated the between run precision of the device using replicate measurements of venous whole blood samples and glucose controls. Twenty replicates at 5 different concentrations and 2 levels of controls were each tested with 3 strip lots over 20 days. Results met the sponsor's acceptance criteria of a standard deviation ≤ 4.5 mg/dL when the glucose concentration was <75 mg/dL and less than a 6% CV for glucose concentrations ≥ 75 mg/dL. Results are summarized in the table below.

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| Whole blood samples | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Within-Run | | Between Run | | Overall | |
| Strip lot | Mean (mg/dL) | SD | %CV | SD | %CV | SD | %CV |
| FS 002i | 31 | 1.73 | -- | 1.24 | -- | 2.46 | -- |
| | 82 | 3.18 | 3.7% | 2.01 | 2.5% | 3.57 | 4.3% |
| | 156 | 5.82 | 3.6% | 3.90 | 2.5% | 5.82 | 3.7% |
| | 386 | 6.46 | 1.7% | 8.70 | 2.3% | 13.34 | 3.5% |
| | 575 | 26.55 | 4.7% | 14.36 | 2.5% | 21.15 | 3.7% |
| FS 002J | 35 | 2.91 | -- | 1.40 | -- | 3.03 | -- |
| | 84 | 2.26 | 2.8% | 2.52 | 3.0% | 3.76 | 4.5% |
| | 154 | 6.02 | 3.9% | 4.21 | 2.7% | 6.04 | 3.9% |
| | 384 | 13.45 | 3.5% | 5.61 | 1.5% | 12.09 | 3.1% |
| | 586 | 21.29 | 3.6% | 8.34 | 1.4% | 16.87 | 2.9% |
| FS 002K | 34 | 2.47 | -- | 1.71 | -- | 3.10 | -- |
| | 83 | 1.90 | 2.2% | 2.62 | 3.2% | 3.48 | 4.2% |
| | 158 | 5.25 | 3.2% | 2.90 | 1.8% | 5.43 | 3.4% |
| | 380 | 5.12 | 1.4% | 6.67 | 1.8% | 10.61 | 2.8% |
| | 576 | 9.23 | 1.6% | 8.85 | 1.5% | 14.93 | 2.6% |
| Control Solution | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Within-Run | | Between Run | | Overall | |
| Strip Lo | Mean (mg/dL) | SD | %CV | SD | %CV | SD | %CV |
| FS 002i | 87 | 3.97 | 4.6% | 2.05 | 2.3% | 3.94 | 4.5% |
| | 192 | 6.38 | 3.4% | 3.85 | 2.0% | 6.92 | 3.6% |
| FS 002J | 87 | 3.53 | 4.0% | 2.38 | 2.7% | 4.11 | 4.7% |
| | 196 | 7.59 | 4.0% | 3.66 | 1.9% | 6.60 | 3.4% |
| FS 002K | 90 | 3.71 | 4.1% | 2.82 | 3.1% | 4.30 | 4.8% |
| | 194 | 7.00 | 3.6% | 4.83 | 2.5% | 7.22 | 3.7% |

b. Linearity/assay reportable range:

To establish the linearity of the GlucoSure Voice Meter system through the range of 20 to $600\mathrm{mg / dL}$ glucose adjusted whole blood samples were compared to YSI 2300. The sponsor tested 8 samples that spanned the claimed measuring range 4 times using 10 different meters and 3 different strip lots. Linear regression yields the following statistics:

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| | Slope | y-intercept | r2 |
| --- | --- | --- | --- |
| Strip Lot 1 | 1.055 | -7.128 | 0.998 |
| Strip Lot 2 | 1.033 | -4.587 | 0.999 |
| Strip Lot 3 | 1.049 | -7.152 | 0.998 |

The sponsor claims 20 mg/dL as the lowest detectable limit in the labeling.

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

The controls were evaluated in the predicate device (k062799). The evaluation of the controls in that submission is described below.

The device is traceable to a laboratory analyzer which is calibrated to a glucose standard (NIST SRM 965a).

Stability characteristics of both levels of control solutions were determined using real time aging studies to determine the open vial storage stability at room temperature to be 18 months and unopened vial stability to be 24 months.

The expected values for the two glucose control solutions were established by repeat testing (10 times) on two meters using one lot of strips for both glucose levels. The expected results may change with each new lot, but the control range is listed in the product insert.

d. Detection limit:

The measuring range of the GlucoSure Voice Blood Glucose Monitoring System is 20 - 600 mg/dL. This range was verified by the linearity study (above).

e. Analytical specificity:

Analytical specificity was evaluated in the predicate device (k062799).

f. Assay cut-off:

Not Applicable

2. Comparison studies:

a. Method comparison with predicate device:

A consumer study was performed with 152 lay-users and a technician (with 6 samples contrived to produce low sample values) to see if glucose readings from the fingertip were comparable to a laboratory glucose reference method and that alternate site testing were comparable to fingertip. The labeling provided to the users was in English only. Each participant performed their own fingerstick and tested their blood using the instructions in the user's manual. The 6 contrived samples ranged from 34.3 - 47.6 mg/dL and the real samples ranged from 48.8 - 478 mg/dL. Results are summarized below using a single finger stick values (where the labeling uses a mean fingerstick value of two results):

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| Patient | Fingerstick vs. YSI | Palm vs. Patient FingerStick | Forearm vs. Patient FingerStick |
| --- | --- | --- | --- |
| Samples < 75 mg/dL within ±15 mg/dL YSI | 10/11 (91%) | 11/11 (100%) | 10/11 (91%) |
| Samples ≥ 75 mg/dL within ± 20% YSI | 141/141 (100%) | 141/141 (100%) | 139/141 (99%) |
| Total | 151/152 (99%) | 152/152 (100%) | 149/152 (98%) |
| Technician | Fingerstick and contrived vs. YSI | Palm vs. Technician FingerStick | Forearm vs. Technician FingerStick |
| --- | --- | --- | --- |
| Samples < 75 mg/dL within ±15 mg/dL YSI | 17/17 (100%) | 11/11 (100%) | 11/11 (100%) |
| Samples ≥ 75 mg/dL within ± 20% YSI | 141/141 (100%) | 139/141 (99%) | 141/141 (100%) |
| Total | 158/158 (100%) | 150/152 (99%) | 152/152 (100%) |

The above studies were performed by lay users that were both normally sited and visually impaired (having severe presbyopia, retinopathy, cataracts, or glaucoma) who used the voice feature.

The sponsor showed the performance of the device by only the visually impaired users by evaluating those users blood glucose and comparing them to YSI as well as a user study to determine if the voice feature was satisfactory to users. The concentration of the samples ranged from 48.8 to $478\mathrm{mg / dL}$ . The results are summarized below.

| Visually Impaired | Fingerstick vs. YSI | Palm vs. Patient FingerStick | Forearm vs. Patient FingerStick |
| --- | --- | --- | --- |
| Samples < 75 mg/dL within ±15 mg/dL YSI | 2/3 (66%) | 3/3 (100%) | 3/3 (100%) |
| Samples ≥ 75 mg/dL within ± 20% YSI | 42/42 (100%) | 42/42 (100%) | 42/42 (100%) |
| Total | 44/45 (98%) | 45/45 (100%) | 45/45 (100%) |

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b. Matrix comparison:
Not applicable. Capillary whole blood is the only indicated matrix.

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 sponsor provided a readability study that indicated that the user manual, test strip labeling, and control solution labeling is at an 8th grade reading level or below.

4. Clinical cut-off:
Not Applicable.

5. Expected values/Reference range:
The sponsor included the following Expected Values for normal glucose levels in their strip labeling:

74~106 mg/dL before meals¹
Less than 140 mg/dL two hours after meal²

1. Stedman, Thomas Lathrop. Stedman's Medical Dictionary, 27th Edition, 1999, pg. 2082.
2. American Diabetes Association, "Clinical Practice Recommendations 2003." Diabetes Care, Vol 26, Supplement 1, pg. S22.

N. Instrument Name:
GlucoSure Voice Blood Glucose Monitoring System

O. System Descriptions:
1. Modes of Operation:
Each test strip is single use and must be replaced with a new strip for additional readings.
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, palm, or forearm only. Since the whole blood sample is applied directly to the test strip there are no special handling or storage issues.
5. Calibration:

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A code number is provided with each batch of test strips to calibrate the meter for that batch. The code number is associated with the meter by a coding card that is inserted into the meter that comes with each vial of test strips. No further calibrations are required of the user.

6. **Quality Control:**
The sponsor is providing a single level glucose control solution with this device as a "starter kit." There is a "simple kit" in which controls are not provided. Two levels are available for purchase as stated in the labeling. When a test strip is inserted into the meter, a control can be run. An acceptable range for each control level is printed on the test strip vial label. The user is referred to a troubleshooting section of the owner's manual to identify possible reasons control results fall outside these ranges.

P. **Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:**
None

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.