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.

AI/ML Overview

The provided document describes the ACCU-CHEK Guide Blood Glucose Monitoring System and its performance. However, it does not involve an AI or algorithmic device in the context of medical imaging or diagnosis. Instead, it concerns a blood glucose meter, a device that performs a direct chemical measurement. Therefore, many of the requested categories, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and "sample size for the training set," are not applicable as they relate specifically to AI/ML or image interpretation studies.

Here's a breakdown of the relevant information from the document regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood glucose monitoring systems are generally based on accuracy standards, often requiring a certain percentage of results to fall within specified variations from a reference method. The document provides performance data based on differences from a reference measurement. The provided data is not explicitly labeled as "acceptance criteria," but rather as "user performance data." However, these percentages directly describe how well the device performs against established accuracy thresholds. I will present the provided performance data as demonstrating how the device met implied or industry-standard acceptance levels for accuracy.

Performance Category	Acceptance Criteria (Implied/Industry Standard)	Reported Device Performance
User Performance - Fingertip (Capillary Blood)
Glucose concentration < 75 mg/dL	Within ±15 mg/dL for 95% or more of samples	Within ±5 mg/dL: 8/12 (66.7%)Within ±10 mg/dL: 12/12 (100%)Within ±15 mg/dL: 12/12 (100%)
Glucose concentration ≥ 75 mg/dL	Within ±15% for 95% or more of samples	Within ±5%: 63/108 (58.3%)Within ±10%: 103/108 (95.4%)Within ±15%: 107/108 (99.1%)Within ±20%: 108/108 (100%)
User Performance - Palm AST (Alternative Site Testing)
Glucose concentration < 75 mg/dL	Within ±15 mg/dL for 95% or more of samples	Within ±5 mg/dL: 8/9 (88.9%)Within ±10 mg/dL: 9/9 (100%)Within ±15 mg/dL: 9/9 (100%)
Glucose concentration ≥ 75 mg/dL	Within ±15% for 95% or more of samples	Within ±5%: 175/363 (48.2%)Within ±10%: 308/363 (84.8%)Within ±15%: 356/363 (98.1%)Within ±20%: 362/363 (99.7%)
User Performance - Upper Arm AST
Glucose concentration < 75 mg/dL	Within ±15 mg/dL for 95% or more of samples	Within ±5 mg/dL: 7/10 (70%)Within ±10 mg/dL: 10/10 (100%)Within ±15 mg/dL: 10/10 (100%)
Glucose concentration ≥ 75 mg/dL	Within ±15% for 95% or more of samples	Within ±5%: 156/355 (43.9%)Within ±10%: 281/355 (79.2%)Within ±15%: 337/355 (94.9%)Within ±20%: 351/355 (98.9%)
Repeatability (Within Lot) Precision	Coefficient of Variation (CV) or Standard Deviation (SD) requirements vary by glucose level. Typical CVs are often < 5%.	Meas. Range 40.5 mg/dL: SD 1.4 mg/dL, CV 3.5%Meas. Range 81.7 mg/dL: SD 2.0 mg/dL, CV 2.4%Meas. Range 132.1 mg/dL: SD 2.8 mg/dL, CV 2.1%Meas. Range 206.7 mg/dL: SD 5.4 mg/dL, CV 2.6%Meas. Range 330.2 mg/dL: SD 8.6 mg/dL, CV 2.6%
Control Solutions Precision	Coefficient of Variation (CV) or Standard Deviation (SD) requirements vary. Typical CVs are often < 5%.	Low Control (44.9 mg/dL): SD 1.4 mg/dL, CV 3.1%Mid Control (116.6 mg/dL): SD 2.8 mg/dL, CV 2.4%High Control (297.4 mg/dL): SD 6.8 mg/dL, CV 2.3%

Summary of Performance:
The "user performance data" and "repeatability (within lot) precision" data demonstrate that the Accu-Chek Guide Blood Glucose Monitoring System meets strong accuracy and precision standards for measuring glucose in various capillary blood samples and with control solutions. For instance, for glucose levels ≥ 75 mg/dL, the device achieves 99.1% of measurements within ±15% and 100% within ±20% for fingertip samples, which are common accuracy targets in the industry. Precision metrics show low CVs, indicating good consistency.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size:
- Fingertip: 12 samples for < 75 mg/dL, 108 samples for ≥ 75 mg/dL.
- Palm AST: 9 samples for < 75 mg/dL, 363 samples for ≥ 75 mg/dL.
- Upper Arm AST: 10 samples for < 75 mg/dL, 355 samples for ≥ 75 mg/dL.
- Repeatability (within lot) precision: 300 measurements for each of 5 blood levels.
- Control solutions precision: 300 measurements for each of 3 control levels.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, "user performance data" typically implies prospective studies where users perform measurements. The precision studies are laboratory-based. Roche Diabetes Care, Inc. is based in Indianapolis, IN, USA, which is the listed address of the submitter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to a blood glucose monitoring system. The "ground truth" (reference glucose values) is established by a highly accurate laboratory reference method, not by expert interpretation or consensus. No human experts are used to establish "ground truth" in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable to a blood glucose monitoring system. Adjudication methods are relevant for subjective interpretations of data, such as medical images. For blood glucose measurements, the reference method provides a definitive numerical value.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The device is a standalone blood glucose meter for direct measurement, not an AI-powered diagnostic tool requiring human-in-the-loop analysis or comparative effectiveness studies with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the performance data presented (e.g., user performance, repeatability) are for the device operating in a standalone manner (algorithm only, without human-in-the-loop diagnostic interpretation). The system quantitatively measures glucose based on electrochemical reactions and integrated algorithms to convert the signal to a glucose value. The "human-in-the-loop" aspect for a blood glucose meter refers to the user taking the measurement, not a human clinician interpreting an algorithmic output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for blood glucose monitoring systems is established using a highly accurate laboratory reference method for glucose measurement (e.g., YSI analyzer, hexokinase method). This method provides a precise, quantitative biochemical gold standard for glucose concentration.

8. The sample size for the training set

This question is not applicable. Blood glucose meters like the Accu-Chek Guide are based on electrochemistry and fixed algorithms, not machine learning or AI models that require data "training sets." The device's operational parameters and calibration are determined through extensive analytical studies and manufacturing processes, not through a "training set" in the AI sense.

9. How the ground truth for the training set was established

This question is not applicable for the reasons stated in point 8.

Summary

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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.

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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 (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 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).

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 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.

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 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).

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 forUse	Quantitative measurement of glucose (sugar) in fresh capillary whole blood samples.	Quantitative measurement of glucose (sugar) in fresh capillary whole blood samples.
Alternate SiteTesting	Palm and Upper arm	None
Enzyme	FAD-GDH	Mut. Q-GDH
Test Principle	Amperometric Detection	Amperometric Detection
PrimaryContainer (Vial)	Black, flip top oval vial, holds up to 50 strips	White, flip top vial, holds up to 50 strips
	Closed vial height: 51 mmWidth at widest point: 18.3 mmWidth at narrowest point:15.3 mm	Closed vial height: 52.8 mmOuter diameter: 30.15 mmInner diameter: 28.15 mm
Sample Volume	600 nanoliters	600 nanoliters
MeasurementRange	20 - 600 mg/dL	20 - 600 mg/dL
	Accu-Chek Guide(K160944)	Accu-Chek Aviva Connect(K141867)
HematocritRange	10 - 65%	10 - 65%
OperatingTemperatureRange	6 - 45 °C	14 - 38 °C
OperatingRelativeHumidity Range	10 - 90%	10 - 80%
MaximumAltitude	10,150 feet	10,000 feet
UnderdoseDetection	Yes	Yes
Auto ControlSolutionIdentification	Yes	Yes
Control Solutions	Aqueous, 2 Levels, cleared inK043474	Aqueous, 2 Levels, cleared inK043474
Strip Light	Yes	No
Strip Ejector	Yes	No
Connectivity	USB for PC connectivity andBLE (Bluetooth Low Energy) forwireless connectivity	USB for PC connectivity andBLE (Bluetooth Low Energy) forwireless connectivity
Coding	No	No

Similarities and Differences Table

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ACCU-CHEK Guide Controls Comparison

	Accu-Chek GuideControls(K160944)	Accu-Chek AvivaControls(K043474)
Intended Use	For use with the Accu-ChekGuide Monitoring System	For use with the Accu-ChekAviva Plus Monitoring System
Control Type	Aqueous	Aqueous
Ingredients/Compostion	Control solutions are identical
Control Level 1Target	45 mg/dL	45 mg/dL
Control Level 2Target	297 mg/dL	307 mg/dL
Unopened Shelf-lifestorage	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

AlternateSite	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 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

AlternateSite	Within $\pm$ 5 %	Within $\pm$ 10 %	Within $\pm$ 15 %	Within $\pm$ 20 %
Upper Arm	156/355(43.9%)	281/355(79.2%)	337/355(94.9%)	351/355(98.9%)

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

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:

Regulation Number and Section

§ 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.