(261 days)
No
The summary describes a standard blood glucose monitoring system and associated software for data management. There is no mention of AI, ML, or any advanced analytical techniques beyond basic data review and analysis. The performance studies focus on standard analytical and clinical accuracy metrics for glucose measurement.
No.
A therapeutic device is used to treat a disease or condition. This device is a diagnostic tool used to measure blood glucose levels, aiding in monitoring the effectiveness of diabetes control, not directly treating the condition itself.
Yes
Explanation: The device is explicitly described as an "in vitro diagnostic use" system by the manufacturer, designed to quantitatively measure glucose for monitoring diabetes control. While it is not intended for the initial diagnosis or screening of diabetes, it fits the definition of a diagnostic device as it aids in assessing a health condition.
No
The device description clearly states that the system consists of a glucose test meter, test strips, control solution, lancing device, and software. This includes significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The CERA-CHEK 1070 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use)..."
- Nature of the Test: The system measures glucose in blood samples outside the body, which is the definition of an in vitro diagnostic test.
- Components: The system includes components specifically designed for in vitro testing, such as test strips and control solutions.
N/A
Intended Use / Indications for Use
The CERA-CHEK 1070 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf. The CERA-CHEK 1070 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The CERA-CHEK 1070 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes controls. The CERA-CHEK 1070 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The CERA-CHEK 1070 Blood Glucose Test Strips are for use with the CERA-CHEK 1070 Blood Glucose Test Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf.
The CERA-CHEK 1070 Control Solution is for use with the CERA-CHEK 1070 Blood Glucose Test Meter and Test strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.
The CERA-CHEK Diabetes Management Software is PC-based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose results for effective diabetes management. It is intended for use as an accessory to compatible CERAGEM MEDISYS blood glucose monitoring systems. The CERA-CHEK Diabetes Management Software's language is English.
Product codes
LFR, NBW, JJX, JQP
Device Description
The CERA-CHEK 1070 Blood Glucose Monitoring System consists of the CERA-CHEK 1070 Glucose Test Meter, CERA-CHEK 1070 Blood Glucose Test Strips with Code Key, CERA-CHEK 1070 Control Solution 1 and Control Solution 2, a Lancing device, and CERA-CHEK Diabetes Management Software and cable needed for installing the software on the PC and for transmitting data from meter. Control Solution 1 and Control Solution 2 are required but not included with the meter. Control Solution 1 and Control Solution 2 are always provided as a set. CERA-CHEK Diabetes Management Software and cable are required but not included with the meter. CERA-CHEK Diabetes Management Software and cable are always provided as a set.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Fingertip, forearm, upper arm, palm, thigh, or calf.
Indicated Patient Age Range
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Intended User / Care Setting
self testing outside the body (in vitro diagnostic use) by people with diabetes at home; home and professional settings
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1. Analytical performance
- Precision/Reproducibility
- Within-run Precision: Evaluated by analyzing venous whole blood samples spiked to five different glucose concentrations (30-50, 51-110, 111-150, 151-250, 251-400 mg/dL). Hematocrit of samples was between 35 and 50%. Five different lot numbers of test strips and ten meters were used. Each sample measured ten times per strip lot number per meter, total 100 measurements per glucose concentration.
- Day to day precision: Evaluated by analyzing control samples at three different concentrations (30-50, 96-144, 280-420 mg/dL). Three lot numbers of test strips (one per glucose level) and ten meters were used. Each control level measured once per day over twenty days. Each control level measured once per strip lot number per meter. Total 600 measurements for each of the three levels.
- Linearity/assay reportable range: Evaluated by preparing 9 glucose samples, with target values of 11, 52, 89, 157, 234, 310, 386, 461, 531, and 607 mg/dL. Each of the ten levels analyzed five times using three lots of test strips. All samples also tested on the YSI 2300 analyzer.
- Traceability, Stability, Expected values:
- Traceability: Traceable to YSI 2300 Glucose analyzer, calibrated using NIST traceable YSI 2747 Glucose Standard.
- Shelf-life stability (closed vial): Test strip shelf-life of 24 months supported when stored at 1-32°C and 10-85% RH. Control shelf-life of 12 months supported when stored at 1-32°C and below 50% RH.
- In-use stability (open vial): Test strip open vial stability of four months supported when stored at 1-32°C and 10-85% RH. Control open vial stability of four months supported when stored at 1-32°C and below 50% RH.
- Detection Limit: Measuring range of 20 - 600 mg/dL, validated by linearity study.
- Analytical specificity: Interference studies performed with substances like Acetaminophen, Ascorbic acid, Dopamine, Ibuprofen, Metformin, Methyldopa, Salicylic acid, Uric acid, Bilirubin, Triglyceride, Cholesterol, Creatinine, Galactose, Gentisic acid, Glutathione, Hemoglobin, L-dopa, Maltose, Sodium, Tolbutamide, Tolazamide, Xylose, Mannitol, Sorbitol, Xylitol, Lactitol, Isomalt, Maltitol, Hydrogenated starch hydrolysates. Highest levels of Dopamine, Methyldopa, and Tolazamide may cause inaccurate results. Xylose (>10mg/dL) causes interference.
2. Comparison studies
- Method comparison with predicate device / System Accuracy Study:
- User performance study: 200 participants collected and tested twice their own fingerstick sample in single measurements on the CERA-CHEK 1070 BGMS.
- Healthcare professional tested collected samples of 200 participants and 20 contrived samples on CERA-CHEK 1070 BGMS.
- Within five minutes, fingerstick sample collected from each participant by a healthcare professional for the system accuracy study and tested on the YSI 2300 reference analyzer.
- Sample size for System Accuracy Study: 200 participants' samples + 20 contrived samples.
- Key results, Glucose concentration = 75mg/dL:
- Technician: 58% within +/-5%, 82% within +/-10%, 96% within +/-15%, 100% within +/-20%.
- User: 56% within +/-5%, 76% within +/-10%, 94% within +/-15%, 100% within +/-20%.
- Linear regression:
- Technician vs YSI: Slope 1.0365, Intercept -5.5769, Correlation coefficient 0.9948.
- User vs YSI: Slope 1.0322, Intercept -3.0441, Correlation coefficient 0.9901.
- Alternate Site Test: 100 volunteer samples. Samples from alternative sites (Palm, Forearm, Upper arm, Thigh, Calf capillary blood) measured by volunteers (lay user) and professionals (Professional) using the meter and also on a YSI 2300 reference analyzer.
- Key results, Glucose concentration = 75mg/dL:
- Palm: Professional 73% within +/-5%, Lay user 62% within +/-5%. All 100% within +/-20% for both.
- Forearm: Professional 59% within +/-5%, Lay user 62% within +/-5%. All 100% within +/-20% for both.
- Upper arm: Professional 65% within +/-5%, Lay user 64% within +/-5%. All 100% within +/-20% for both.
- Thigh: Professional 66% within +/-5%, Lay user 65% within +/-5%. All 100% within +/-20% for both.
- Calf: Professional 64% within +/-5%, Lay user 57% within +/-5%. All 100% within +/-20% for both.
- Linear regression and correlation coefficient for Alternate Site Test:
- Professional vs YSI: Slopes between 1.0230 and 1.0519; Intercepts between -0.0445 and 2.1615; Correlation coefficients between 0.9945 and 0.9967.
- Lay user vs YSI: Slopes between 1.0254 and 1.0504; Intercepts between -1.5331 and 2.1956; Correlation coefficients between 0.9933 and 0.9965.
- Key results, Glucose concentration = 75mg/dL:
3. Other Supportive Instrument Performance Characteristics Data
- Hematocrit study: Evaluated using venous whole blood samples with hematocrit levels across the claimed range and altered to glucose concentrations from 21 - 529 mg/dL. Five measurements for each combination. Demonstrated accurate results over 10-70% hematocrit range.
- Altitude study: Evaluated at glucose concentrations of approximately 100, 200, and 300 mg/dL using a decompression chamber. Three lots of test strips and three meters used. Samples tested by YSI 2300 analyzer. Demonstrated accurate results at altitudes up to 13,200 feet.
- Temperature and humidity studies: Three test strip lots tested on three glucose concentrations (approx. 45, 120, 300 mg/dL) at twelve combinations of temperature and humidity. Replicates of three. Temperatures 10.0°C to 41.2°C, relative humidity 10.3%-86.6%. Demonstrated non-significant effect on glucose results at 10–40°C (50–104°F) and 10-85% RH.
- Infection Control Studies: Disinfection efficacy studies performed on meter and lancing device materials with CaviWipes, demonstrating complete inactivation of HBV. Robustness studies simulating 5 years of single-patient use (1825 cleanings and 1825 disinfection steps) showed no change in performance or external materials.
- Usability Study: Untrained lay users assessed readability of labeling. Users completed questionnaire on clarity of instructions and ease of use. Majority understood instructions and successfully operated device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
K 131727
FEB 2 8 2014
CERAGEM Medisys Inc. www.ceragemmedisys.com
510(k) Summary
In accordance with the requirements of 21 CFR.807.92, the following information about 510(k) safety and effectiveness is being submitted.
-
- Submitter
CERAGEM Medisys Inc.
- Submitter
16 Jeongji1-gil. Seonggeo-eup. Seobuk-gu, Cheonan-si. Chungcheongnam-do. 331-833. Korea Phone : (+82) 41-529-8422 Fax : (+82) 41-551-0767
-
- Date Prepared
February 28, 2014
- Date Prepared
-
- Device Name
Common name : CERA-CHEK 1070 Blood Glucose Monitoring System
- Device Name
Classification : Class II
(Regulation: 21 CFR § 862.1345)
Product Code : LFR, NBW(Blood Glucose Test System, Over the Counter), JJX, JQP
Predicate Device 4.
CERA-CHEK 1070 Blood Glucose Monitoring System is substantially equivalent to Ascensia® CONTOUR ® Blood Glucose Monitoring System described as below.
- (1) Device Name: Ascensia® CONTOUR ® Blood Glucose Monitoring System
- (2) Manufacturer: Bayer HealthCarc, LLC.
- (3) 510(K) Number: K062058
ર. Device Description
The CERA-CHEK 1070 Blood Glucose Monitoring System consists of the CERA-CHEK 1070 Glucose Test Meter, CERA-CHEK 1070 Blood Glucose Test Strips with Code Key, CERA-CHEK 1070 Control Solution 1 and Control Solution 2, a Lancing device, and CERA-CHEK Diabetes Management Software and cable needed for installing the software on the PC and for transmitting data from meter. Control Solution 1 and Control Solution 2 are required but not included with the meter. Control Solution 1 and Control Solution 2 are always
1
provided as a set. CERA-CHEK Diabetes Management Software and cable are required but not included with the meter. CERA-CHEK Diabetes Management Software and cable are always provided as a set.
6. Intended Use
CERAGEM
..
MEDISYS
The CERA-CHEK 1070 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf. The CERA-CHEK 1070 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The CERA-CHEK 1070 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes controls. The CERA-CHEK 1070 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The CERA-CHEK 1070 Blood Glucose Test Strips are for use with the CERA-CHEK 1070 Blood Glucose Test Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf.
The CERA-CHEK 1070 Control Solution is for use with the CERA-CHIEK 1070 Blood Glucose Test Meter and Test strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.
The CERA-CHEK Diabetes Management Software is PC-based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose results for effective diabetes management. It is intended for use as an accessory to compatible CERAGEM MEDISYS blood glucose monitoring systems. The CERA-CHEK Diabetes Management Software's language is English.
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- Comparison to Predicate Device
2
Image /page/2/Picture/0 description: The image shows the logo for CERAGEM MEDISYS. The word "CERAGEM" is in large, bold, sans-serif font on the top line. Below that, in a smaller font, is the word "MEDISYS". To the right of the words is a stylized geometric shape.
CERAGEM Medisys Inc. www.ceragemmedisys.com
| Comparison | ||
|---|---|---|
| Item | Device | Predicate |
| Device Name | CERA-CHEK 1070 | Ascensia® CONTOUR® |
| Similarities | ||
| Detection Method | Amperometry | Amperometry |
| Enzyme | Glucose dehydrogenase | |
| (FAD-GDH) | Glucose dehydrogenase | |
| (FAD-GDH) | ||
| Test Time | 5 seconds | 5 seconds |
| Differences | ||
| Coding | No coding | No coding |
| Memory | 1000 blood glucose test results | |
| with date and time | 480 blood glucose test results | |
| with date and time | ||
| Test range | 20-600 mg/dL | 10-600 mg/dL |
| Sample Volume | 0.5 uL | 0.6 uL |
| Humidity range | 10-85% | 10-93% |
| Temperature range | 50-104°F | |
| 10-40°C | 41~113°F | |
| 5-45°C | ||
| Power(Battery) | One 3-volt lithium battery | |
| (CR2032) | Two 3-volt lithium batteries | |
| (DL2032 or CR2032) | ||
| Level of QC | 2 Levels (Control 1, Control 2) | 3 Levels (Low, Normal, High) |
| Dimensions | 94mm(H) x 53.6(W) x 14.9mm(T) | 77mm(H) x 57mm(W) x 19mm(T) |
| Weight | 40g | 47.5g |
| Hematocrit range | 10-70% | 20-60% |
Conclusion
As the comparison table, the CERA-CHEK 1070 Blood Glucose Monitoring System have same detection method, test range, and test time. Furthermore, the CERA-CHEK 1070 Blood Glucose Monitoring System is also using same enzyme and mediator. To sum up with the similarities, the CERA-CHEK 1070 Blood Glucose Monitoring System is similar with the predicate device because most of the specifications deciding the characteristic of the device are same. In conclusion, despite of the difference such as memory, coding, and etc, the CERA-CHEK 1070 Blood Glucose Monitoring System is substantially equivalent as compared to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for CERAGEM MEDISYS. The text "CERAGEM" is in bold, uppercase letters on the top line. Below that, the text "MEDISYS" is in smaller, uppercase letters. To the right of the text is a stylized graphic of a cube with a smaller cube inside.
◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆
-
- Performance Characteristics
1. Analytical performance
A. Precision/Reproducibility
(1) Within-run Precision
Within-run precision was evaluated by analyzing venous whole blood samples spiked to five different glucose concentrations. The hematocrit of all samples was between 35 and 50%. Five different lot numbers of test strips and ten meters were used in the study and each of the samples was measured ten times per strip lot number per meter for a total of 100 measurements per glucose concentration. The samples were analyzed by one operator in one day.
| Interval | 1 | 2 | 3 | 4 | 5 |
|---|---|---|---|---|---|
| Glucose concentration | 30~50 | 51~110 | 111~150 | 151~250 | 251~400 |
| YSI (mg/dL) | 44 | 96 | 127 | 226 | 323 |
| Mean | 45.2 | 97.6 | 129.1 | 228.3 | 326.1 |
| STD(mg/dL) | 2.4 | 3.1 | 4.1 | 6.9 | 7.3 |
| CV (%) | 5.2 | 3.1 | 3.2 | 3.0 | 2.2 |
(2) Day to day precision
Day to day precision was evaluated by analyzing control samples at three different concentrations. Three lot numbers of test strips (one per glucose level) and ten meters were used in the study. Each of the controllevels was measured once per day over twenty. Each of the control levels was measured once per strip lot number per meter. In total, 600 measurements were taken for each of the three levels. Results are summarized below:
| Interval | 1 | 2 | 3 |
|---|---|---|---|
| Glucose concentration | 30~50 | 96~144 | 280~420 |
| YSI, mg/dL | 43 | 108 | 304 |
| Mean | 42.6 | 108.4 | 303.8 |
| STD(mg/dL) | 2.3 | 3.4 | 8.6 |
| CV(%) | 5.5 | 3.2 | 2.8 |
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B. Linearity/assay reportable range
CERACE
.
MEDISYS
The sponsor evaluated the linearity of the meter by preparing a series of 9 glucose samples, following the dilution scheme in CLSI EP6-A, and producing target values of 11, 52, 89, 157, 234, 310, 386, 461, 531, and 607 mg/dL.
·Each of the ten levels was analyzed five times using three lots of test strips. All samples were also tested on the YSI 2300 analyzer. Linear regression of the data produced the following:
| Strip Lot | Slope | Intercept | Corr Coeff ( $r^2$ ) |
|---|---|---|---|
| 1 | 0.9896 | 1.4433 | 0.9995 |
| 2 | 0.9786 | 2.4223 | 0.9997 |
| 3 | 0.9782 | 4.4741 | 0.9992 |
The results of the study support the sponsor's claimed glucose measurement range of 20 - 600 mg/dL.
C. Traceability, Stability, Expected values (controls, calibrators, or methods)
The CERA-CHEK 1070 Blood Glucose Monitoring System is traccable to the YSI 2300 Glucose analyzer which is calibrated using the YSI 2747 Glucose Standard which is a NIST traceable glucose standard.••
Test strip shelf-life stability (closed vial) was assessed in an accelerated study with real time studies ongoing, The protocols and acceptance criteria were reviewed and found to be acceptable. The testing supported the claimed shelf life of 24 months when stored at 1- 32° C and 10-85% RH.
Test strip in-use stability (open vial) was assessed in real time studies. The protocols and acceptance criteria were reviewed and found to be acceptable. The testing supported the open vial stability of four months when stored at 1- 32° C and 10-85% RH.
Control shelf-life stability (closed vial) was assessed an accelerated study with real time studies ongoing. The protocols and acceptance criteria were reviewed and found to be acceptable. The testing supported the claimed shelf life of 12 months when stored at 1- 32° C and below 50% RH.
Control in-use stability (open vial) was assessed in real-time studies. The protocols and acceptance criteria were reviewed and found to be acceptable. The testing supported the open vial stability of four months when
5
stored at 1- 32° C and below 50% RH.••
D. Detection Limit
CERAGEM
MEDISYS
The measuring range of the device is 20 - 600 mg/dL. This range was validated by the linearity study.
E. Analytical specificity
The sponsor performed interference studies in accordance with CLSI EP7-A. Testing was performed in parallel (control samples vs. test samples) to minimize the effects of glucose metabolism. Whole blood was drawn into K3-EDTA anticoagulant tubes from healthy volunteers who were not on any medications. The glucose levels tested were 64, 151, and 257 mg/dL. The highest level was achieved by spiking. A low and high concentration of each potential interferent was then tested at each glucose level. The following substances were found not to interfere at the concentrations listed:
| Substance | No interference up to: |
|---|---|
| Acetaminophen | 6 mg/dL |
| Ascorbic acid | 4 mg/dL |
| Dopamine | 5 mg/dL |
| Ibuprofen | 40 mg/dL |
| Metformin | 4 mg/dL |
| Methyldopa | 5 mg/dL |
| Salicylic acid | 50 mg/dL |
| Uric acid | 10 mg/dL |
| Bilirubin | 4 mg/dL |
| Triglyceride | 1,500 mg/dL |
| Cholesterol | 500 mg/dL |
| Creatinine | 10 mg/dL |
| Galactose | 100 mg/dL |
| Gentisic acid | 2 mg/dL |
| Glutathione | 3 mg/dL |
| Hemoglobin | 20 g/dL |
| L-dopa | 4 mg/dL |
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| Maltose | 100 mg/dL |
|---|---|
| Sodium | 150 mmol/L |
| Tolbutamide | 64 mg/dL |
| Tolazamide | 5 mg/dL |
| Xylose | 10 mg/dL |
| Mannitol | 800 mg/dL |
| Sorbitol | 100 mg/dL |
| Xylitol | 100 mg/dL |
| Lactitol | 100 mg/dL |
| Isomalt | 100 mg/dL |
| Maltitol | 100 mg/dL |
| Hydrogenated starch | |
| hydrolysates | 100 mg/dL |
The sponsor has the following limitations in their labeling
- � High concentrations of dopamine, methyldopa, and Tolazamidc may cause inaccurate test results
- . Do not use during or soon after xylose absorption testing. Xylose (>10mg/dL) in the blood will cause interference.
2. Comparison studies
A. Method comparison with predicate device
For the user performance study, 200 participants collected and tested twice their own fingerstick sample in single measurements on the CERA-CHEK 1070 BGMS. The healthcare professional tested the collected samples of 200 participants and 20 contrived samples on CERA-CHEK 1070 BGMS. Within five minutes, fingerstick sample was collected from each participant by a healthcare professional for the system accuracy study and was tested on the YSI 2300 reference analyzer.
System Accuracy Study
Difference distribution for glucose concentration 600 mg/dL and therefore not included in data analysis.
Linear regression
CERAGEM
••
MEDISYS
| Slope | Intercept | Correlation coefficient | |
|---|---|---|---|
| (95% Confidence Interval) | |||
| Technician vs YSI | 1.0365 | -5.5769 | 0.9948 |
| (1.0223~1.0507) | (-8.2708~-2.8831) | ||
| User vs YSI | 1.0322 | -3.0441 | 0.9901 |
| (1.0117~1.0527) | (-6.4963~0.1081) |
B. Alternate Site Test
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Image /page/8/Picture/1 description: The image contains text describing a study performed with a total of 100 volunteer samples. Samples from an alternative site were measured by volunteers and professionals using a meter. The samples were also measured using a reference analyzer.
Difference distribution for glucose concentration