ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM

K141867 · Roche Diagnostics · NBW · Mar 3, 2015 · Clinical Chemistry

Device Facts

• Record ID: K141867
• Device Name: ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Roche Diagnostics
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 3, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ACCU-CHEK Aviva Connect System is intended for single patient use.

Device Story

System measures blood glucose via amperometric detection using Mut. Q-GDH enzyme on capillary whole blood samples (0.6 µL). Device consists of meter, test strips, and control solutions. User applies blood to strip; meter calculates glucose concentration (20-600 mg/dL) in 5 seconds. Designed for single-patient home use. Modification from predicate includes USB port and BLE (Bluetooth Low Energy) for data transmission to personal computers/mobile devices. Meter features modified housing and button functionality. Provides quantitative results to aid diabetes management. No clinical decision-making automation described; output used by patient/physician for monitoring.

Clinical Evidence

Bench testing only. Performance data demonstrates the system meets requirements for intended use, including precision (SD ≤ 5.0 mg/dL for < 75 mg/dL; CV ≤ 5.0% for ≥ 75 mg/dL), hematocrit range (10-65%), and environmental operating conditions (57-100°F, 10-80% RH).

Technological Characteristics

Electrochemical glucose meter; BLE and USB connectivity; 3-button interface. Materials validated for 260 cleaning/disinfection cycles. Software includes embedded reporting features. Single-patient use design.

Indications for Use

Indicated for single patient use for the quantitative measurement of glucose in fresh capillary whole blood from the finger, palm, forearm, or upper arm as an aid in monitoring the effectiveness of diabetes control programs.

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 (K133862)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 3, 2015

ROCHE DIAGNOSTICS KHONE SAYSANA PRINCIPLE REGULATORY AFFAIRS, DIABETES CARE 9115 HAGUE ROAD INDIANAPOLIS IN 46250

Re: K141867

Trade/Device Name: ACCU-CHEK® Aviva Connect Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. LFR Dated: February 2, 2015 Received: February 3, 2015

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 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. 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 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 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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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" (21 CFR 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 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,

Stayce Beck -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

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### Indications for Use

510(k) Number (if known) K141867

#### Device Name

ACCU-CHEK Aviva Connect Blood Glucose Monitoring System

#### Indications for Use (Describe)

The ACCU-CHEK Aviva Connect 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. The ACCU-CHEK Aviva Connect Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The ACCU-CHEK Aviva Connect 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 Connect Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

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

For in vitro diagnostic use

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

] Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

| 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. |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>Name, Address,<br>Contact | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone]<br>Contact Person: Khone Saysana<br>Date Prepared: February 6, 2015 |
| Device Name | Proprietary name:<br>ACCU-CHEK® Aviva Connect Blood Glucose Monitoring System<br>Meter: ACCU-CHEK Aviva Connect Meter<br>Test Strip: ACCU-CHEK Aviva Plus Test Strip<br>Controls: ACCU-CHEK Aviva Control Solutions |
| | Classification name: Glucose dehydrogenase, glucose test system<br>(21 C.F.R. § 862.1345); Class II<br>NBW, Blood Glucose Test System, Over-the-Counter<br>LFR, Glucose Dehydrogenase |
| Predicate<br>Device | ACCU-CHEK Aviva Plus System (K133862), concurrence received on 30 April 2014. |
| Device<br>Description | The ACCU-CHEK Aviva Connect blood glucose monitoring system is a blood glucose monitoring system that makes use of the ACCU-CHEK Aviva Connect meter, the ACCU-<br>CHEK Aviva Plus test strips (k101299), and the ACCU-CHEK Aviva control solutions (k101299). The ACCU-CHEK Aviva Connect meter is a modification of the ACCU-CHEK Aviva meter (k133862) with an improved design and the addition of a USB port and the BLE communication capability. |

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| Summary of<br>Technological<br>Characteristics<br>Compared to<br>the Predicate<br>Device | System Feature | ACCU-CHEK Aviva Plus System<br>(k133862, predicate) | ACCU-CHEK Aviva<br>Connect System<br>(new device) |
|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| | Indications for<br>Use | The ACCU-CHEK Aviva Plus Blood Glucose<br>Monitoring System is intended to be used for<br>the quantitative measurement of glucose<br>(sugar) in fresh capillary whole blood samples<br>drawn from the fingertips. The ACCU-CHEK<br>Aviva Plus Blood Glucose Monitoring System<br>is intended to be used by a single person and<br>should not be shared. | Same |
| | | The ACCU-CHEK Aviva Plus Blood Glucose<br>Monitoring System is intended for self testing<br>outside the body (in vitro diagnostic use) by<br>people with diabetes at home as an aid to<br>monitor the effectiveness of diabetes<br>control. The ACCU-CHEK Aviva Plus Blood<br>Glucose Monitoring System should not be used<br>for the diagnosis of or screening of diabetes or<br>for neonatal use. | |
| | | The ACCU-CHEK Aviva Plus Test Strips are<br>for use with the ACCU-CHEK Aviva Plus<br>Blood Glucose Meter to quantitatively measure<br>glucose (sugar) in fresh capillary whole blood<br>samples drawn from the fingertips. | |
| | Meter<br>Communication | Infrared Communication via<br>dongle | USB (Universal Serial<br>Bus) and<br>BLE (Blue Tooth Low<br>Energy)<br>Communications |
| | AST Claims | Palm, Upper Arm and Forearm | None |
| | Meter Buttons | Arrow buttons on the front are<br>used to toggle through memory | Button functionality<br>has changed |
| | Embedded PC<br>Reports | No | Embedded Reports<br>available for<br>transmission to a<br>Personal<br>Computer |
| | Meter Housing | Black housing | Modified black housing |
| | Test Strip | Utilizes the ACCU-CHEK Aviva Plus test strip | Same |
| | Meter Coding | Universal code or blood glucose measurement<br>parameters are programmed into an internal<br>EEPROM | Same |
| System Feature | ACCU-CHEK Aviva Plus System<br>(k133862, predicate) | ACCU-CHEK Aviva<br>Connect System<br>(new device) | |
| Test Principle | Amperometric Detection | Same | |
| Enzyme | Mut. Q-GDH | Same | |
| Sample<br>Hematocrit | 10 to 65% | Same | |
| Maximum<br>Altitude | 10,000 feet | Same | |
| Measuring<br>Range | 20 - 600 mg/dL | Same | |
| Sample Volume | 0.6 µL | Same | |
| Test Time | 5 seconds | Same | |
| Operating<br>Temperature<br>and Relative<br>Humidity | (57 to 100°F)<br>10 to 80% r.h. | Same | |
| Precision | For response targets < 75 mg/dL, the SD is ≤<br>5.0 mg/dL, and for response targets ≥ 75<br>mg/dL, the CV is ≤ 5.0%. | Same | |
| Closed and<br>Open Vial Shelf<br>Life Stability | 18 months | Same | |
| Double Dosing | No | Same | |
| Control<br>Solutions | Aqueous, 2 levels, uses ACCU-CHEK Aviva<br>Control Solutions | Same | |
| Primary<br>Packaging | Standard flip top vial | Same | |
| Limitations of<br>Procedure | Galactose >15 mg/dL will cause overestimation<br>of blood glucose results. | Same | |
| | Lipemic Samples >1800 mg/dL | Same | |
| | Intravenous administration of ascorbic acid<br>which results in blood concentrations of<br>ascorbic acid >3 mg/dL will cause<br>overestimation of blood glucose results. | Same | |
| | If peripheral circulation is impaired, collection<br>of fresh capillary whole blood from the<br>approved sample sites is not advised as the<br>results might not be a true reflection of the<br>physiological blood glucose level. This may<br>apply in the following circumstances: severe<br>dehydration as a result of diabetic ketoacidosis<br>or due to hyperglycemic hypersmolar non-<br>ketotic syndrome, hypotension, shock,<br>decompensated heart failure, NYHA Class IV,<br>or peripheral arterial occlusive disease | Same | |

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## Summary of Technological Characteristics Compared to the Predicate
Device

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| Intended Use | The ACCU-CHEK Aviva Connect 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. The ACCU-CHEK Aviva Connect Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The ACCU-CHEK Aviva Connect 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 Connect Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. |
| | The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Connect Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. |
| | The single-patient use ACCU-CHEK Aviva Connect Blood Glucose Monitoring System will consist of: |
| | Meter: ACCU-CHEK Aviva Connect Meter Test Strip: ACCU-CHEK Aviva Plus Test Strip Controls: ACCU-CHEK Aviva Control Solutions |
| Substantial Equivalence | The ACCU-CHEK Aviva Connect system is substantially equivalent to the ACCU-CHEK Aviva Plus System (k133862). |
| Data demonstrating substantial equivalence | Performance testing on the ACCU-CHEK Aviva Connect System demonstrated that the device meets the performance requirements for its intended use. The data demonstrates that the ACCU-CHEK Aviva Connect System is substantially equivalent to the predicate device. |

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