Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
Device Facts
| Record ID | K213131 |
|---|---|
| Device Name | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system |
| Applicant | Roche Diabetes Care GmbH |
| Product Code | NBW · Clinical Chemistry |
| Decision Date | Aug 10, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
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.
Device Story
System comprises blood glucose meter, test strips, and bolus advisor software; acts as remote control/interface for Accu-Chek Solo micropump. Meter uses amperometric assay (GDH-FAD enzyme) on capillary blood; evaluates sample/environment via AC/DC signals. Bolus advisor calculates insulin/carbohydrate doses based on physician-programmed parameters (target glucose, ratios, sensitivity). Used at home by single patient. Healthcare provider programs bolus settings; patient uses meter for glucose monitoring and pump control. Output displayed on capacitive color touch screen; aids in glucose control monitoring and insulin delivery management.
Clinical Evidence
Clinical user study (n=350) with lay persons performing self-testing compared to Roche/Hitachi cobas c 501 PCA-HK reference method. Accuracy results: 99.4% of results within ±20% of laboratory reference, 98.0% within ±15%, 92.6% within ±10%, and 66.6% within ±5%. Bench testing included precision, linearity, interference, and flex studies (vibration, shock, environmental, altitude).
Technological Characteristics
Amperometric glucose measurement using GDH-FAD enzyme. Rechargeable lithium polymer battery. Capacitive color LCD multi-touch screen. Connectivity: wireless control for Accu-Chek Solo micropump. Factory calibrated. Compliant with IEC 60601-1, IEC 60601-1-2, and ISO 14971. Software life cycle per IEC 62304.
Indications for Use
Indicated for individuals with diabetes for quantitative measurement of glucose in fresh capillary whole blood from the fingertip and for insulin dose/carbohydrate intake calculation. Not for use in diagnosis/screening of diabetes, neonatal use, or for critically ill, shock, dehydrated, or hyperosmolar patients.
Regulatory Classification
Identification
A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Special Controls
*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Predicate Devices
- Accu-Chek Guide Blood Glucose Monitoring System (K160944)
- Accu-Chek Connect Diabetes Management App (K150910)
Related Devices
- K142089 — ACCU-CHEK AVIVA EXPERT SYSTEM · Roche Diagnostics Corporation · Dec 17, 2014
- K170241 — GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System · All Medicus Co., Ltd. · Oct 13, 2017
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY AND INSTRUMENT
## I Background Information:
A 510(k) Number
K213131
B Applicant
Roche Diabetes Care, Inc.
C Proprietary and Established Names
Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NBW | Class II | 21 CFR 862.1345
Glucose Test System | CH – Clinical Chemistry |
| NDC | Class II | 21 CFR 868.1890 -
Predictive Pulmonary-Function Value Calculator | CH – Clinical Chemistry |
## II Submission/Device Overview:
A Purpose for Submission:
New device
B Measurand:
Glucose in capillary whole blood drawn from the fingertip
C Type of Test:
Quantitative amperometric assay, glucose dehydrogenase (GDH-FAD)
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for Use:
OTC 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.
Rx 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 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.
C Special Conditions for Use Statement(s):
Rx and OTC
For single patient use only
Not for use on critically ill patients, patients in shock, dehydrated patients, or hyperosmolar patients.
This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.
This system has not been tested at altitudes higher than 10,150 feet.
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Meters and lancing devices should never be used by more than one person. Do not share them with anyone, including other family members, due to the risk of infection from bloodborne pathogens. Do not use on multiple patients!
Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.
## D Special Instrument Requirements:
- Accu-Chek Guide Solo diabetes manager
- Accu-Chek Solo Micropump System
## IV Device/System Characteristics:
### A Device Description:
The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system consists of the Accu-Chek Guide Solo diabetes manager blood glucose meter, Accu-Chek Guide Test Strips and Accu-Chek Guide Control Solutions (Level 1 and Level 2, cleared in k160944). It is used for self-monitoring of blood glucose. The Accu-Chek Guide Test Strips and Accu-Chek Guide Control Solutions are purchased separately. The device is powered by a rechargeable battery and serves as a remote control and primary user interface for the Accu-Chek Solo micropump system (k213134).
All meter kits include a Carrying Case, User's Manual, Quick Reference Guide, Warranty Card and Logbook. Materials needed but not provided include a single user lancing device and sterile lancets.
### B Principle of Operation:
The meter measures glucose amperometrically using an FAD-GDH enzyme located on the test strip, which converts the glucose in the blood to gluconolactone. The meter converts the measured current into blood glucose reading that is displayed on the meter's display. The sample and the environmental conditions are evaluated using AC and DC signals. The meter converts the measured current into blood glucose reading that is displayed on the meter's display.
### C Instrument Description Information:
1. Instrument Name:
Accu-Chek Guide Solo diabetes manager
2. Specimen Identification:
There is no sample identification function with this device. Samples are applied directly to the test strip as they are collected.
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3. Specimen Sampling and Handling:
Capillary whole blood samples drawn from the fingertips. Samples are to be tested immediately upon collection.
4. Calibration:
The meter does not require calibration by the user, it is factory calibrated.
5. Quality Control:
Two levels of glucose control solutions are available for use with this system and can be purchased separately (Accu-Chek Guide Control Solutions, Level 1 and Level 2, cleared in k160944). Recommendations on when to test with control solutions are provided in the labeling. Acceptable ranges for each level of control solution are printed on the test strip vial label. The user is cautioned not to use the meter if the control result falls outside these ranges. The control solution readings are automatically marked by the meter as control results and are not included in the patient result averages.
V Substantial Equivalence Information:
A Predicate Device Name(s):
Accu-Chek Guide Blood Glucose Monitoring System
Accu-Chek Connect Diabetes Management App
B Predicate 510(k) Number(s):
K160944
K150910
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K213131 | K160944 |
| --- | --- | --- |
| Device Trade Name | Accu-Chek Guide Solo diabetes manager glucose monitoring system | Accu-Chek Guide Blood Glucose Monitoring System |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Quantitative measurement of glucose in fresh capillary whole blood samples. | Same |
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| Control Solutions | 2 Levels, aqueous solutions, shelf life of 24 months | Same |
| --- | --- | --- |
| Strip Chemical Composition | Glucose Dehydrogenase (GDH/FAD) | Same |
| General Device Characteristic Differences | | |
| Alternate Site Testing | No AST claim | Palm, Forearm, and Upper Arm |
| Batteries | Rechargeable lithium polymer battery | 2 CR2032 |
| Display | Capacitive color LCD multi-touch screen | Dot Matrix LCD |
| Device & Predicate Device(s): | K213131 | K150910 |
| --- | --- | --- |
| Device Trade Name | Accu-Chek Guide Solo diabetes manager glucose monitoring system | Accu-Chek Connect Diabetes Management App |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Calculation of insulin dose or carbohydrate intake based on user-entered data. | Same |
| General Device Characteristic Differences | | |
| Connected Devices | Accu-Chek Solo micropump system | Accu-Chek Aviva Connect Blood Glucose Meter |
VI Standards/Guidance Documents Referenced:
FDA Guidance Document: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use. Guidance for Industry and Food and Drug Administration Staff. Issued on September 29, 2020.
ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices
IEC 62304-1 Edition 1.1 2015-06 consolidated version-Medical device software- Software life cycle processes
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CLSI EP06-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 MOD)
IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
AIM Standard 7351731 Rev. 2.00 2017-02-23 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers
ANSI IEEEC63.27-2017 American National Standard for Evaluation of Wireless Coexistence
AAMI TIR69:2017/(R2020) Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.
## VII Performance Characteristics (if/when applicable):
## A Analytical Performance:
1. Precision/Reproducibility:
Within-run Precision (Repeatability):
A within-run precision study using 3 lots of Accu-Chek Guide Test Strips was performed. Venous blood was spiked to 8 concentrations (i.e. 20, 40, 80, 130, 200, 325, 450, and 550 mg/dL). For each sample concentration, 10 meters were used, with 10 measurements taken by each meter, and 3 lots tested (i.e. 100 measurements per concentration per lot). Glucose reference results were determined using a comparator method.
Results for the within-run precision study are summarized below:
| Strip Lot | Target Glucose (mg/dL) | N | Mean Glucose (mg/dL) | SD (mg/dL) | CV (%) |
| --- | --- | --- | --- | --- | --- |
| 1 | 20 | 100 | 13.6 | 1.1 | 8.4 |
| 2 | 20 | 100 | 14.1 | 0.9 | 6.7 |
| 3 | 20 | 100 | 14.0 | 1.1 | 8.2 |
| Lots combined | 20 | 300 | 13.9 | 1.1 | 7.9 |
| 1 | 40 | 100 | 38.2 | 1.3 | 3.3 |
| 2 | 40 | 100 | 37.8 | 1.3 | 3.3 |
| 3 | 40 | 100 | 38.5 | 1.2 | 3.2 |
| Lots combined | 40 | 300 | 38.2 | 1.3 | 3.4 |
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# Intermediate precision (Between Run):
Intermediate (between run) precision was evaluated using 3 lots of the Accu-Chek test strips performed on 6 levels of control solutions (i.e. Level 1:10-29 mg/dL, Level 2: 30-50 mg/dL, Level 3: 111-150 mg/dL, Level 4: 251-400 mg/dL, Levels 5 and 6: 501-600 mg/dL). The tests were conducted with 10 meters, 1 measurement per meter per day at the 5 different glucose ranges, for 10 days. Results for the intermediate precision study are summarized below:
| Strip Lot | Control Level | N | Mean Glucose (mg/dL) | SD (mg/dL) | CV (%) |
| --- | --- | --- | --- | --- | --- |
| 1 | 1 | 100 | 28.9 | 1.2 | 4.2 |
| 2 | 1 | 100 | 27.6 | 1.1 | 4.1 |
| 3 | 1 | 100 | 28.2 | 1.0 | 3.6 |
| Lots combined | 1 | 300 | 28.3 | 1.2 | 4.4 |
| 1 | 2 | 100 | 46.5 | 1.2 | 2.6 |
| 2 | 2 | 100 | 45.2 | 1.2 | 2.6 |
| 3 | 2 | 100 | 45.8 | 1.6 | 3.4 |
| Lots combined | 2 | 300 | 45.8 | 1.4 | 3.1 |
| 1 | 3 | 100 | 120.7 | 2.0 | 1.6 |
| 2 | 3 | 100 | 117.5 | 2.6 | 2.2 |
| 3 | 3 | 100 | 119.3 | 2.4 | 2.0 |
| Lots combined | 3 | 300 | 119.2 | 2.6 | 2.2 |
| 1 | 4 | 100 | 309.6 | 5.7 | 1.8 |
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| 2 | 4 | 100 | 306.6 | 6.3 | 2.1 |
| --- | --- | --- | --- | --- | --- |
| 3 | 4 | 100 | 307.3 | 6.9 | 2.2 |
| Lots combined | 4 | 300 | 307.8 | 6.4 | 2.1 |
| 1 | 5 | 100 | 519.0 | 10.5 | 2.0 |
| 2 | 5 | 100 | 513.9 | 7.3 | 1.4 |
| 3 | 5 | 100 | 521.5 | 8.0 | 1.5 |
| Lots combined | 5 | 300 | 518.1 | 9.3 | 1.8 |
| 1 | 6 | 100 | 571.3 | 7.9 | 1.4 |
| 2 | 6 | 100 | 561.9 | 9.1 | 1.6 |
| 3 | 6 | 100 | 569.8 | 9.5 | 1.7 |
| Lots combined | 6 | 300 | 567.7 | 9.7 | 1.7 |
# 2. Linearity:
Linearity was evaluated using three reagent lots and 36 Accu-Chek Guide Solo diabetes manager blood glucose meters by testing venous blood samples spiked with glucose at concentrations ranging from 5.2 to 603.2 (5.2, 14, 38.8, 60.8, 89.7, 123.4, 155.7, 198.8, 289, 449.4, 603.2) mg/dL, as measured by the comparator method. One run (across all 36 meters) was performed with each sample using each of the strip lots. The values from the meter were compared with those obtained from the comparator method. The results from regression analysis are summarized below:
| Test Strip Lot | Slope | Y-Intercept | R2 |
| --- | --- | --- | --- |
| 1 | 0.97 | 0.0969 | 0.9983 |
| 2 | 0.95 | 0.51 | 0.9976 |
| 3 | 0.96 | 1.55 | 0.9983 |
| All Lots Pooled | 0.96 | 0.7189 | 0.9981 |
The results of the study support the sponsor's claimed glucose measurement range of 20 to 600 mg/dL. The meter will display "LO" when the result is less than 20 mg/dL and "HI" when result is greater than 600 mg/dL. The sponsor validated the "LO" and "HI" functions and demonstrated that they functioned as intended.
# 3. Analytical Specificity/Interference:
To assess potential interference the sponsor used a venous whole blood sample adjusted to 3 different glucose levels, split into a control sample and a test sample. Various endogenous and exogenous substances were then added to the test sample only. The $\%$ difference between the test and control sample was calculated and the concentration tested at which no significant interference was observed is presented in the table below:
| Potential Interfering Substance | Highest Concentration with no Significant Interference |
| --- | --- |
| Acetaminophen | 20 mg/dL |
| Ascorbic acid | 6 mg/dL |
| Bilirubin (conjugated and unconjugated) | 60 mg/dL |
| Cholesterol | 500 mg/dL |
| Creatinine | 30 mg/dL |
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| Dopamine | 0.09 mg/dL |
| --- | --- |
| Galactose | 300 mg/dL |
| Gentisic Acid | 1.8 mg/dL |
| Glutathione (reduced, L-Glutathione) | 6.14 mg/dL |
| Hemoglobin | 1000 mg/dL |
| Heparin | 8000 U/dL |
| Ibuprofen | 50 mg/dL |
| Lactitol | 100 mg/dL |
| EDTA | 360 mg/dL |
| Xylitol | 200 mg/dL |
| L-Dopa | 2 mg/dL |
| Maltitol | 20.2 mg/dL |
| Maltose | 685 mg/dL |
| Mannitol | 1800 mg/dL |
| Methyl Dopa | 2.25 mg/dL |
| Pyridinealdoxime Methiodide (PAM) | 25 mg/dL |
| Salicylic Acid | 60 mg/dL |
| Sorbitol | 70 mg/dL |
| Tolazamide | 200 mg/dL |
| Tolbutamide | 100 mg/dL |
| Triglycerides | 1800 mg/dL |
| Uric Acid | 23.5 mg/dL |
| Xylose | 10 mg/dL |
| Sodium | 165 mmol/L |
| Isomalt | 0.09 mg/dL |
The sponsor has the following limitations in their labeling:
- 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.
4. Assay Reportable Range:
20-600 mg/dL glucose
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Traceability: The Accu-Chek Guide Solo diabetes Manager is traceable to the NIST SRM 917c glucose reference material.
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Test Strip Stability: The protocols and acceptance criteria for the Accu-Chek Guide Blood Glucose test strips previously cleared in K160944 and found to be acceptable. The sponsor claims that both closed-vial (shelf life) and open-vial stability are up to 18 months when stored at the recommended storage temperatures of 39-86°F (4-30°C) and 10-90% RH. The labeling instructs the users not to freeze the test strips.
6. Detection Limit:
Please see the linearity section above (VII.A.2).
7. Assay Cut-Off:
Not applicable.
8. Accuracy (Instrument):
Not applicable.
9. Carry-Over:
Not applicable.
B Comparison Studies:
1. Method Comparison with Predicate Device:
See Lay-user study below (VII.C.3).
2. Matrix Comparison:
Not applicable.
C Clinical Studies:
1. Clinical Sensitivity:
Not applicable.
2. Clinical Specificity:
Not applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Method Comparison/Lay User Performance study:
To assess system accuracy, results from the Accu-Chek Guide Solo Blood Glucose Monitoring System were compared to a reference method, PCA-HK. Capillary samples from 350 participants with glucose concentrations ranging from 48 to 478 mg/dL glucose obtained
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on the reference were measured using one of three test strip lots by a technician. Samples were tested using 3 meters and 3 test strip lots. Results are summarized in the tables below:
| Glucose concentrations <75 mg/dL | | |
| --- | --- | --- |
| Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL |
| 6/6 (100 %) | 6/6 (100 %) | 6/6 (100 %) |
| Glucose concentrations ≥ 75 mg/dL | | | |
| --- | --- | --- | --- |
| Within ± 5 % | Within ± 10 % | Within ± 15 % | Within ± 20 % |
| 227/344 (66.0%) | 318/344 (92.4%) | 337/344 (98.0%) | 342/344 (99.4%) |
| Glucose Concentrations for entire measuring range | | | |
| --- | --- | --- | --- |
| Within ± 5 % | Within ± 10 % | Within ± 15 % | Within ± 20 % |
| 233/350 (66.6 %) | 324/350 (92.6 %) | 343/350 (98.0 %) | 348/350 (99.4 %) |
Linear regression results for all strip lots tested (N=350):
$$
Y = 0.998x - 1.1; r^2 = 0.982
$$
Accuracy at Extreme Glucose Study:
A study to evaluate the performance of Accu-Chek Guide Solo Blood Glucose Monitoring System in the extreme lower and upper ends of the claimed range was performed using 59 altered samples with glucose concentrations below 80 mg/dL, and 61 altered samples greater than 250 mg/dL. Samples were altered by spiking or glycolysis in order to obtain the appropriate glucose concentrations. Samples were tested on Accu-Chek Guide Test Strips from 3 lots. The glucose concentrations in the samples ranged from 25.7-80.2 mg/dL on the lower end and 257.5-600.1 mg/dL on the higher end, obtained using PCA-HK. Results are summarized below:
Extreme glucose accuracy for glucose concentrations <80 mg/dL:
| Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| --- | --- | --- | --- |
| 34/59 (57.6 %) | 56/59 (94.9 %) | 59/59 (100.0%) | 59/59 (100.0%) |
Extreme glucose accuracy for glucose concentrations >250 mg/dL:
| Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| --- | --- | --- | --- |
| 48/61 (78.7%) | 61/61 (100.0%) | 61/61 (100.0%) | 61/61 (100.0%) |
Usability:
At the end of the study, each participant was asked to complete a usability questionnaire regarding ease of understanding of information in the user manual and the ease of use when performing a blood glucose test. From the sponsor's analysis of the questionnaire responses, the participants overall were satisfied with the ease of operation by following the instructions for use in the User's Manual and the overall performance of the Accu-Chek Guide Solo diabetes manager blood glucose monitoring system.
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Readability:
A Flesch-Kincaid readability assessment was conducted, and the results demonstrated that the Accu-Chek Guide Solo diabetes manager blood glucose monitoring system instructions for use are written for a reading level equivalent to or lower than 8th grade.
## D Clinical Cut-Off:
Not applicable.
## E Expected Values/Reference Range:
Based on published literature, the sponsor included the following in the labeling:
The ideal ranges for adults without diabetes are:
- less than 100 mg/dL before meals.
- less than 140 mg/dL within 2 hours after a meal.
References:
American Diabetes Association website; Diagnosing Diabetes and Learning about Prediabetes. http://www.diabetes.org/diabetes-basics/diagnosis/. Accessed April 22, 2019.
American Diabetes Association. 2. Classification and diagnosis of diabetes; Diabetes Care Standards of Medical Care in Diabetes- 2019. 2019; 42 (Suppl. 1): S13-S28.
Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Report of the expert committee on the diagnosis and classification of diabetes mellitus. Diabetes Care. 2003 Jan;26 Suppl 1:S5-20. doi: 10.2337/diacare.26.2007.s5. PMID: 12502614.
## F Other Supportive Instrument Performance Characteristics Data:
### 1) Hematocrit Study:
The protocols and acceptance criteria for the Accu-Chek Guide Solo Diabetes Manager blood glucose monitoring system are being leveraged from the previously cleared in K160944 and found to be acceptable. Briefly, different hematocrit levels was evaluated using whole blood samples with hematocrit levels of 10 – 65% (10, 15, 20, 25, 30, 35, 45, 50, 55, 60, 65 %) spiked with glucose to achieve target concentrations between 30-50, 51- 110, 111-144, 150-250, 251- 400 mg/dL. A total of 10 replicates per run, per strip lot, per hematocrit level, and per glucose level were tested on 30 Accu-Chek Guide meters. The results demonstrated that the Accu-Chek Guide produces accurate results over the claimed hematocrit range of 10 – 65%.
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2) Altitude Study:
The protocols and acceptance criteria for the Accu-Chek Guide Solo Diabetes Manager blood glucose monitoring system are being leveraged from the previously cleared in K160944 and found to be acceptable. Briefly, capillary fingerstick blood samples from 102 donors using three lots of Accu-Chek guide glucose test strips were tested at 10,150 feet above sea level using Accu-Chek Guide glucose meters. The meter results support the claims in the labeling that altitudes up to 10,150 feet have no significant effect on blood glucose measurement.
3) Flex Studies:
The following additional flex studies were performed with the Accu-Chek Guide Solo Diabetes Manager blood glucose monitoring system: system operating conditions testing, short sample detection, sample perturbation, intermittent sampling, and used test strips, drop, and shipping testing. The testing demonstrated that the device is robust under these conditions.
4) Infection Control Studies:
The device is intended for single patient use. Six Accu-Chek Guide Solo Diabetes Manager meters were subjected to 208 cleaning cycles, representing one cleaning per week for four years. Three meters were used for control/reference purposes that were not subjected to cleaning. The study demonstrated that cleaning the meter did not impact device durability or function. Disinfection efficacy studies were performed on the materials compromising the meter with the chosen disinfectant, Super Sani-Cloth (EPA registration #9480-4), demonstrating complete inactivation of hepatitis B virus (HBV). Robustness studies were also performed by the demonstrating that there was no change in performance or external materials of the meter after 208 cleaning and disinfection cycles (representing weekly disinfection for four years, the expected lifetime of the meter).
5) Test strip lot release criteria:
The test strip lot release protocols and criteria were reviewed and found to be acceptable.
6) Electromagnetic Compatibility (EMC) testing:
The sponsor provided documentation certifying that acceptable electrical safety and EMC testing had been performed and the system was found to be compliant.
VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
