ACCU-CHEK AVIVA PLUS TEST STRIP

K131029 · Roche Diagnostics Operations, Inc. · NBW · Aug 9, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131029
• Device Name: ACCU-CHEK AVIVA PLUS TEST STRIP
• Applicant: Roche Diagnostics Operations, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 9, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Accu-Chek Aviva Plus System and Accu-Chek Aviva Combo System are intended for the quantitative measurement of glucose in fresh capillary whole blood samples from the finger, palm, forearm, or upper arm. The systems are intended for use by a single person and should not be shared. The systems are intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The systems are not intended for the diagnosis of or screening for diabetes mellitus, nor for use on neonates.

Device Story

System comprises blood glucose meter, test strips, control solutions, and insulin infusion pump. Meter accepts fresh capillary whole blood samples; uses electrochemical test strips to quantify glucose levels. Modified Black Code Key provides universal coding for test strip lots. Meter interfaces with insulin pump via radio frequency for remote control and dose calculation based on user-entered data. Used at home by patients for diabetes management. Output displayed on meter screen; informs insulin dosing and diabetes control monitoring. Benefits include integrated glucose monitoring and insulin delivery control.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures to confirm that the universal calibration key modification meets predetermined acceptance criteria.

Technological Characteristics

System includes glucose meter, test strips, and insulin pump. Uses electrochemical sensing for glucose measurement. Features radio frequency connectivity for meter-to-pump communication. Includes Black Code Key for universal test strip lot coding.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (finger, palm, forearm, upper arm) for single-patient self-testing by individuals with diabetes to monitor glycemic control. Not for neonatal use or diabetes diagnosis/screening.

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)
• Accu-Chek Aviva Combo System (K111353)

Submission Summary (Full Text)

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Roche > 长13)029

# 510(k) Summary

| 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: Khone Saysana<br>Date Prepared: April 10, 2013 | AUG 09 2013 | |
| 2) Device<br>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<br>(21 C.F.R. § 862.1345)<br>NBW, Blood Glucose Test System, Over-the-Counter<br>LFR, Glucose Dehydrogenase | | |
| | Proprietary name: ACCU-CHEK® Aviva Combo System<br>Common Name: Insulin infusion pump, glucose test system, and accessories<br>Classification name:<br>Pump, infusion, insulin (21 CFR 880.5725); Class II; Product Code: LZG Glucose test system (21 CFR 862.1345); Class II; Product Code: NBW Drug dosing calculator (21 CFR 868.1890); Class II; Product Code: NDC | | |
| 3) Predicate<br>device | ACCU-CHEK Aviva Plus System (K101299)<br>ACCU-CHEK Aviva Combo System (K111353) | | |

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| 4) Device<br>Description | The modified Black Code Key used in conjunction with the ACCU-CHEK®<br>Aviva meter and the ACCU-CHEK® Aviva Combo meter.<br><br>The Black Code Key contains a universal code and can be used on all<br>released ACCU-CHEK Aviva Plus test strip lots. |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |

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The ACCU-CHEK Combo System is indicated for the treatment of insulin 5) Intended requiring diabetes and for the quantitative measurement of glucose in fresh use continued capillary whole blood from the finger.

> The ACCU-CHEK Spirit Combo Insulin Pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. The ACCU-CHEK 360° Insulin Pump Configuration software facilitates the monitoring and programming of the pump settings.

The ACCU-CHEK Aviva Combo blood glucose system is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control. The ACCU-CHEK Aviva Combo blood glucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should NOT be used with the ACCU-CHEK Aviva Combo blood glucose monitoring system.

The ACCU-CHEK Aviva Plus test strips are for use with the ACCU-CHEK Aviva Combo blood glucose meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The ACCU-CHEK Aviva Combo meter can also be used to interface with, and remotely control the ACCU-CHEK Spirit Combo insulin infusion pumps via radio frequency communication. The ACCU-CHEK Aviva Combo meter is also indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data.

For in vitro diagnostic use The ACCU-CHEK Aviva Combo system is intended for single patient use and should not be shared.

The modified ACCU-CHEK Aviva Plus System with Black 6) Substantial Code Key is substantially equivalent to the ACCU-CHEK Aviva Plus System equivalence (K101299).

> The modified ACCU-CHEK Aviva Combo System with black code key is substantially equivalent to the ACCU-CHEK Aviva Combo System (K11353).

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#### 7) Data demonstrating substantial equivalence

Performance testing on the ACCU-CHEK Aviva Plus 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.

Performance testing on the ACCU-CHEK Aviva Combo 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0(8)2

August 9, 2013

Roche Diagnostics Corporation c/o Khone Saysana 9115 Hague Rd.. INDIANAPOLIS IN 46250

Re: K131029

Trade/Device Name: ACCU-CHEK® Aviva Combo System; ACCU-CHEK® Aviva Plus Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, LZG, NDC Dated: July 8, 2013 Received: July 10, 2013

Dear Mr. Saysana:

We have reviewed your Section 510(k) premarket notification of intent to market the device we ferenced 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). and Cosmetic Herefore, market the device. subject to the general controls provisions of the Act. The r ou may, therefore, manier the as act include requirements for annual registration, listing of general controls proficions gractice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. Teass note: Obter assess 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), If your device is classified (500 above) ... Existing major regulations 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 I least be advised that I Dr. 3 issuance orour device complies with other requirements of the Act that I DA has made a are regulations administered by other Federal agencies. You must or any i ederal stiller and regimanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (2) CFR Parts 801 and 809); medical device reporting (reporting of CrK Fall 607), ademig (21 CFR Paris 607), good manufacturing practice requirements mental device-related adverse orches) regulation (21 CFR Part 820); and if applicable, the as set form in the quality of stone (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Saysana

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance 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/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] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Carol C. Benson -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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### Indications for Use Form

### 510(k) Number: K131029 Device Name: ACCU-CHEK Aviva Plus Test 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 _____________________________________________________________________________________________________________________________________________________________ | AND | Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (Part 21 CFR 801 Subpart D) | | (Part 21 CFR 801 Subpart C) |

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

## Katherine Serrano -S

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k): K131029

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### Indications for Use Form

## 510(k) Number: K131029 Device Name: ACCU-CHEK Aviva Combo System

#### Indications for Use:

The ACCU-CHEK Combo System is indicated for the treatment of insulin requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.

The ACCU-CHEK Spirit Combo Insulin Pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. The ACCU-CHEK 360° Insulin Pump Configuration software facilitates the monitoring and programming of the pump settings.

The ACCU-CHEK Aviva Combo blood glucose system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control. The ACCU-CHEK Aviva Combo blood glucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should NOT be used with the ACCU-CHEK Aviva Combo blood glucose monitoring system.

The ACCU-CHEK Aviva Plus test strips are for use with the ACCU-CHEK Aviva Combo blood glucose meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Page 1 of 2

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The ACCU-CHEK Aviva Combo meter can also be used to interface with, and remotely control the ACCU-CHEK Spirit Combo insulin infusion pumps via radio frequency communication. The ACCU-CHEK Aviva Combo meter is also indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data.

For in vitro diagnostic use

The ACCU-CHEK Aviva Combo system is intended for single patient use and should not be shared.

Prescription Use __ XX___ (Part 21 CFR 801 Subpart D) AND

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

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

## Katherine Serrano -S

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k): K131029

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