ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080

K060470 · Bayer Healthcare · NBW · Apr 12, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060470
• Device Name: ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080
• Applicant: Bayer Healthcare
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The Ascensia® CONTOUR® Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The Ascensia® CONTOUR® Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The Ascensia® CONTOUR® Blood Glucose Monitoring System is indicated for use with capillary, venous and arterial whole blood samples. Capillary samples may be drawn from the fingertip, palm, forearm, abdomen and thigh. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Device Story

System measures glucose in whole blood samples; includes meter, modified test strips, controls, and lancing device. Used by patients with diabetes (OTC) and healthcare professionals in home or clinical settings. Input: capillary, venous, or arterial whole blood applied to test strip. Principle of operation: glucose dehydrogenase-based electrochemical measurement. Output: quantitative blood glucose concentration displayed on meter. Results assist patients and clinicians in diabetes management and monitoring.

Clinical Evidence

Laboratory and clinical evaluations conducted with persons with diabetes. Performance compared against original Ascensia CONTOUR system and a laboratory reference method. Results demonstrated equivalent performance to the predicate device.

Technological Characteristics

Glucose dehydrogenase-based electrochemical measurement. No changes to fundamental scientific technology. System includes meter, modified test strips, controls, and lancing device.

Indications for Use

Indicated for persons with diabetes and healthcare professionals in home and clinical settings for blood glucose measurement. Compatible with capillary (fingertip, palm, forearm, abdomen, thigh), venous, and arterial whole blood samples. Used as an adjunct to diabetes care.

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

• Bayer Ascensia Contour Diabetes Care System (k023657)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
k060470

B. Purpose for Submission:
Change in technology for test strip

C. Measurand:
Glucose

D. Type of Test:
Quantitative, Glucose Dehydrogenase (FAD-GDH)

E. Applicant:
Bayer HealthCare

F. Proprietary and Established Names:
Ascensia® CONTOUR® Blood Glucose Monitoring System (modified test strip)

G. Regulatory Information:
1. Regulation section:
21 CFR §862.1345, Glucose test system
2. Classification:
Class II
3. Product code:
LFR, NBW
4. Panel:
75, Clinical Chemistry

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H. Intended Use:

1. Intended use(s):

See indication for Use section below.

2. Indication(s) for use:

The Ascensia® CONTOUR® Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The Ascensia® CONTOUR® Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.

The Ascensia® CONTOUR® Blood Glucose Monitoring System is indicated for use with capillary, venous and arterial whole blood samples. Capillary samples may be drawn from the fingertip, palm, forearm, abdomen and thigh.

The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

3. Special conditions for use statement(s):

For over the counter and prescription use.

Contraindication: Capillary blood glucose testing may not be clinically appropriate for persons with reduced peripheral blood flow. Shock, severe hypotension, hyperosmolar hyperglycemia and severe dehydration are examples of clinical conditions that may adversely affect the measurement of glucose in peripheral blood.

4. Special instrument requirements:

Ascensia CONTOUR Blood Glucose Meter (k023657)

I. Device Description:

The Ascensia® CONTOUR® Blood Glucose Monitoring System consists of the Ascensia CONTOUR Blood Glucose Meter, Ascensia CONTOUR or MICROFILL blood glucose test strips, lancet device, control solutions and instructions for use manual.

J. Substantial Equivalence Information:

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1. Predicate device name(s):

Bayer Ascensia Contour Diabetes Care System

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

k023657

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | Measures glucose in whole blood by people with diabetes or healthcare professionals | Measures glucose in whole blood by people with diabetes or healthcare professionals |
| Specimens Types | Capillary, venous or arterial blood | Capillary, venous or arterial blood |
| Anatomical Sites | Capillary samples from the fingertip, palm, forearm, abdomen and thigh | Capillary samples from the fingertip, palm, forearm, abdomen and thigh |
| Measuring range | 10-600 mg/dL | 10-600 mg/dL |
| Test time | 15 seconds | 15 seconds |
| Limitation | Do not use during Xylose absorption testing | Do not use during Xylose absorption testing |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Enzyme Used | FAD-GDH | PQQ-GDH |
| Limitation | Test strip does not have interference with maltose or icodextrin peritoneal dialysis solution | Test strip has interference problems with maltose and icodextrin peritoneal dialysis solution |

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

ISO International Standard 15197

# L. Test Principle:

The Ascensia CONTOUR Blood glucose meter measures the electrical current generated from the reaction of glucose with reagents on the electrode of the test strip. Glucose in the blood sample reacts with FAD glucose dehydrogenase and potassium ferricyanide in the test strip, generating electrons that produce a current that is proportional to the glucose in the sample.

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M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

The intra assay precision of the device was evaluated by assaying 5 whole blood specimens at different concentrations (50-325 mg/dL) within one run using 10 meters. The results are presented in the table below:

| | Level 1 | Level 2 | Level 3 | Level 4 | Level 5 |
| --- | --- | --- | --- | --- | --- |
| N | 100 | 100 | 100 | 100 | 100 |
| Grand Mean (mg/dL) | 48 | 102 | 126 | 202 | 338 |
| Pooled SD | 1.4 | 1.5 | 1.7 | 3.0 | 5.4 |
| Pooled %CV | 3.0 | 1.4 | 1.3 | 1.5 | 1.6 |
| Range %CV | 2.5 - 3.5 | 1.1 - 1.8 | 0.4 - 2.7 | 1.1 - 1.9 | 0.8 - 2.2 |

Inter assay precision was evaluated by assaying 3 control solutions of different concentrations (30-350 mg/dL) once a day for 10 days using 10 meters. The results are presented in the table below:

| | Level 1 | Level 2 | Level 3 |
| --- | --- | --- | --- |
| N | 100 | 100 | 100 |
| Grand Mean (mg/dL) | 39 | 116 | 356 |
| Pooled SD | 0.8 | 1.5 | 5.4 |
| Pooled %CV | 2.0 | 1.3 | 1.5 |
| Range %CV | 1.2 – 3.0 | 0.9 – 1.6 | 1.0 – 2.0 |

b. Linearity/assay reportable range:

The linearity of the glucose measurements was demonstrated by comparing 92 prepared blood samples on the Ascensia Contour meter and the YSI method. The concentration range of the samples was 10-609 mg/dL. Linear regression of comparison data yielded the following relationship:

$$
y = 0.986(x) - 2.0, r^2 = .997
$$

The reportable range is 10-600 mg/dL

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

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Traceability is referenced to the NIST SRM 917a (dry D-glucose).

# d. Detection limit:

The detection limit is $10\mathrm{mg / dL}$ . See the linearity study in b. above.

# e. Analytical specificity:

Interference of the assay was assessed by spiking various endogenous and exogenous compounds into prepared whole blood samples. The sponsor prepared a low whole blood sample at approximately $80\mathrm{mg / dL}$ and a high whole blood sample at approximately $350\mathrm{mg / dL}$ . The sponsor then added the interfering substance and ran each sample on the Ascensia Contour meter. The results are presented in the table below:

| Substance | Concentration | Sponsor's Allowable Bias |
| --- | --- | --- |
| Bilirubin | 20 mg/dL | 15% |
| Acetaminophen | 20 mg/dL | 20% |
| Uric Acid | 15 mg/dL | 20% |
| Ascorbic Acid | 5 mg/dL | 15% |
| Maltose | 200 mg/dL | 7% |
| Galactose | 200 mg/dL | 7% |

The sponsor presented data that supported using the test system between $10^{\circ}\mathrm{C}$ to $40^{\circ}\mathrm{C}$ .

# Hematocrit Effect:

The effect of sample hematocrit variation on the Ascensia Contour test system was tested by comparing the glucose result to the hematocrit value obtained both during the laboratory and the clinical study. A laboratory study was conducted to show performance at lower glucose concentrations with different hematocrits. Six blood samples at glucose concentrations between 10-60 mg/dL were adjusted to the following hematocrit levels $40\%$ , $55\%$ and $70\%$ and tested in 72 replicates. The results met the sponsor's acceptance criterion of $>95\%$ of readings within $\pm 15\mathrm{mg / dL}$ of the reference method. The comparison to the YSI plasma (x) values resulted in the following regression equations:

$40\%$ hematocrit $\mathrm{Y} = 0.918(\mathrm{x}) - 1.272, \mathrm{r}^2 = 0.995$

$55\%$ hematocrit $\mathrm{Y} = 0.875(\mathrm{x}) + 0.632, \mathrm{r}^2 = 0.994$

$70\%$ hematocrit $\mathrm{Y} = 0.781(\mathrm{x}) + 8.665, \mathrm{r}^2 = 0.984$

In another laboratory study, the effect of hematocrit was assessed using three lots of test strips with whole blood at four plasma glucose concentrations of 50, 100, 200 and $400\mathrm{mg / dL}$ adjusted to three hematocrit levels of $20\%$ $40\%$

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and 60%. The normalized bias from YSI at 40% hematocrit levels is as follows:

| 20% Hematocrit | | | 60% Hematocrit | |
| --- | --- | --- | --- | --- |
| YSI glucose | Modified strip | Bias | Modified strip | Bias |
| 50 | 55 | 10% | 53 | 6% |
| 100 | 110.1 | 10% | 91.2 | - 8.8% |
| 200 | 242.3 | 21% | 165.7 | - 17.1% |
| 400 | 473.3 | 18% | 291.8 | - 27.1% |

In the lay user study, samples were assayed using the Ascensia Contour modified test strip and compared to the YSI reference method. The glucose concentrations ranged from 53 mg/dL to 489 mg/dL and the hematocrits ranged from 29% to 59%. The data showed that 96.1% of the results were within ±15 mg/dL or 20% of the laboratory glucose method.

The claimed range for Hematocrit is 20~60%. A limitation is included in the labeling: "At glucose ranges above 200 mg/dL, hematocrit levels above 55% will cause lowered results."

f. Assay cut-off:

Not applicable.

2. Comparison studies:

a. Method comparison with predicate device:

Accuracy was based on the ISO International Standard 15197. Acceptable accuracy for results shall be: 95% of the individual results shall fall within ±15 mg/dL at glucose concentration <75 mg/dL and within 20% at glucose concentration ≥75 mg/dL. One hundred and six (106) capillary blood samples were collected and run on the Ascensia Contour meter and then run on a reference method. Three lots of test strips were tested with each participant; two replicates per lot for a total of 636 fingerstick readings. The sample range was from 58 to 485 mg/dL. Results are shown in the tables below:

Accuracy results for glucose concentration <75 mg/dL (4.2 mmol/L)

| Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL |
| --- | --- | --- |
| 11/12 (91.7%) | 12/12 (100%) | 12/12 (100%) |

Accuracy results for glucose concentration ≥75 mg/dL (4.2 mmol/L)

| Within ± 5 % | Within ± 10 % | Within ± 15 % | Within ± 20% |
| --- | --- | --- | --- |
| 304/624 (48.7%) | 517/624 (82.9%) | 609/624 (97.6%) | 624/624 (100%) |

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A linear regression was also performed and has the following results, $y = 0.98x - 1.7$ , $n = 106$ .

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):

The consumer study was performed at two POC sites with a total of 205 lay-users. The lay-users ranged in age, education and were equally divided between males and females. Each participant performed their own fingerstick and tested three different lots of the modified test strip. The Healthcare Provider performed testing also on all three test strips. A fingerstick blood sample was collected and measured on an YSI analyzer.

| Site | Number of samples | Ascensia vs. YSI | r value | Sample Range (mg/dL) |
| --- | --- | --- | --- | --- |
| Combined Lay-User and HCP Results | | | | |
| The1P | 582 | y=0.92x+1.00 | 0.954 | 53 – 460 |
| 2 | 612 | y=1.00x – 5.55 | 0.949 | 53 - 489 |

The Parks Error Grid for the combined results is:

| | Zone A | Zone B |
| --- | --- | --- |
| Lay-User | 92.8% | 7% |
| HCP | 93.3% | 7% |

# 4. Clinical cut-off:

Not applicable

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5. Expected values/Reference range:

The labeling provides the following statement: “Standard medical practice goals for a typical non-pregnant individual with diabetes are: fasting glucose 90 -130 mg/dL and post-prandial (2 hours after meals) less than 180 mg/dL.”¹

N. Proposed Labeling:

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

O. Conclusion:

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

¹ American Diabetes Association: Standards of Medical Care for Patients with Diabetes Mellitus (position statement). Diabetes Care 2001: 24(7): 1303-04