ACCU-CHEK AVIVA SYSTEM

K043474 · Roche Diagnostics Corp. · LFR · Apr 27, 2005 · Clinical Chemistry

Device Facts

• Record ID: K043474
• Device Name: ACCU-CHEK AVIVA SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: LFR · Clinical Chemistry
• Decision Date: Apr 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The ACCU-CHEK® Aviva system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring blood glucose in the home or health care facility. The device is intended for professional use and over-the-counter sale. Professionals may use the test strip to test capillary and venous blood samples; lay use is limited to capillary whole blood testing. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.

Device Story

The ACCU-CHEK Aviva system is a blood glucose monitoring device for home or clinical use. It consists of a meter, reagent test strips, control solutions, and a lancing device. The user inserts a test strip into the meter, applies a capillary blood sample (0.6 μL) to the strip, and the meter provides a quantitative glucose result in 5 seconds. The system uses glucose dehydrogenase technology and electrochemical biamperometry to measure glucose concentration. It automatically distinguishes between blood samples and control solutions. The device provides plasma-equivalent results. Healthcare providers use these results to monitor glycemic control in patients with diabetes. The system includes an expiration notification feature linked to the test strip code key.

Clinical Evidence

Bench testing only. Precision studies (N=10 per level) showed CVs ranging from 1.5% to 4.21%. Linearity established across 3-677 mg/dL. Method comparison with reference method (N=97) yielded R=0.982. Matrix comparison (N=212 capillary, N=227 venous) showed high correlation (R≥0.994). Alternate site testing (AST) accuracy study (N=pooled data) showed 3.2% of results outside ISO 15197 criteria, meeting the 5% acceptance threshold. Hematocrit range tested: 23-51%.

Technological Characteristics

Glucose dehydrogenase-based electrochemical test system. Utilizes AC/DC electrical impedance for glucose measurement and environmental compensation. Features code key-based calibration, desiccated test strip vials, and automated expiration tracking. Dimensions/materials not specified. Standalone meter operation.

Indications for Use

Indicated for quantitative blood glucose monitoring in patients with diabetes. Suitable for professional use (capillary and venous blood) and over-the-counter lay use (capillary blood only). Testing sites include fingertip, palm, forearm, upper arm, thigh, and calf.

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

• ACCU-CHEK Advantage system (K010362)
• ACCU-CHEK Advantage system (K032552)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ONLY TEMPLATE

A. 510(k) Number: k043474

B. Purpose For Submission:

Premarket Notification 510(k) of intention to manufacture and market the Roche Diagnostics Corp. ACCU-CHEK Aviva System.

C. Analyte: Whole Blood Glucose

D. Type of Test: Quantitative, utilizing Glucose dehydrogenase technology.

E. Applicant: Roche Diagnostics

F. Proprietary and Established Names: ACCU-CHEK® Aviva 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)

3. Product Code: NBW, LFR, JJX

4. Panel: 75 Chemistry

H. Intended Use:

1. Intended use(s):

See Indications for Use below.

2. Indication(s) for use:

The ACCU-CHEK® Aviva system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring blood glucose in the home or health care facility. The device is indicated for professional use and over-the-counter sale. Professionals may use the test strips to test capillary and venous blood samples; lay use is limited to capillary whole blood testing. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.

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3. Special condition for use statement(s):

Provides plasma equivalent results.

4. Special instrument Requirements:

Roche Diagnostics Corp. ACCU-CHEK® Aviva System

I. Device Description:

The ACCU-CHEK Aviva system utilizes reagent test strips stored within a desiccated vial. A test strip is removed from the vial and inserted into the meter. Upon insertion, the meter is activated. Blood is applied to the end of the test strip and a glucose result is reported.

The ACCU-CHEK Aviva system includes:
- ACCU-CHEK Aviva meter with battery
- ACCU-CHEK test strips and code key (may be sold separately)
- ACCU-CHEK Aviva control solutions (may be sold separately)
- ACCU-CHEK Softclix lancet device (with blue cap for fingertip testing and a clear cap for non-fingertip testing)
- ACCU-CHEK Softclix lancets

J. Substantial Equivalence Information:

1. Predicate device name(s):

Roche Diagnostics, Corp. ACCU-CHEK Advantage System

2. Predicate K number(s): K010362 and K032552

3. Comparison with Predicate:

The sponsor claims that the Roche Diagnostics ACCU-CHEK Aviva system is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Roche Diagnostics ACCU-CHEK Advantage system.

Similarities

| Topic | Comment |
| --- | --- |
| Intended Use | Both systems are intended for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities. |
| Closed system | Each system’s test strips and controls are designated to be used only with that |

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# Differences

| Topic | ACCU-CHEK Aviva | ACCU-CHEK Advantage |
| --- | --- | --- |
| Indication of control solution results | Automatically distinguishes control solution from whole blood samples. | User must identify (flag) the control solution result manually. |
| Test sample volume | 0.6 μL | 4.0 μL |
| Test time | 5 seconds | 26 seconds (Comfort Curve test strips) |
| Expiration | In addition to information included in labeling, the code key contains expiration date of associated test strips. System informs user when code key has expired. | No notification of expiration beyond that included in labeling. |
| Test strip technology | The system utilizes both AC/DC electrical impedance information. | The system utilizes electrical biamperometry information. |
| Labeling instructions regarding expected results | The normal fasting blood glucose range for an adult without diabetes is 74-106 mg/dL. Two hours after meals, the blood glucose range for an adult without | The normal fasting adult blood glucose range for a non-diabetic is 70-105 mg/dL. One to tow hours after meals, normal blood glucose levels should be |
| | in the first 24 hours. | in the first 24 hours. |
| Analyses of the test results | In order to assess the test results, the test strip is used to determine the test results. The test strip is used to determine the test results in a 100% confidence interval. | In order to assess the test results, the test strip is used to determine the test results in a 50% confidence interval. |

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| | diabetes is less than 140 mg/dL. For people with diabetes: please consult your doctor for the blood glucose range appropriate for you. | less than 140 mg/dL. Doctors will determine the range that is appropriate for their individual patients. |
| --- | --- | --- |

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

NCCLS EP6-A standard, “Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach.”

ISO 15197 standard minimum acceptable accuracy acceptance criteria (within ±15 mg/dL for <75 mg/dL and within ±20% for ≥75 mg/dL)

QA 43-SOP Procedure for Establishing the Precision Claim of Blood Glucose Systems.

## L. Test Principle:

The ACCU-CHEK Aviva System utilizes Glucose dehydrogenase technology. The enzyme glucose dehydrogenase converts the glucose in a blood sample to gluconolactone. This reaction liberates an electron that reacts with a coenzyme electron acceptor, the oxidized form of the mediator hexacyanoferrate (III), forming the reduced form of the mediator hexacyanoferrate (III). The test strip employs the electrochemical principle of biamperometry. The meter applies a voltage between two identical electrodes, which causes the reduced mediator formed during the incubation period to be reconverted to an oxidized mediator. This generates a small current that is read by the meter and reported as the glucose result.

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

### 1. Analytical performance:

#### a. Precision/Reproducibility:

The sponsor indicated precision studies were assessed by taking venous blood samples that were treated with EDTA, and spiking these samples to generate 5 different levels of glucose concentration for the test. Each of the samples was measured 10 times. Below are the Glucose Concentration Ranges and results for each level that was measured.

| Blood | Level 1
30-50 mg/dL | Level 2
51-110 mg/dL | Level 3
111-150 mg/dL | Level 4
151-250 mg/dL | Level 5
251-400 mg/dL |
| --- | --- | --- | --- | --- | --- |
| N | 10 | 10 | 10 | 10 | 10 |
| Mean | 38 | 107 | 143 | 245 | 341 |
| SD | 1.6 | 3.0 | 3.7 | 4.9 | 7.5 |
| CV | 4.21 | 2.8 | 2.6 | 2.0 | 2.2 |

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# Day-to-Day precision also known as Between Day Precision

The Day-to-Day precision according to the sponsor was determined by preparing three control and blood solutions of Low, Normal and High. The sponsor indicated that the protocol used for this comparison was based on requirements outlined in QA 43-SOP Procedure for Establishing the Precision Claim of Blood Glucose Systems. As an outcome of this study, the following precision claim is included in the labeling of the product:

| Control Solution | Low (mg/dL) | Mid (mg/dL) | High (mg/dL) |
| --- | --- | --- | --- |
| N | 10 | 10 | 10 |
| Mean | 41 | 130 | 306 |
| SD | 1.1 | 2.4 | 5.0 |
| CV | 2.68 | 1.8 | 1.5 |
| Blood | Low (mg/dL) | Mid (mg/dL) | High (mg/dL) |
| --- | --- | --- | --- |
| N | 10 | 10 | 10 |
| Mean | 38 | 143 | 341 |
| SD | 1.6 | 3.7 | 7.5 |
| CV | 4.21 | 2.6 | 2.2 |

# b. Linearity/assay reportable range:

The linearity was established by diluting specimens to cover the range of $3 - 677\mathrm{mg / dL}$

For linearity, the sponsor chose to use the ISO 15197 Standard minimum acceptable accuracy acceptance criteria (within $\pm 15\mathrm{mg / dL}$ for glucose results $< 75\mathrm{mg / dL}$ , and within $\pm 20\%$ for glucose results $\geq 75\mathrm{mg / dL}$ ) see low end data below.

| Test Strip Lot | Hitachi HK Reference Value (mg/dL) | Meter Response (mg/dL) | Consumer would see |
| --- | --- | --- | --- |
| 74 | 3.1 | 1 | LO |
| 74 | 3.1 | 1 | LO |
| 72 | 3.1 | 1 | LO |
| 72 | 3.1 | 1 | LO |
| 72 | 3.1 | 1 | LO |
| 72 | 3.1 | 1 | LO |
| 73 | 3.1 | 1 | LO |
| 73 | 3.1 | 1 | LO |
| 74 | 3.1 | 2 | LO |
| 74 | 3.1 | 2 | LO |
| 73 | 3.1 | 2 | LO |
| 73 | 3.1 | 2 | LO |

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| Test Strip Lot | Hitachi HK Reference Value (mg/dL) | Meter Response (mg/dL) | Consumer would see |
| --- | --- | --- | --- |
| 72 | 13.4 | 1 | LO |
| 72 | 13.4 | 3 | LO |
| 72 | 13.4 | 3 | LO |
| 72 | 13.4 | 3 | LO |
| 72 | 13.4 | 4 | LO |
| 72 | 13.4 | 5 | LO |
| 72 | 13.4 | 5 | LO |
| 72 | 16.2 | 5 | LO |
| 72 | 13.4 | 6 | LO |
| 72 | 16.2 | 6 | LO |
| 72 | 18.4 | 6 | LO |
| 72 | 18.4 | 6 | LO |
| 72 | 16.2 | 7 | LO |
| 72 | 16.2 | 7 | LO |
| 72 | 16.2 | 7 | LO |
| 72 | 16.2 | 7 | LO |
| 72 | 18.4 | 7 | LO |
| 72 | 18.4 | 7 | LO |
| 72 | 16.2 | 8 | LO |
| 72 | 18.4 | 8 | LO |
| 72 | 18.4 | 8 | LO |
| 72 | 20.8 | 8 | LO |
| 72 | 18.4 | 9 | LO |
| 72 | 18.4 | 9 | LO |
| 72 | 20.4 | 10 | 10 |
| 72 | 20.4 | 10 | 10 |
| 72 | 20.4 | 10 | 10 |
| 72 | 20.8 | 10 | 10 |
| 72 | 20.8 | 10 | 10 |
| 72 | 20.4 | 11 | 11 |
| 72 | 20.8 | 11 | 11 |
| 72 | 20.8 | 11 | 11 |
| 72 | 20.4 | 12 | 12 |
| 72 | 20.4 | 12 | 12 |
| 72 | 20.8 | 12 | 12 |
| 72 | 20.8 | 12 | 12 |
| 72 | 20.4 | 13 | 13 |
| 73 | 13.4 | 7 | LO |
| 73 | 13.4 | 7 | LO |
| 73 | 13.4 | 7 | LO |
| 73 | 13.4 | 9 | LO |

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| Test Strip Lot | Hitachi HK Reference Value (mg/dL) | Meter Response (mg/dL) | Consumer would see |
| --- | --- | --- | --- |
| 73 | 18.4 | 10 | 10 |
| 73 | 13.4 | 11 | 11 |
| 73 | 16.2 | 11 | 11 |
| 73 | 16.2 | 11 | 11 |
| 73 | 16.2 | 11 | 11 |
| 73 | 18.4 | 11 | 11 |
| 73 | 18.4 | 11 | 11 |
| 73 | 18.4 | 11 | 11 |
| 73 | 13.4 | 12 | 12 |
| 73 | 13.4 | 12 | 12 |
| 73 | 16.2 | 12 | 12 |
| 73 | 16.2 | 12 | 12 |
| 73 | 16.2 | 12 | 12 |
| 73 | 18.4 | 12 | 12 |
| 73 | 18.4 | 12 | 12 |
| 73 | 13.4 | 13 | 13 |
| 73 | 16.2 | 13 | 13 |
| 73 | 16.2 | 13 | 13 |
| 73 | 18.4 | 13 | 13 |
| 73 | 18.4 | 13 | 13 |
| 73 | 20.8 | 13 | 13 |
| 73 | 20.8 | 13 | 13 |
| 73 | 20.4 | 14 | 14 |
| 73 | 20.4 | 14 | 14 |
| 73 | 20.8 | 14 | 14 |
| 73 | 20.8 | 14 | 14 |
| 73 | 20.4 | 15 | 15 |
| 73 | 20.4 | 15 | 15 |
| 73 | 20.8 | 15 | 15 |
| 73 | 20.8 | 15 | 15 |
| 73 | 20.4 | 16 | 16 |
| 73 | 20.4 | 16 | 16 |
| 73 | 20.8 | 16 | 16 |
| 73 | 20.4 | 17 | 17 |
| 73 | 20.4 | 17 | 17 |
| 74 | 13.4 | 6 | LO |
| 74 | 13.4 | 7 | LO |
| 74 | 13.4 | 8 | LO |
| 74 | 13.4 | 8 | LO |
| 74 | 13.4 | 9 | LO |
| 74 | 13.4 | 9 | LO |
| 74 | 13.4 | 11 | 11 |
| 74 | 16.2 | 12 | 12 |

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| Test Strip Lot | Hitachi HK Reference Value (mg/dL) | Meter Response (mg/dL) | Consumer would see |
| --- | --- | --- | --- |
| 74 | 16.2 | 12 | 12 |
| 74 | 16.2 | 12 | 12 |
| 74 | 16.2 | 12 | 12 |
| 74 | 18.4 | 12 | 12 |
| 74 | 18.4 | 12 | 12 |
| 74 | 13.4 | 13 | 13 |
| 74 | 16.2 | 13 | 13 |
| 74 | 16.2 | 13 | 13 |
| 74 | 16.2 | 13 | 13 |
| 74 | 18.4 | 13 | 13 |
| 74 | 18.4 | 13 | 13 |
| 74 | 18.4 | 13 | 13 |
| 74 | 18.4 | 13 | 13 |
| 74 | 16.2 | 14 | 14 |
| 74 | 18.4 | 14 | 14 |
| 74 | 20.4 | 14 | 14 |
| 74 | 20.8 | 14 | 14 |
| 74 | 20.4 | 15 | 15 |
| 74 | 20.4 | 15 | 15 |
| 74 | 20.8 | 15 | 15 |
| 74 | 20.8 | 15 | 15 |
| 74 | 20.8 | 15 | 15 |
| 74 | 20.4 | 16 | 16 |
| 74 | 20.4 | 16 | 16 |
| 74 | 20.4 | 16 | 16 |
| 74 | 20.8 | 16 | 16 |
| 74 | 20.8 | 16 | 16 |
| 74 | 20.4 | 17 | 17 |
| 74 | 20.8 | 17 | 17 |
| | | | |
| count | 132 | 132 | |
| mean | 16.5 | 10 | |
| min | 3.12 | 1 | |
| max | 20.8 | 17 | |

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ACCU-CHEK Aviva (K#043474) - Low End Performance Data

c. Traceability (controls, calibrators, or method):

During the control solution production process, anhydrous glucose material is weighed out to within 0.2% of the target weight. Prior to bottling the final product a sample of the solution is verified via a Hitachi hexokinase method.

d. Detection limit:

See linearity above

10 – 600 mg/dL

0.6 to 33.3 mmol/L

e. Analytical specificity:

According the sponsor interference testing was conducted to determine the effect of select endogenous and exogenous substances. Testing was conducted using a glucose depleted normal human serum matrix spiked with the potential interferents at the acceptable upper concentrations. The recommended test level was based on EP7-A NCCLS guidelines and literature references. This study included a total of 177 compounds which were screened, of which the following will be claimed as limitation:

- Galactose
- Lipidemia (Triglycerides)

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- Maltose
- Xylose (Xylose will not be tested in whole blood but will be listed as a limitation based on serum results.

The below compounds when determined to be in excess of their limitations, may produce elevated results:

1. Galactose > 10 mg/dL can give falsely elevated test results.
2. Maltose > 13 mg/dL delivered intravenously can give falsely elevated test results.
3. Lipids (Triglycerides) > 4800 mg/dL can give falsely elevated test results

f. Assay cut-off:

Not Applicable

2. Comparison studies:

a. Method comparison with predicate device:

A consumer blood study comparisons, to the Reference Method was conducted, where capillary blood sample results obtained by untrained patients from three physician offices gave the following results.

$$
N = 97
$$

$$
Y = 0.957x + 2.7
$$

$$
R = 0.982
$$

$$
\text{Range} = 73 - 330 \text{ mg/dL}
$$

b. Matrix comparison:

Studies for matrix comparison were conducted at one physician site for capillary blood samples and three physician office sites for venous blood samples with the following results:

| Capillary Blood | Venous Blood |
| --- | --- |
| N = 212 | N = 227 |
| Y = 0.984x + 2.2 | Y = 0.993x + 0.3 |
| R = 0.996 | R = 0.994 |
| Range = 26 – 461 mg/dL | Range = 32 – 583 mg/dL |

Alternate Site Testing

The sponsor demonstrated Alternate Site Testing (AST) of the palm, forearm, upper arm, thigh, and calf with the clearance of 510(k) submission K022171 Roche Diagnostics ACCU-CHEK Compact System. The sponsor has AST studies on two (2) sites with the new device, comparing to the fingertip as the reference method in this submission.

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In the AST accuracy study performed by the sponsor, a trained technician performed a minimum of four capillary sticks on each patient to include a capillary fingerstick as a reference, capillary forearm stick, capillary palm thenar (thumb side) and a second capillary fingerstick used and hematocrit sample. As indicated in the above previously cleared submission K022171, the sponsor has included label warnings not recommending AST testing during periods of rapidly decreasing or increasing blood glucose levels.

The percentage of individual results falling outside 15 mg/dL for glucose results < 75 mg/dL and 20% for glucose results ≥ 75 mg/dL was 3.2% for the pooled data, which was not significantly higher than the 5% acceptance criteria. The Hematocrit range obtained was 23-51% with a mean of 40.5%.

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): Not Applicable

4. Clinical cut-off: Not Applicable

5. Expected values/Reference range:

The normal fasting blood glucose range for an adult without diabetes as related to plasma is 74-106 mg/dL¹. Two hours after meals, blood glucose range for a non-diabetic is less than 140 mg/dL². For people with diabetes please consult your diabetes team for the blood glucose range appropriate for you.

1. Stedman, TL, Stedman’s Medical Dictionary, 27th Edition, 1999, pg. 2082.
2. American Diabetes Association, Clinical Practice Recommendation Guidelines 2003, Diabetes Care, Vol. 26. Supplement 1, p. S22.

N. Proposed Labeling:

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

O. Conclusion:

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