K Number
K160944
Device Name
ACCU-CHEK Guide Blood Glucose Monitoring System
Date Cleared
2016-08-31

(148 days)

Product Code
Regulation Number
862.1345
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
More Information

Not Found

No
The document describes a standard blood glucose monitoring system and does not mention any AI or ML components or capabilities.

No.
The device is intended to monitor glucose levels, not to provide therapy or treatment. It aids in monitoring the effectiveness of glucose control.

Yes

The "Intended Use / Indications for Use" section states: "The Accu-Chek Guide Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes." It further clarifies, "This system is not for use in diagnosis or screening of diabetes mellitus...", indicating it is for monitoring, which falls under diagnostic purposes without being for initial diagnosis.

No

The device description explicitly states that the system consists of a meter, test strips, and control solutions, which are all hardware components.

Yes, the Accu-Chek Guide Blood Glucose Monitoring System is an IVD (In Vitro Diagnostic).

Here's why:

  • Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Accu-Chek Guide Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes."
  • Nature of the Test: The system measures glucose in a biological sample (blood) outside of the body ("in vitro") to provide information about a person's health status (glucose levels). This is the core definition of an in vitro diagnostic device.
  • Purpose: It is used as an "aid in monitoring the effectiveness of glucose control," which is a diagnostic purpose, even though it's not for initial diagnosis or screening.

N/A

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

NBW, LFR, JJX

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

fingertip, palm, and upper arm

Indicated Patient Age Range

Not Found

Intended User / Care Setting

single-patient use by people with diabetes. Over-The-Counter Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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: 8/12 (66.7%)
Within ±10 mg/dL: 12/12 (100%)
Within ± 15 mg/dL: 12/12 (100%)

Results for glucose concentrations greater than or equal to 75 mg/dL
Within +5 %: 63/108 (58.3%)
Within +10 %: 103/108 (95.4%)
Within + 15 %: 107/108 (99.1%)
Within + 20 %: 108/108 (100%)

Below is the user performance Palm AST data for the system:
Results for glucose concentrations less than 75 mg/dL
Alternate Site: Palm
Within +5 mg/dL: 8/9 (88.9%)
Within +10 mg/dL: 9/9 (100%)
Within + 15 mg/dL: 9/9 (100%)

Results for glucose concentrations greater than or equal to 75 mg/dL
Alternate Site: Palm
Within ± 5 %: 175/363 (48.2%)
Within ± 10 %: 308/363 (84.8%)
Within ± 15 %: 356/363 (98.1%)
Within ± 20 %: 362/363 (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: Upper Arm
Within ± 5 mg/dL: 7/10 (70%)
Within ± 10 mg/dL: 10/10 (100%)
Within ± 15 mg/dL: 10/10 (100%)

Results for glucose concentrations greater than or equal to 75 mg/dL
Alternate Site: Upper Arm
Within ± 5 %: 156/355 (43.9%)
Within ± 10 %: 281/355 (79.2%)
Within ± 15 %: 337/355 (94.9%)
Within ± 20 %: 351/355 (98.9%)

Below is the repeatability (within lot) precision for the system:
Blood
N: 300 for each of 5 samples
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

Control solutions
N: 300 for each of 3 levels
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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

See "Summary of Performance Studies" for Within-percentage and Within-mg/dL values.
Repeatability (within lot) precision: Mean, SD, and CV.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 862.1345 Glucose test system.

(a)
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.(b)
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.

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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.

1

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 (317) 521-7593 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:

5

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

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Side View

  • Front View

    1. Display Shows results, messages, and test results stored in memory.
    1. Back Button Returns to a previous display or field.
    1. Up Arrow and Down Arrow Buttons Press to move between menu options or to increase or decrease numbers.
    1. Power/Set/OK Button Turns meter on or off and sets options.
    1. Test Strip Slot with Light Insert test strip here.
    1. Battery Door
      Flip open to replace batteries.
    1. Micro USB Port Transfers data from the meter to a computer (PC).
    1. 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
(K160944) | Accu-Chek Aviva Connect
(K141867) |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Indications for
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
Testing | Palm and Upper arm | None |
| Enzyme | FAD-GDH | Mut. Q-GDH |
| Test Principle | Amperometric Detection | Amperometric Detection |
| Primary
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
Width at widest point: 18.3 mm
Width at narrowest point:
15.3 mm | Closed vial height: 52.8 mm
Outer diameter: 30.15 mm
Inner diameter: 28.15 mm |
| Sample Volume | 600 nanoliters | 600 nanoliters |
| Measurement
Range | 20 - 600 mg/dL | 20 - 600 mg/dL |
| | Accu-Chek Guide
(K160944) | Accu-Chek Aviva Connect
(K141867) |
| Hematocrit
Range | 10 - 65% | 10 - 65% |
| Operating
Temperature
Range | 6 - 45 °C | 14 - 38 °C |
| Operating
Relative
Humidity Range | 10 - 90% | 10 - 80% |
| Maximum
Altitude | 10,150 feet | 10,000 feet |
| Underdose
Detection | Yes | Yes |
| Auto Control
Solution
Identification | Yes | Yes |
| Control Solutions | Aqueous, 2 Levels, cleared in
K043474 | Aqueous, 2 Levels, cleared in
K043474 |
| Strip Light | Yes | No |
| Strip Ejector | Yes | No |
| Connectivity | USB for PC connectivity and
BLE (Bluetooth Low Energy) for
wireless connectivity | USB for PC connectivity and
BLE (Bluetooth Low Energy) for
wireless connectivity |
| Coding | No | No |

Similarities and Differences Table

8

9

ACCU-CHEK Guide Controls Comparison

| | Accu-Chek Guide
Controls
(K160944) | Accu-Chek Aviva
Controls
(K043474) |
|--------------------------------|-------------------------------------------------------|------------------------------------------------------------|
| Intended Use | For use with the Accu-Chek
Guide Monitoring System | For use with the Accu-Chek
Aviva Plus Monitoring System |
| Control Type | Aqueous | Aqueous |
| Ingredients/Compostion | Control solutions are identical | |
| Control Level 1
Target | 45 mg/dL | 45 mg/dL |
| Control Level 2
Target | 297 mg/dL | 307 mg/dL |
| Unopened Shelf-life
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/dLWithin ±10 mg/dLWithin ± 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 SiteWithin +5 mg/dLWithin +10 mg/dLWithin + 15 mg/dL
Palm8/9 (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
Site | Within $\pm$ 5 % | Within $\pm$ 10 % | Within $\pm$ 15
% | Within $\pm$ 20
% |
|-------------------|--------------------|--------------------|----------------------|----------------------|
| Palm | 175/363
(48.2%) | 308/363
(84.8%) | 356/363
(98.1%) | 362/363
(99.7%) |

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

Results for glucose concentrations less than 75 mg/dL

Alternate SiteWithin $\pm$ 5 mg/dLWithin $\pm$ 10 mg/dLWithin $\pm$ 15 mg/dL
Upper Arm7/10 (70%)10/10 (100%)10/10 (100%)

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

| Alternate

SiteWithin $\pm$ 5 %Within $\pm$ 10 %Within $\pm$ 15 %Within $\pm$ 20 %
Upper Arm156/355
(43.9%)281/355
(79.2%)337/355
(94.9%)351/355
(98.9%)

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

Blood12345
N300300300300300
Mean [mg/dL]40.581.7132.1206.7330.2
SD [mg/dL]1.42.02.85.48.6
CV [%]3.52.42.12.62.6

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Control solutionsLowMidHigh
N300300300
Mean [mg/dL]44.9116.6297.4
SD [mg/dL]1.42.86.8
CV [%]3.12.42.3

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