ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM

K101299 · Roche Diagnostics · LFR · Sep 21, 2011 · Clinical Chemistry

Device Facts

• Record ID: K101299
• Device Name: ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Roche Diagnostics
• Product Code: LFR · Clinical Chemistry
• Decision Date: Sep 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

Device Story

System measures capillary whole blood glucose; utilizes ACCU-CHEK Aviva meter and Aviva Plus test strips with modified GDH-PQQ enzyme. User applies 0.6 μL blood sample to strip; meter applies AC voltages at four frequencies to assess sample/environment, followed by DC voltage to measure glucose-proportional current. System provides hematocrit and temperature-compensated results. Intended for single-patient home use; operated by patient. Output displayed on meter; aids in diabetes management. Includes code key for calibration; supports data transmission to external devices.

Clinical Evidence

Clinical performance evaluated via user study with 195 subjects (fingertip) and 314 (palm), 155 (forearm), 156 (upper arm). Accuracy compared to hexokinase reference method. Results showed high correlation (r=0.989 for fingertip). System accuracy for glucose ≥75 mg/dL met 99.2% within ±20% for fingertip samples. Bench testing included precision, linearity, interference, hematocrit (10-65%), and altitude (up to 10,000 ft) studies.

Technological Characteristics

Disposable dry reagent test strip; electrochemical sensing; Mut. Q-GDH enzyme; PQQ coenzyme; electrochemical mediator; meter-based display; single-patient use design.

Indications for Use

Indicated for people with diabetes for self-testing of capillary whole blood glucose from fingertips, forearm, upper arm, or palm to monitor diabetes control. Contraindicated for neonates, diagnosis/screening of diabetes, and patients who are dehydrated, hypotensive, in shock, critically ill, or in a hyperosmolar state.

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 Aviva System (K060620 and K043474)

Submission Summary (Full Text)

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SEP 2 1 2011

# 510(k) Summary

KI01299 ______________________________________________________________________________________________________________________________________________________________________

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter<br>name,<br>address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone]<br>Contact Person: Mike Flis<br>Date Prepared: August 03, 2011 |
| 2) Device<br>name | Proprietary name:<br>ACCU-CHEK® Aviva Plus Blood Glucose Monitoring<br>System<br>Meter: ACCU-CHEK Aviva Meter<br>Test Strip: ACCU-CHEK Aviva Plus Test Strip<br>Controls: ACCU-CHEK Aviva Control Solutions<br>Classification name: Glucose dehydrogenase, glucose test system<br>(21 C.F.R. § 862.1345)<br>NBW, Blood Glucose Test System, Over-the-Counter<br>LFR, Glucose Dehydrogenase |
| 3) Predicate<br>device | ACCU-CHEK Aviva System (K060620 and K043474) |

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### 510(k) Summary, Continued

4) Device The modified test strip is a blood glucose testing product used in conjunction Description with the ACCU-CHEK® Aviva meter.

> Through the use of molecular-cloning techniques, Roche has modified the GDH enzyme to improve specificity for glucose; the modified reaction is referred to hereafter as Mut. Q-GDH.

The newly advanced test strip measures blood glucose rapidly and reliably via an electrochemical detection technique. The new version of the test strip employs a disposable dry reagent based on the Mut. Q-GDH method for glucose determination.

When a drop of blood is applied to the test strip, modified glucose dehydrogenase catalyzes the oxidation of glucose. During the reaction, electrons are transferred via the coenzyme PQQ and an electrochemical mediator to the surface of the electrode. Current generated by the reaction is proportional to the concentration of glucose present in the blood sample.

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### 510(k) Summary, Continued

The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended 5) Intended use to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

> The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

> The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

The single-patient use ACCU-CHEK Aviva Blood Glucose Monitoring System will consist of:

Meter: ACCU-CHEK Aviva Meter Test Strip: ACCU-CHEK Aviva Plus Test Strip Controls: ACCU-CHEK Aviva Control Solutions

#### 6) Substantial equivalence

The modified ACCU-CHEK Aviva Plus Test System is substantially equivalent to the ACCU-CHEK Aviva System (K060620 and K043474).

7) Data demonstrati ng substantial equivalence

Performance testing on the ACCU-CHEK Aviva System demonstrated that the device meets the performance requirements for its intended use. The data demonstrates that the test strip is substantially equivalent to the predicate device.

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Public Health Service

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Food and Drug Administrati 10903 New Hampshire Avenue Silver Spring, MD 20993

SEP ? 1 2011

Roche Diagnostics c/o Mike Flis Regulatory Affairs Program Manager 9115 Hague Road Indianapolis. IN. 46250-0457

Re: k101299 Trade Name: ACCU-CHEK Aviva Plus Blood Glucose Monitoring System Regulation Number: 21 CFR \$862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Codes: NBW. LFR. JJX Dated: September 16, 2011 Received: September 19, 2011

Dear Mr. Flis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class 111 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at [phone]. Also, please nate the regulation entitled, "Misbranding by reference to premarket noufication" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] for (1 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/orYou/Industry/default.htm.

Sincerely yours,

AJ

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

## 510(k) Number (if known): k101299 Device Name: ACCU-CHEK Aviva Plus Blood Glucose Monitoring System

Indications for Use:

The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).

The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

Prescription Use (Part 21 CFR 801 Subpart D) AND

Over-The-Counter Use XX (Part 21 CFR 801 Subpart C) ুন সম্ম

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Ruth Chaler

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k \ 0'2 qq

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