GLUCOSE TEST SYSTEM

K113137 · Roche Diagnostics · NBW · Jan 6, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113137
• Device Name: GLUCOSE TEST SYSTEM
• Applicant: Roche Diagnostics
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 6, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ACCU-CHEK® Nano SmartView 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 or palm. The ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The ACCU-CHEK® Nano SmartView 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® Nano SmartView 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® SmartView Test Strips are for use with the ACCU-CHEK® Nano Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.

Device Story

System measures glucose in fresh capillary whole blood (fingertip/palm) via electrochemical test strips. User inserts strip into meter; device applies AC current to detect sample sufficiency; applies AC voltages at four frequencies to assess sample type, temperature, and quality; applies DC voltage to measure glucose-proportional current. AC and DC data combined for hematocrit and temperature-compensated glucose result. Used at home by patients for diabetes management. Meter features embedded strip lot code (no physical code key required). Output displayed on meter screen to inform patient of glucose levels for diabetes control monitoring.

Clinical Evidence

Bench testing only. Validation performed on device durability and performance after 260 cleaning and disinfection cycles using Super Sani-Cloth Germicidal Disposable Wipes to simulate 5 years of single-patient use. No clinical data provided.

Technological Characteristics

Electrochemical glucose monitoring. Dimensions: 69 x 43 x 20 mm. No-coding technology. Validated for chemical compatibility with Super Sani-Cloth Germicidal Disposable Wipes (EPA #9480-4).

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

• Roche ACCU-CHEK Aviva Plus Blood Glucose Monitoring System (k101299)

Submission Summary (Full Text)

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K 113/37

JAN - 6 2012

# 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. |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: October 18, 2011 |
| 2) Device name | Proprietary name:<br>ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System<br>Meter: ACCU-CHEK® Nano Meter<br>Test Strip: ACCU-CHEK® SmartView Test Strip<br>Controls: ACCU-CHEK® SmartView Control Solutions<br><br>Classification name: Glucose dehydrogenase, glucose test system (21 C.F.R. § 862.1345)<br><br>NBW, Blood Glucose Test System, Over-the-Counter<br>LFR, Glucose Dehydrogenase |
| 3) Predicate device | ACCU-CHEK® Aviva Plus System (K101299) |

Continued on next page

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## 510(k) Summary, Continued

### 4) Device Description

・・・・

The ACCU-CHEK® Nano meter was developed to utilize the ACCU-CHEK® Aviva Plus test system's technology and performance characteristics. The ACCU-CHEK® Nano meter designers took the measurement components of the ACCU-CHEK® Aviva Plus system, slightly changed the firmware and hardware supporting the new user interface and housing and embedded/programmed the strip lot code information within the meter so a physical code key or code key port are no longer used.

The ACCU-CHEK ® SmartView test strip is a No Code Freedom 2 Chemistry test strip which shares the same scientific technology as the predicate device, the ACCU-CHEK® Aviva Plus test strips. The instrument's measurement method is not modified as a part of this test strip modification project.

When an ACCU-CHEK® SmartView test strip is inserted into the ACCU-CHEK® Nano meter, a small alternating current (AC) is applied until the application of blood causes a spike in the conductivity to be observed at the measurement and sample-sufficiency electrodes – both are used to assure an adequate sample has been applied.

The instrument then applies a series of AC voltages at four frequencies and reads the AC responses. These carry information about the sample type and environmental temperature; they also allow the system to perform various internal quality checks.

After the AC measures are completed, a small (DC) voltage is applied and current is observed which is proportionate to the glucose. The AC and DC information are then combined to provide a hematocrit and temperature compensated glucose result.

Continued on next page

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## 510(k) Summary, Continued

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

> The ACCU-CHEK® Nano SmartView 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® Nano SmartView 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® SmartView Test Strips are for use with the ACCU-CHEK® Nano Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.

The single-patient use ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System will consist of:

> Meter: ACCU-CHEK® Nano Meter Test Strip: ACCU-CHEK® SmartView Test Strip Controls: ACCU-CHEK® SmartView Control Solutions

| 6) Substantial<br>equivalence | The modified ACCU-CHEK® Nano SmartView Blood Glucose Monitoring<br>System is substantially equivalent to the ACCU-CHEK® Aviva Plus System<br>(K101299). |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7) Data<br>demonstrating<br>substantial<br>equivalence | Performance testing on the ACCU-CHEK® Nano SmartView Blood Glucose<br>Monitoring System demonstrated that the device meets the performance<br>requirements for its intended use. The data demonstrates that the test strip is<br>substantially equivalent to the predicate device. |

0012

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized design of a human figure, with three overlapping profiles facing to the right. The design is simple and modern, with bold lines and a sense of movement.

10903 New Hampshire Avenue Silver Spring, MD 20993

Roche Diagnostics c/o Khonesavanh Saysana 9115 Hague Road Indianapolis, Indiana 46250-0416

JAN - 6 2012

Re: k113137 Trade Name: Roche ACCU-CHEK Nano SmartView Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW. LFR Dated: December 7, 2011 Received: December 8, 2011

Dear Mr. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (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 (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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#### Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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/Medical Devices/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/ResourcesforYou/Industry/default.htm

Sincerely yours,

signature

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

Enclosure

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### Indications for Use Statement

从113137 Device Name: ACCU-CHEK Nano SmartView Blood Glucose Monitoring System

Indications for Use:

The ACCU-CHEK Nano SmartView 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 or palm. The ACCU-CHEK Nano SmartView Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The ACCU-CHEK Nano SmartView 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 Nano Smartview 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* SmartView Test Strips are for use with the ACCU-CHEK Nano Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.

Prescription Use _ (Part 21 CFR 801 Subpart D) AND

Over-The-Counter Use __ XX (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 Diagnostic Devices (OIVD)

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k"313

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