ACCU-CHEK AVIVA PLUS SYSTEM

K133862 · Roche Diagnostics Corporation · NBW · Apr 29, 2014 · Clinical Chemistry

Device Facts

• Record ID: K133862
• Device Name: ACCU-CHEK AVIVA PLUS SYSTEM
• Applicant: Roche Diagnostics Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 29, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

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 consists of ACCU-CHEK Aviva meter and Aviva Plus test strips. Device measures glucose in capillary whole blood samples. User applies blood to test strip; meter performs quantitative measurement. Designed for single-patient home use by individuals with diabetes. Modification from predicate involves removal of code key requirement. Output displayed on meter screen to assist users in monitoring diabetes control. No remote processing or cloud connectivity described.

Clinical Evidence

Bench testing only. Studies included software validation, EMC safety, linearity, accuracy, and lay user studies. Robustness and disinfection efficacy testing performed for 260 cycles, simulating 5-year use life; validated complete inactivation of HBV.

Technological Characteristics

Glucose dehydrogenase-based blood glucose monitoring system. Consists of meter and test strips. Modification involves removal of code key functionality. Intended for in vitro diagnostic use.

Indications for Use

Indicated for single-patient use for blood glucose monitoring.

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 Plus System (K101299)

Submission Summary (Full Text)

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K133862

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## 510(k) Summary

# APR 2 9 2014

Roche)

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
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| 1) Submitter name, address, contact | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone]<br>Contact Person: Khone Saysana<br>Date Prepared: December 17, 2013 |
| 2) Device name | Proprietary name:<br>ACCU-CHEK® Aviva Plus Blood Glucose Monitoring 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 (21 C.F.R. § 862.1345)<br>NBW, Blood Glucose Test System, Over-the-Counter<br>LFR, Glucose Dehydrogenase |
| 3) Predicate device | ACCU-CHEK Aviva Plus System (K101299) |
| 4) Device<br>Description | The modified ACCU-CHEK Aviva meter used in conjunction with the<br>ACCU-CHEK® Aviva Plus test strips. The new ACCU-CHEK Aviva meter<br>no longer uses a code key. |
| 5) Intended<br>use | The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended<br>to be used for the quantitative measurement of glucose (sugar) in fresh<br>capillary whole blood samples drawn from the fingertips, forearm, upper arm,<br>or palm. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is<br>intended to be used by a single person and should not be shared. |
| | The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended<br>for self testing outside the body (in vitro diagnostic use) by people with<br>diabetes at home as an aid to monitor the effectiveness of diabetes control.<br>The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System should not<br>be used for the diagnosis of or screening of diabetes or for neonatal use.<br>Alternative site testing should be done only during steady - state times (when<br>glucose is not changing rapidly). |
| | The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK<br>Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh<br>capillary whole blood samples drawn from the fingertips, forearm, upper arm,<br>or palm. |
| | The single-patient use ACCU-CHEK Aviva Blood Glucose Monitoring<br>System will consist of: |
| | Meter: ACCU-CHEK Aviva Meter<br>Test Strip: ACCU-CHEK Aviva Plus Test Strip<br>Controls: ACCU-CHEK Aviva Control Solutions |
| 6) Substantial<br>equivalence | The modified ACCU-CHEK Aviva meter is substantially equivalent to the<br>ACCU-CHEK Aviva Plus System (K101299). |
| 7) Data<br>demonstrating<br>substantial<br>equivalence | Performance testing on the ACCU-CHEK Aviva System demonstrated that<br>the device meets the performance requirements for its intended use. The data<br>demonstrates that the test strip is substantially equivalent to the predicate<br>device. |

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## 510(k) Summary, Continued

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20093-0002

April 29,2014

ROCHE DIAGNOSTICS CORPORATION KHONE SAYSANA REGULATORY AFFAIRS PRINCIPAL 9115 HAGUE ROAD INDIANAPOLIS IN 46250

Re: K133862

Trade/Device Name: ACCU-CHEK Aviva Plus Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: 11 Product Code: NBW Dated: March 28. 2014 Received: March 31. 2014

Dear Khone Saysana:

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 (o 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. Iisting of devices. good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. 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 (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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Page 2-Khone Saysana

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/ReportalProblem/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

### Katherine Serrano -S

For: Courtney H. Lias. Ph.D.

> Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K133862

Device Name

ACCU-CHEK Aviva Plus Blood Glucose Monitoring System

#### Indications for Use (Describe)

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, 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.

Type of Use (Select one or both, as applicable)

J Prescription Use (Part 21 CFR 801 Subpart D)

Z Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

## Stayce Beck -S

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