ACCU-CHEK Guide Blood Glucose Monitoring System

K160944 · Roche Diabetes Care, Inc. · NBW · Aug 31, 2016 · Clinical Chemistry

Device Facts

• Record ID: K160944
• Device Name: ACCU-CHEK Guide Blood Glucose Monitoring System
• Applicant: Roche Diabetes Care, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 31, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Accu-Chek Guide Blood Glucose Monitoring System is comprised of the Accu-Chek Guide meter and the Accu-Chek Guide test strips. The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Accu-Chek Guide Control Solutions are for use with the Accu-Chek Guide Blood Glucose Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly.

Device Story

System measures glucose in capillary whole blood (fingertip, palm, upper arm) via amperometric detection on test strips. User applies blood sample to strip; meter uses FAD-GDH enzyme to convert glucose to gluconolactone, generating DC current. Meter evaluates sample and environmental conditions using AC and DC signals. Used by patients with diabetes for self-monitoring; results displayed on meter. Connectivity via USB and Bluetooth Low Energy (BLE) allows data transfer to external devices. System provides quantitative glucose values to aid in monitoring glucose control; helps patients manage diabetes. Not for diagnosis/screening. Includes control solutions to verify system performance.

Clinical Evidence

Performance testing included user accuracy studies and precision analysis. User accuracy for fingertip testing showed 100% within ±15 mg/dL for <75 mg/dL and 100% within ±20% for ≥75 mg/dL. Palm AST accuracy showed 100% within ±15 mg/dL (<75 mg/dL) and 99.7% within ±20% (≥75 mg/dL). Upper arm AST accuracy showed 100% within ±15 mg/dL (<75 mg/dL) and 98.9% within ±20% (≥75 mg/dL). Repeatability precision (within lot) CVs ranged from 2.1% to 3.5%. Reproducibility precision for control solutions showed CVs between 2.3% and 3.1%.

Technological Characteristics

Amperometric glucose test system using FAD-dependent glucose dehydrogenase (GDH) enzyme. Measurement range 20-600 mg/dL. Sample volume 0.6 μL. Connectivity: USB and Bluetooth Low Energy. Operating range: 43-113°F, 10-90% RH. Altitude up to 10,150 ft. Compliant with IEC 60601-1-2 (EMC).

Indications for Use

Indicated for single-patient use by people with diabetes to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or upper arm to monitor glucose control effectiveness. Contraindicated for diagnosis or screening of diabetes mellitus, neonatal use, critically ill patients, patients in shock, dehydrated patients, hyper-osmolar patients, or patients with cardiovascular collapse/decreased peripheral blood flow.

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 Connect Blood Glucose Monitoring System (K141867)
• Accu-Chek Aviva Controls (K043474)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a design that resembles an abstract caduceus or staff.

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

August 31, 2016

ROCHE DIABETES CARE, INC. KHONE SAYSANA REGULATORY AFFAIRS PROGRAM MANAGER 9115 HAGUE ROAD INDIANAPOLIS IN 46250-0457

Re: K160944

Trade/Device Name: ACCU-CHEK Guide Blood Glucose Monitoring System. ACCU-CHEK Guide Control Solutions Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JJX Dated: July 15, 2016 Received: July 18, 2016

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. 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 (OS) 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/ResourcesforYou/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,

# 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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#### Indications for Use

510(k) Number (if known) K160944

#### Device Name

Accu-Chek Guide Blood Glucose Monitoring System Accu-Chek Guide Control Solutions

#### Indications for Use (Describe)

The Accu-Chek Guide Blood Glucose Monitoring System is comprised of the Accu-Chek Guide meter and the Accu-Chek Guide test strips.

The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.

The Accu-Chek Guide Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes.

The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.

Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

Accu-Chek Guide Control Solutions are for use with the Accu-Chek Guide Blood Glucose Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------------|
| ☐ Prescription Use (Part 21 CFR 801 Subpart D) | ☑ Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) SUMMARY

## k160944

### 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 Diabetes Care, Inc. 9115 Hague Rd. Indianapolis, IN 46250 [phone] Contact Person: Khone Saysana Date Prepared: August 30, 2016

### 2. Device Name

| Proprietary names: | Accu-Chek Guide Blood Glucose Monitoring System |
|--------------------|-------------------------------------------------|
| | Accu-Chek Guide control solutions |

Classification name:

Glucose dehydrogenase, glucose test system (21 C.F.R. § 62.1345); Class II Single (Specified) Analyte Controls (Assayed and Unassayed) (21 CFR § 862.1660); Class I

NBW, Blood Glucose Test System, Over-the-Counter LFR, Glucose Dehydrogenase JJX, Single (Specified) Analyte Controls (Assayed and Unassayed)

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## 3. Predicate Device

Accu-Chek Aviva Connect Blood Glucose Monitoring System (k141867), concurrence received on March 3, 2015.

The Accu-Chek Aviva Controls (k043474), concurrence received on April 27, 2005.

The Accu-Chek Aviva Connect Blood Glucose Monitoring System is intended 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. 4. Device Description

The Accu-Chek Guide System consists of the following:

- Accu-Chek Guide meter
- Accu-Chek Guide test strips ●
- . Accu-Chek Guide control solutions (previously cleared in k043474)

The Accu-Chek Guide Blood Glucose Monitoring System makes use of the Accu-Chek Guide test strips, the Accu-Chek Guide meter, and the Accu-Chek Guide control solutions. This system is a single-patient use blood glucose monitoring system intended to be used to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. It should be noted that the Accu-Chek Guide control solutions are identical to the Accu-Chek Aviva control solutions that were cleared previously in k043474. The name has simply been updated to reflect their use with the Accu-Chek Guide system.

The components of the Accu-Chek Guide Blood Glucose Monitoring System are shown below:

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### The ACCU-CHEK Guide Meter

Image /page/5/Picture/1 description: The image shows a black Accu-Chek Guide meter with five different labels. Label 1 is pointing to the screen of the meter. Label 2 is pointing to the left arrow button, and label 4 is pointing to the OK button. Label 3 is pointing to the test strip port, and label 5 is pointing to the meter's ejector.

Image /page/5/Picture/2 description: The image shows two views of a gray electronic device. The view on the left shows the back of the device, and the view on the right shows the side of the device. The number 6 is visible on the back of the device.

70

00

Side View

- Front View
- 1. Display Shows results, messages, and test results stored in memory.
- 2. Back Button Returns to a previous display or field.
- 3. Up Arrow and Down Arrow Buttons Press to move between menu options or to increase or decrease numbers.
- 4. Power/Set/OK Button Turns meter on or off and sets options.
- 5. Test Strip Slot with Light Insert test strip here.

- 6. Battery Door
Flip open to replace batteries.

- 7. Micro USB Port Transfers data from the meter to a computer (PC).
- 8. Test Strip Ejector Press to remove test strip.

Back View

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Image /page/6/Figure/0 description: The image shows a collection of items, each labeled with a number from 9 to 14. Item 9 is a test strip container, while item 10 is the metallic end of a test strip. Item 11 is the yellow edge of a test strip, item 12 is a control solution bottle, item 13 is a set of batteries, and item 14 is a USB cable.

### bG Measurement Technology Description

The enzyme on the test strip, an FAD-dependent glucose dehydrogenase (GDH) expressed in A. Oryzae, converts the glucose in the blood to gluconolactone. This reaction creates a harmless DC electrical current that the meter interprets for the blood glucose result. The sample and the environmental conditions are evaluated using AC and DC signals.

### 5. Intended Use

The Accu-Chek Guide Blood Glucose Monitoring System is comprised of the Accu-Chek Guide meter and the Accu-Chek Guide test strips.

The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.

The Accu-Chek Guide Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes.

The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

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This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.

Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

Accu-Chek Guide Control Solutions are for use with the Accu-Chek Guide Blood Glucose Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly.

## 6. Substantial Equivalence

The Accu-Chek Guide system substantially equivalent to the Accu-Chek Aviva Connect system. Below is a table that provides a comparison between the Accu-Chek Guide system and its predicate device.

| | Accu-Chek Guide<br>(k160944) | Accu-Chek Aviva Connect<br>(k141867) |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Indications for<br>Use | Quantitative measurement of glucose (sugar) in fresh capillary whole blood samples. | Quantitative measurement of glucose (sugar) in fresh capillary whole blood samples. |
| Alternate Site<br>Testing | Palm and Upper arm | None |
| Enzyme | FAD-GDH | Mut. Q-GDH |
| Test Principle | Amperometric Detection | Amperometric Detection |
| Primary<br>Container (Vial) | Black, flip top oval vial, holds up to 50 strips | White, flip top vial, holds up to 50 strips |
| | Closed vial height: 51 mm<br>Width at widest point: 18.3 mm<br>Width at narrowest point:<br>15.3 mm | Closed vial height: 52.8 mm<br>Outer diameter: 30.15 mm<br>Inner diameter: 28.15 mm |
| Sample Volume | 600 nanoliters | 600 nanoliters |
| Measurement<br>Range | 20 - 600 mg/dL | 20 - 600 mg/dL |
| | Accu-Chek Guide<br>(k160944) | Accu-Chek Aviva Connect<br>(k141867) |
| Hematocrit<br>Range | 10 - 65% | 10 - 65% |
| Operating<br>Temperature<br>Range | 6 - 45 °C | 14 - 38 °C |
| Operating<br>Relative<br>Humidity Range | 10 - 90% | 10 - 80% |
| Maximum<br>Altitude | 10,150 feet | 10,000 feet |
| Underdose<br>Detection | Yes | Yes |
| Auto Control<br>Solution<br>Identification | Yes | Yes |
| Control Solutions | Aqueous, 2 Levels, cleared in<br>k043474 | Aqueous, 2 Levels, cleared in<br>k043474 |
| Strip Light | Yes | No |
| Strip Ejector | Yes | No |
| Connectivity | USB for PC connectivity and<br>BLE (Bluetooth Low Energy) for<br>wireless connectivity | USB for PC connectivity and<br>BLE (Bluetooth Low Energy) for<br>wireless connectivity |
| Coding | No | No |

## Similarities and Differences Table

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### ACCU-CHEK Guide Controls Comparison

| | Accu-Chek Guide<br>Controls<br>(k160944) | Accu-Chek Aviva<br>Controls<br>(k043474) |
|--------------------------------|-------------------------------------------------------|------------------------------------------------------------|
| Intended Use | For use with the Accu-Chek<br>Guide Monitoring System | For use with the Accu-Chek<br>Aviva Plus Monitoring System |
| Control Type | Aqueous | Aqueous |
| Ingredients/Compostion | Control solutions are identical | |
| Control Level 1<br>Target | 45 mg/dL | 45 mg/dL |
| Control Level 2<br>Target | 297 mg/dL | 307 mg/dL |
| Unopened Shelf-life<br>storage | 24 months | 24 months |

#### 7. Data demonstrating substantial equivalence

Performance testing on the Accu-Chek Guide system demonstrated that the device meets the performance requirements for its intended use. The data demonstrate that the system is substantially equivalent to the predicate device.

Below is the user performance data for the system:

Results for glucose concentrations less than 75 mg/dL

| Within ±5 mg/dL | Within ±10 mg/dL | Within ± 15 mg/dL |
|-----------------|------------------|-------------------|
| 8/12 (66.7%) | 12/12 (100%) | 12/12 (100%) |

Results for glucose concentrations greater than or equal to 75 mg/dL

| Within +5 % | Within +10 % | Within + 15 % | Within + 20 % |
|----------------|-----------------|-----------------|----------------|
| 63/108 (58.3%) | 103/108 (95.4%) | 107/108 (99.1%) | 108/108 (100%) |

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Below is the user performance Palm AST data for the system:

| Alternate Site | Within +5 mg/dL | Within +10 mg/dL | Within + 15 mg/dL |
|----------------|-----------------|------------------|-------------------|
| Palm | 8/9 (88.9%) | 9/9 (100%) | 9/9 (100%) |

Results for glucose concentrations less than 75 mg/dL

Results for glucose concentrations greater than or equal to 75 mg/dL

| Alternate<br>Site | Within $\pm$ 5 % | Within $\pm$ 10 % | Within $\pm$ 15<br>% | Within $\pm$ 20<br>% |
|-------------------|--------------------|--------------------|----------------------|----------------------|
| Palm | 175/363<br>(48.2%) | 308/363<br>(84.8%) | 356/363<br>(98.1%) | 362/363<br>(99.7%) |

Below is the user performance Upper Arm AST data for the system:

Results for glucose concentrations less than 75 mg/dL

| Alternate Site | Within $\pm$ 5 mg/dL | Within $\pm$ 10 mg/dL | Within $\pm$ 15 mg/dL |
|----------------|----------------------|-----------------------|-----------------------|
| Upper Arm | 7/10 (70%) | 10/10 (100%) | 10/10 (100%) |

Results for glucose concentrations greater than or equal to 75 mg/dL

| Alternate<br>Site | Within $\pm$ 5 % | Within $\pm$ 10 % | Within $\pm$ 15 % | Within $\pm$ 20 % |
|-------------------|--------------------|--------------------|--------------------|--------------------|
| Upper Arm | 156/355<br>(43.9%) | 281/355<br>(79.2%) | 337/355<br>(94.9%) | 351/355<br>(98.9%) |

Below is the repeatability (within lot) precision for the system:

| Blood | 1 | 2 | 3 | 4 | 5 |
|--------------|------|------|-------|-------|-------|
| N | 300 | 300 | 300 | 300 | 300 |
| Mean [mg/dL] | 40.5 | 81.7 | 132.1 | 206.7 | 330.2 |
| SD [mg/dL] | 1.4 | 2.0 | 2.8 | 5.4 | 8.6 |
| CV [%] | 3.5 | 2.4 | 2.1 | 2.6 | 2.6 |

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| Control solutions | Low | Mid | High |
|-------------------|------|-------|-------|
| N | 300 | 300 | 300 |
| Mean [mg/dL] | 44.9 | 116.6 | 297.4 |
| SD [mg/dL] | 1.4 | 2.8 | 6.8 |
| CV [%] | 3.1 | 2.4 | 2.3 |

Below is the reproducibility (intermediate or day-to-day) precision for the system: