(682 days)
K Roche/Hitachi cobas c 501 PCA-HK
No
The document describes a standard blood glucose monitoring system and a bolus advisor that calculates insulin doses based on user-entered parameters and pre-programmed settings. There is no mention of AI or ML in the device description, intended use, or performance studies. The bolus advisor's function is based on pre-defined algorithms and user-specific parameters, not learning or adaptive capabilities.
Yes.
The device measures glucose levels and calculates insulin doses for diabetes management, fulfilling a therapeutic function by aiding in the control of a disease.
No
The "Intended Use / Indications for Use" section explicitly states: "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." While it measures glucose, it's intended for monitoring, not initial diagnosis.
No
The device description explicitly lists hardware components (Accu-Chek Guide Solo diabetes manager blood glucose meter, Accu-Chek Guide Test Strips) and describes a physical process involving capillary whole blood and an electrical current. While it includes software (Accu-Chek Bolus Advisor), it is part of a larger hardware system.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"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."
This statement directly identifies the device's intended use as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
NBW, NDC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip (for fresh capillary whole blood)
Indicated Patient Age Range
Not Found (not for neonatal use)
Intended User / Care Setting
self-testing by individuals with diabetes at home, also mentions physician or healthcare professional involvement for activation of bolus calculator and programming parameters.
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification and validation testing was performed.
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.
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.
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. Linear regression analysis results: All Lots Slope 0.96, Y-Intercept 0.7189, R-squared 0.998. The results support the glucose measurement range of 20-600 mg/dL.
Interference testing: Performed, all compounds met acceptance criteria except for abnormally high concentrations (> 5 mg/dL) of ascorbic acid and xylose.
Flex Studies: Validated insensitivity of the test system to performance variation due to mechanical vibration and shock, operating conditions (temperature and humidity), altitude effects, and stability testing. Also tested samples outside measuring range, short sample detection, sample perturbation, intermittent sampling, and testing with used strips. System operated within specified ranges and displayed errors correctly when outside operating ranges.
Electromagnetic Interference and Electrical Safety: Passed testing according to IEC 61010-1, IEC 60601-1-2, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-6, and IEC 61000-4-8, and FCC 47 CFR 15 Part B.
Software: Testing and documentation for Major level of concern software was completed based on FDA guidance.
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 system accuracy was 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. Users were satisfied with ease of operation and overall performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accurate Results (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% of laboratory): (92.6%) 324 of 350 results
Most Accurate Results (within +/- 5% of laboratory): (66.6%) 233 of 350 results
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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
1
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
2
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 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.
| 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."
3
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 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 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.
| 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.
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."
4
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
5
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 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.
6
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 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.
Prescription Use (Part 21 CFR 801 Subpart D)
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 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.
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.
7
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
8
Similarities / Differences from Candidate Device to Predicate Device
| Product feature | Accu-Chek Guide Blood
Glucose monitoring
system (Predicate
Device) | Accu-Chek Guide Solo diabetes
manager Blood Glucose monitoring
system (Candidate Device) |
|----------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Indications for Use | Quantitative measurement of
glucose (sugar) in fresh capillary
whole 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 strip
vial) | Black, flip top oval vial, holds up
to 50 strips | Black flip top round vial, holds up
to 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-touch
screen |
| Backlight | Yes | Same |
| Buttons | 1 | 5 |
| Strip Ejector | Yes | Same |
| Connectivity | USB for PC connectivity and BLE
(Bluetooth Low Energy) for wireless
connectivity | Same |
| Connectivity to Insulin pump | No | Yes |
| Accu-Chek Bolus Advisor included | No | Yes |
9
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 |
10
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 Concentration
Level |
|-------|--------------------------------|
| 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."
11
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.
12
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% of | |
| laboratory) | (92.6%) 324 of 350 results |
| Most Accurate Results (within ±5% of | |
| laboratory) | (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.