The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is comprised of the Accu-Chek Guide Solo diabetes manager blood glucose meter, Accu-Chek Bolus Advisor and the Accu-Chek Guide test strips.

The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip. The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use), by individuals with diabetes at home as an aid in monitoring the effectiveness of glucose control.

The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is intended to be used by a single person and should not be shared.

This Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.

The Accu-Chek Bolus Advisor, as a component of the Accu-Chek Guide Solo diabetes manager, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data. Before its use, a physician or healthcare professional must activate the bolus calculator and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software. The Accu-Chek bolus advisor is intended for home use.

The Accu-Chek Guide Solo diabetes manager steers the Accu-Chek Solo micropump.

Device Description

The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system consists of the following components:

Accu-Chek Guide Solo diabetes manager
Accu-Chek Bolus Advisor
Accu-Chek Guide Test Strips

The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is a handheld device that incorporates features to aid in self-monitoring of blood glucose. The blood glucose results are displayed on the screen and stored in the meter's memory, and may also be transmitted via USB wireless communication. Our blood glucose monitoring system creates a glucose result from an amperometric reaction. Capillary whole blood from the user's fingertip reacts with the chemicals in the test strip to create a harmless electrical current in the test strip. The blood glucose meter reads the current and gives a blood glucose result.

The Accu-Chek Guide Solo diabetes manager is a remote control for the Accu-Chek Solo micropump.

AI/ML Overview

This document describes the acceptance criteria and the study proving the device, Accu-Chek Guide Solo diabetes manager blood glucose monitoring system, meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for accuracy are based on comparison to a laboratory reference method (Roche/Hitachi cobas c 501 PCA-HK) for fresh capillary whole blood samples. While explicit acceptance criteria (e.g., "must be X% within Y% of laboratory reference") are not directly stated as a separate table, the reported clinical performance data demonstrates the device's accuracy against recognized standards. The ISO 15197:2013 standard often serves as a benchmark for blood glucose monitoring systems, requiring at least 95% of results to fall within ±15 mg/dL for glucose concentrations < 100 mg/dL and within ±15% for glucose concentrations ≥ 100 mg/dL of the reference method.

Based on the provided "Clinical Performance" section, the reported device performance is as follows:

Accuracy Range vs. Laboratory Reference	Reported Device Performance
Within ±20%	99.4% (348 of 350 results)
Within ±15%	98.0% (343 of 350 results)
Within ±10%	92.6% (324 of 350 results)
Within ±5%	66.6% (233 of 350 results)

Additionally, precision and linearity performance are presented:

Performance Metric	Acceptance Criteria (Implied by standard practice/industry norms and successful submission)	Reported Device Performance
Within-Run Precision	Low %CV and low SD (typically < 5% CV for higher glucose, and low SD for lower glucose levels). Consistent with industry standards.	Glucose Level (Mean) ± SD/CV: 40 mg/dL (38.2 mg/dL) ± 1.3 mg/dL 80 mg/dL (86.6 mg/dL) ± 1.7 mg/dL 130 mg/dL (136.0 mg/dL) ± 1.9 % 200 mg/dL (221.4 mg/dL) ± 2.2 % 325 mg/dL (363.3 mg/dL) ± 2.1 %
Intermediate Precision	Low %CV and low SD. Consistent with industry standards.	Glucose Level (Mean) ± SD/CV: Low (45.8 mg/dL) ± 1.4 mg/dL Mid (119.2 mg/dL) ± 2.2 % High (307.8 mg/dL) ± 2.1 %
Linearity (R-squared)	Close to 1.0 (e.g., > 0.99)	All Lots: 0.998
Interference	No significant interference from common interfering substances at relevant concentrations.	Met acceptance criteria, with specific limitations for abnormally high concentrations (>5 mg/dL) of ascorbic acid and xylose. Labeling reflects these limitations.
Robustness (Flex Studies)	System operates within specified ranges under stress conditions and detects errors correctly.	Passed mechanical vibration and shock, operating conditions (temperature/humidity), altitude effects, and stability testing. Handled samples outside measuring range, short sample detection, sample perturbation, intermittent sampling, and used strips by operating within ranges or displaying errors.
Electromagnetic Interference (EMC) & Electrical Safety	Compliance with relevant national and international standards.	Passed IEC 61010-1, IEC 60601-1-2, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-6, IEC 61000-4-8, and FCC 47 CFR 15 Part B.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Clinical Performance Test Set: 350 individual results (implied by "348 of 350 results," "343 of 350 results," etc.).
Data Provenance: The clinical study was conducted in the United States and involved non-professional, inexperienced lay persons as intended users. The study explicitly states it uses "fresh capillary whole blood from the fingertip," indicating a prospective collection of data for this study. The precision and linearity studies used venous blood samples and linearity solutions respectively, which would typically be controlled, prospective experiments.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The ground truth for the clinical performance study was established by a "Roche/Hitachi cobas c 501 PCA-HK reference method" and "blood glucose readings obtained by trained technicians." The document does not specify the number of trained technicians or their specific qualifications (e.g., years of experience), but "trained technicians" implies expert personnel skilled in laboratory reference methods.

4. Adjudication Method for the Test Set

Not applicable. For a quantitative measurement device like a blood glucose meter, ground truth is established by a highly accurate laboratory reference instrument, not by expert adjudication of discrete classifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, with Effect Size

Not applicable. This device is a quantitative blood glucose monitoring system, not an AI-assisted diagnostic imaging device requiring MRMC studies. The human "readers" here are the lay users, and the study assesses their ability to obtain accurate readings with the device (standalone) compared to a lab reference, rather than comparing human interpretation with and without AI assistance.

6. If a Standalone Performance Study was done

Yes, a standalone performance study was done. The "Clinical Performance" section directly evaluates the accuracy of the Accu-Chek Guide Solo diabetes manager Blood Glucose monitoring system "compared to the Roche/Hitachi cobas c 501 PCA-HK reference method" when used by lay persons. This is a direct assessment of the device's performance in the hands of its intended user, without comparison to a human interpretation as an alternative, but rather against a gold standard biochemical measurement.

7. The Type of Ground Truth Used

The primary ground truth for the clinical accuracy study was laboratory reference method results, specifically from the "Roche/Hitachi cobas c 501 PCA-HK." This is a gold standard in laboratory glucose measurement. For precision and linearity, the ground truth was established by prepared blood samples (for precision) and linearity solutions (for linearity), with their precise glucose concentrations determined by highly accurate laboratory methods.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set (if any specific "training" was done in an AI/ML context, which is not directly indicated for this type of device, but rather for its software components). The precision and linearity studies used specific sample sizes:

Within-Run Precision: Ten replicate assays on ten meters using three strip lots at eight concentration levels.
Intermediate Precision: Ten replicate assays on ten meters using three strip lots at six concentration levels.
Linearity: Blood samples prepared to a hematocrit range of 36-52% and run on 36 meters using strips from three lots at eleven blood glucose concentration levels.

9. How the Ground Truth for the Training Set Was Established

Given that this is a blood glucose meter (a measurement device relying on electrochemical principles, not primarily AI/ML for its core glucose measurement), "training set" and "ground truth for training set" in the context of typical AI/ML development are not directly applicable for the glucose measurement component. The "training" for such a device is in its chemical and electrical calibration during manufacturing and design, which is validated through the precision, linearity, and accuracy studies using known concentration materials and reference methods.

For the "Accu-Chek Bolus Advisor" software component, which is new, the document states: "Before its use, a physician or healthcare professional must activate the bolus calculator and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software." This implies that the 'ground truth' or calibration for this specific software functionality is based on individual patient parameters set by a healthcare professional, rather than a general training dataset. The software "testing and documentation for Major level of concern software was completed," indicating standard software validation processes, which would include testing against defined functional requirements and potentially simulated or real patient input/output scenarios based on established medical algorithms. However, no specifics about data used for training this software are provided in the context of the main glucose measurement device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

August 10, 2023

Roche Diabetes Care, Inc Wolfgang Handel Regulatory Affairs Project Lead 9115 Hague Road Indianapolis, IN 46250-0457

Re: K213131

Trade/Device Name: Accu-Chek Guide Solo diabetes manager blood glucose monitoring system Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: February 22, 2023 Received: February 22, 2023

Dear Wolfgang Handel:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Joshua Balsam -S

Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213131

Device Name

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system

Indications for Use (Describe)

The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is intended to be used by a single person and should not be shared.

This Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K213131

Device Name

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system

Indications for Use (Describe)

The Accu-Chek Guide Solo diabetes manager steers the Accu-Chek Solo micropump.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K213131 – Accu-Chek Guide Solo diabetes manager blood glucose monitoring system 510(k) Summary

Submitter Details [21 CFR 807.92(a)(1)]

Applicant Name:	Roche Diabetes Care, Inc.
Applicant Address:	9115 Hague Road Indianapolis, IN 46250-0457;United States
Applicant Contact Telephone:	+49 621 759 8331
Applicant Contact:	Mr. Wolfgang Handel
Correspondent Name	Roche Diabetes Care GmbH
Correspondent Address	9115 Hague Road Indianapolis, IN 46250-0457;United States
Correspondent Contact Telephone	+49 621 759 8331
Correspondent Contact	Mr. Wolfgang Handel
Correspondent Contact Email:	wolfgang.handel@roche.com
Applicant Contact Email	wolfgang.handel@roche.com

Device Name [21 CFR 807.92(a)(2)]

Device Trade Name: Accu-Chek Guide Solo diabetes manager blood glucose monitoring system Common Name: Glucose test system Classification Names: Blood Glucose Test System, Over the Counter; Glucose dehydrogenase; Calculator, Drug Dose Regulation Number: 862.1345, 868.1890 Class II Product Code: NBW, NDC

Legally Marketed Predicate Devices [21 CFR 807.92(a)(3)[

Predicate #: K160944 Predicate Trade Name: Accu-Chek Guide Blood Glucose Monitoring System Product Code: NBW

Predicate #: K150910 Predicate Trade Name: Accu-Chek Connect Diabetes Management App Product Code: NDC

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Device Description Summary [21 CFR 807.92(a)(4)]

The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system consists of the following components:

Accu-Chek Guide Solo diabetes manager
Accu-Chek Bolus Advisor
Accu-Chek Guide Test Strips

The Accu-Chek Guide Solo diabetes manager is a remote control for the Accu-Chek Solo micropump.

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Intended Use/Indications for Use [21 CFR 807.92(a)(5)]

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

The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is intended to be used by a single person and should not be shared.

This Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.

Prescription Use (Part 21 CFR 801 Subpart D)

Indications for Use Comparison [21 CFR 807.92(a)(5)]

The indications for use of the candidate device are the same as the predicate with the exception that the Alternate Site Testing (AST) claim will not be made with the candidate device. And the predicate device was not able to steer an insulin pump.

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Technological Comparison [21 CFR 807.92(a)(6)]

The Accu-Chek Guide Solo diabetes manager Blood Glucose monitoring system measurement engine, measurement principle, and control solutions are the same as those used in the Accu-Chek Guide Blood Glucose monitoring system. The candidate and predicate devices share the same technological characteristics including design, material, chemical composition, principle of operation.

The Accu-Chek Guide Solo diabetes manager Blood Glucose monitoring system differs from the cleared Accu-Chek Guide Blood Glucose monitoring system as follows:

Guide Blood Glucose monitoring system: Palm, Forearm, Upper Arm;
Accu-Chek Guide Solo diabetes manager Blood Glucose monitoring system: No AST claim
Guide Blood Glucose monitoring system: Dot Matrix Display;
Accu-Chek Guide Solo diabetes manager Blood Glucose monitoring system: Capacitive color LCD multi-touch screen
Guide Blood Glucose monitoring system: 1 Button;
Accu-Chek Guide Solo diabetes manager Blood Glucose monitoring system: 5 Buttons

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Similarities / Differences from Candidate Device to Predicate Device

Product feature	Accu-Chek Guide BloodGlucose monitoringsystem (PredicateDevice)	Accu-Chek Guide Solo diabetesmanager Blood Glucose monitoringsystem (Candidate Device)
Indications for Use	Quantitative measurement ofglucose (sugar) in fresh capillarywhole blood samples.	Same
Alternate Site Testing	Palm, Forearm, and Upper Arm	No AST Claim
Enzyme	FAD-GDH	Same
Test Principle	Amperometric Detection	Same
Primary Container (test stripvial)	Black, flip top oval vial, holds upto 50 strips	Black flip top round vial, holds upto 50 strips
Sample Volume	600 nanoliters	Same
Sample Test Time	≤5 second	Same
Measurement Range	20-600 mg/dL	Same
Units of Measurement	mg/dL	Same
Hematocrit Range	10-65%	Same
Operating Temperature Range	4-45 °C	Same
Operating Relative Humidity Range	10-90%	Same
Maximum Altitude	10,150 feet	9842 feet
Underdose Detection	Yes	Same
Batteries	2 CR2032	Rechargeable lithium polymer battery
Display	Dot Matrix LCD	Capacitive color LCD multi-touchscreen
Backlight	Yes	Same
Buttons	1	5
Strip Ejector	Yes	Same
Connectivity	USB for PC connectivity and BLE(Bluetooth Low Energy) for wirelessconnectivity	Same
Connectivity to Insulin pump	No	Yes
Accu-Chek Bolus Advisor included	No	Yes

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Non-Clinical & Clinical Testing Summary and Conclusions [21 CFR 807.92(b)]

Design verification and validation testing was performed to ensure the Accu-Chek Guide Solo diabetes manager Blood Glucose monitoring system met design specifications and requirements. Testing is summarized below:

Within-Run Precision Evaluation

Ten replicate assays were each run on ten Accu-Chek Guide Solo diabetes manager meters using three strip lots. Venous blood samples at eight concentration levels were used in the testing. The results are summarized below.

	Glucose Level	Mean	Standard Deviation or % CV
1	(40 mg/dL)	38.2 mg/dL	1.3 mg/dL
2	(80 mg/dL)	86.6 mg/dL	1.7 mg/dL
3	(130 mg/dL)	136.0 mg/dL	1.9
4	(200 mg/dL)	221.4 mg/dL	2.2
5	(325 mg/dL)	363.3 mg/dL	2.1

Intermediate Precision Evaluation

Ten replicate assays were each run on ten Accu-Chek Guide Solo diabetes manager using three strip lots. Linearity solutions at six concentration levels were used in the testing. The results are summarized below.

Glucose Level	Mean	Standard Deviation or % CV
Low	45.8 mg/dL	1.4 mg/dL
Mid	119.2 mg/dL	2.2 mg/dL
High	307.8 mg/dL	2.1

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Linearity Evaluation

Blood samples were prepared to a hematocrit range of 36-52% and were run on 36 meters using strips from three lots. Samples were prepared at eleven blood glucose concentration levels as shown below.

Level	Glucose ConcentrationLevel
1	1-9 mg/dL
2	15-25 mg/dL
3	30-50 mg/dL
4	51-70 mg/dL
5	80-100 mg/dL
6	110-130 mg/dL
7	135-165 mg/dL
8	175-225 mg/dL
9	275-325 mg/dL
10	420-480 mg/dL
11	550-650 mg/dL

Linear regression analysis results are shown below.

Strip Lot	Slope	Y-Intercept	R-squared
All Lots	0.96	0.7189	0.998

The results of the linearity study support the glucose measurement range of 20-600 mg/dL for the Accu-Chek Guide Solo diabetes manager Blood Glucose monitoring system.

Interference

Interference testing was performed and all compounds met the acceptance criteria with the exception of abnormally high concentrations (> 5 mg/dL) of ascorbic acid and xylose. The labeling contains the following limitations:

" Abnormally high concentrations (greater than 5 mg/dL) of ascorbic acid (vitamin C) may cause inaccurate results. High-dose vitamin C therapy that would result in abnormally high concentrations is typically prescribed by your healthcare professional. If you are not sure if this applies to you, please check

with your healthcare professional."

"Do not use during or soon after xylose absorption testing since xylose may cause inaccurate results. Xylose absorption testing is performed under the supervision of a healthcare professional. Ask your healthcare professional how long to wait after xylose testing before performing a blood glucose test."

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Flex Studies

Flex studies were used to validate the insensitivity of the test system to performance variation due to factors that may contribute to erroneous results when used in home use settings rather than in laboratory or professional healthcare settings. The robustness of the system was validated through mechanical vibration and shock testing, operating conditions (temperature and humidity) testing, altitude effects testing, and stability testing. Additional sources of error that were tested included samples outside the measuring range, short sample detection, sample perturbation, intermittent sampling, and testing with used strips. In all of the tests, the system operated within its specified operating ranges even under stress conditions, and errors were correctly displayed when outside the meter's operating ranges.

Electromagnetic Interference and Electrical Safety

The system passed electrical and safety testing according to national and international standards including IEC 61010-1, IEC 60601-1-2, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-6, and IEC 61000-4-8.

The system passed EMC testing to national and international standards including IEC 60601-1-2, and FCC 47 CFR 15 Part B.

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Software

Based on the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005, testing and documentation for Major level of concern software was completed.

Clinical Performance

A clinical (user evaluation) study was conducted with Accu-Chek Guide Solo diabetes manager Blood Glucose monitoring system in the intended user population, i.e. lay persons who perform self-testing using capillary whole blood, in the United States. The study data were presented evaluating the system accuracy of the Accu-Chek Guide Solo diabetes manager Blood Glucose monitoring system compared to the Roche/Hitachi cobas c 501 PCA-HK reference method. Study results indicated that non-professional, inexperienced lay persons were able to obtain sufficiently accurate blood glucose readings when using the Accu-Chek Guide Solo diabetes manager Blood Glucose monitoring system compared to the comparator Roche/Hitachi cobas c 501 PCA-HK blood glucose readings obtained by trained technicians. In addition, the participating lay persons were questioned and responded as satisfied with the ease of operation by following the Instructions for Use in the User Guide and the overall performance of the Accu-Chek Guide Solo diabetes manager blood glucose monitoring system. Users were able to achieve the following level of accuracy compared to the reference method:

(within ±20% of laboratory)	(99.4%) 348 of 350 results
Accurate Results (within ±15% of laboratory)	(98.0%) 343 of 350 results
More Accurate Results (within ±10% oflaboratory)	(92.6%) 324 of 350 results
Most Accurate Results (within ±5% oflaboratory)	(66.6%) 233 of 350 results

Conclusions

The results of nonclinical and clinical performance testing demonstrate that the candidate device has a substantially equivalent safety and effectiveness profile to the predicate device and should perform as intended in the specified use conditions as well as the predicate device per required standards.

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.