ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
Device Facts
| Record ID | K130284 |
|---|---|
| Device Name | ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM |
| Applicant | ACON Laboratories, Inc. |
| Product Code | NBW · Clinical Chemistry |
| Decision Date | Dec 20, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The On Call Sharp Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative site testing should be done only during steady-state times (when blood glucose level is not changing rapidly). The On Call Sharp Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only. The On Call Sharp Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates. The On Call Sharp Blood Glucose Test Strips are used with the On Call Sharp Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm. The On Call Sharp Blood Glucose Control Solutions are for use with the On Call Sharp Blood Glucose Meter and On Call Sharp Blood Glucose Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.
Device Story
System measures capillary whole blood glucose via amperometric electrochemical enzymatic assay (GDH-FAD). User applies blood sample to test strip; meter calculates glucose concentration from electrical current; displays result. Used at home by patients for diabetes management. Includes meter, test strips, control solutions, lancing device, lancets. Provides quantitative glucose readings to aid in monitoring diabetes control programs. Single-patient use only; requires coding via test strip label.
Clinical Evidence
Clinical study with 103 lay users performing fingerstick, palm, and forearm testing. Accuracy compared to YSI reference analyzer. Results showed 100% of fingertip samples within ±20% of YSI for glucose ≥75 mg/dL and 100% within ±15 mg/dL for glucose <75 mg/dL. Bench testing included precision (CV 3.2-4.5%), linearity (20-600 mg/dL), interference studies, hematocrit (25-70%), altitude, and temperature/humidity testing.
Technological Characteristics
Amperometric glucose monitoring system using GDH-FAD enzyme biosensor. Measuring range 20-600 mg/dL. Power: two CR2032 3.0V batteries. Connectivity: non-wireless data transfer. Operating conditions: 10-45°C, 10-90% RH. Hematocrit range: 25-70%.
Indications for Use
Indicated for people with diabetes for quantitative measurement of glucose in fresh capillary whole blood (fingertip, palm, forearm) to monitor diabetes control programs. Not for neonates, screening/diagnosis of diabetes, critically ill, shock, dehydrated, or hyper-osmolar 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
- On Call® Vivid Blood Glucose Monitoring System (K112653)
Related Devices
- K180196 — On Call Express Mobile Blood Glucose Monitoring System · ACON Laboratories, Inc. · Mar 7, 2018
- K132086 — ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM · ACON Laboratories, Inc. · Dec 19, 2013
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number:
k130284
B. Purpose for Submission:
New device
C. Measurand:
Capillary whole blood glucose
D. Type of Test:
Quantitative amperometric (FAD- Glucose Dehydrogenase)
E. Applicant:
Acon Laboratories Inc.
F. Proprietary and Established Names:
On Call Sharp Blood Glucose Monitoring System
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NBW | Class II | 21 CFR§ 862.1345, Glucose Test System | Clinical Chemistry (75) |
| LFR | Class II | 21 CFR§ 862.1345, Glucose Test System | Clinical Chemistry (75) |
| JJX | Class I, reserved | 21 CFR § 862.1660, Quality control material | Clinical Chemistry (75) |
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H. Intended Use:
1. Intended use(s):
See Indications for Use below.
2. Indication(s) for use:
The On Call Sharp Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative site testing should be done only during steady-state times (when blood glucose level is not changing rapidly). The On Call Sharp Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only.
The On Call Sharp Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates.
The On Call Sharp Blood Glucose Test Strips are used with the On Call Sharp Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.
The On Call Sharp Blood Glucose Control Solutions are for use with the On Call Sharp Blood Glucose Meter and On Call Sharp Blood Glucose Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.
3. Special conditions for use statement(s):
For In Vitro Diagnostic use
For Over-the-Counter use
Not for neonatal use
Not for screening or diagnosis of diabetes mellitus
Not for use on critically ill patients, patients in shock, dehydrated patients or hyper-osmolar patients
AST should not be used to calibrate continuous glucose monitors (CGMs) nor for use in insulin dose calculations.
AST testing should only be done during steady-state times (when glucose is not changing rapidly).
Single-patient use only system; should not be shared
4. Special instrument requirements:
On Call Sharp Blood Glucose Meter
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I. Device Description:
The On Call Sharp Blood Glucose Monitoring System consists of the On Call Sharp Blood Glucose Meter, On Call Sharp Blood Glucose Test Strips and On Call Sharp Blood Glucose Control Solutions, a lancing device and sterile lancets. The blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.
The On Call Sharp Blood Glucose Control Solutions are used to confirm that the meter and strips are working properly. The solutions contain known concentrations of glucose, and preservatives in an aqueous based mixture bottled into dropper bottles with caps. Three solution levels are available (Levels 0, 1, and 2). Level 1 is provided with the system. Levels 0 and 2 are sold separately.
J. Substantial Equivalence Information:
1. Predicate device name(s):
On Call Vivid Blood Glucose Monitoring System
2. Predicate 510(k) number(s):
k112653
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | On Call Sharp Blood Glucose Monitoring System (Candidate Device) | On Call Vivid BGMS (Predicate Device, k112653) |
| Indication For Use | The On Call Sharp Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood as an aid in monitoring the effectiveness of diabetes control programs. | Same |
| Assay Method | Electrochemical | Same |
| Detection method | Amperometry | Same |
| Measuring | 20 – 600 mg/dL | Same |
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| Range | | |
| --- | --- | --- |
| Test Time | 5 seconds | Same |
| Memory capacity | up to 500 with time and date | Same |
| Power source | Two CR2032 3.0 V coin cell batteries | Same |
| Operating humidity | 10 - 90 % | Same |
| Sample | Fresh capillary whole blood | Same |
| Weight | Approx. 60g ( including batteries) | Same |
| Differences | | |
| --- | --- | --- |
| Item | On Call Sharp Blood Glucose Monitoring System (Candidate Device) | On Call Vivid BGMS (Predicate Device, k112653) |
| Test Strip Enzyme | FDA- dependent Glucose Dehydrogenase Biosensor | Glucose Oxidase biosensor |
| Battery Life | IGM-0028A: Running 5,000 Tests IGM-0028B(Back Light LCD): Running 1,000 Tests | Running 5,000 Tests N/A |
| Operating temperature | 10 - 45 °C (50 - 113 °F) | 5 - 45 °C (41 - 113 °F) |
| Hematocrit range (%) | 25-70% | 20-70% |
| Items | On Call Sharp Blood Glucose Control Solution (Candidate Device) | On Call Vivid Blood Glucose Control Solution (Predicate Device, k112653) |
| --- | --- | --- |
| IFU | To confirm that your Test Strips and Blood Glucose Meter are working together properly and that you are performing the test correctly. | Same |
| Number of Controls | Three levels of control solution are available. They are Control Solution 0, 1, and Control Solution 2. | Two levels of control solution are available. They are Control Solution 1 and Control Solution 2. |
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| Composition | 1) Control Solution 0 contains less than 0.1% glucose (active ingredient).
2) Control Solution 1 contains less than 0.2% glucose (active ingredient).
3) Control Solution 2 contains less than 0.4% glucose (active ingredient).
All have preservatives in an aqueous based mixture. | 1) Control solution 1 contains less than 0.2% glucose (active ingredient).
2) Control Solution 2 contains less than 0.4% glucose (active ingredient).
Both have preservatives in an aqueous based mixture. |
| --- | --- | --- |
K. Standard/Guidance Document Referenced (if applicable):
ISO 15197:2003 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
ISO 13640:2002 Stability and testing of in vitro diagnostic reagents
ISO 14791:2009 Medical Devices – Application of risk management to medical devices.
ISO GP14-A:1996 Labeling of Home-Use In Vitro Testing Products; Approved Guideline.
CLSI Guideline, EP6-A: Evaluation of the Linearity of Quantitative measurement procedures: A statistical approach; Approved Guideline.
CLSI Guideline, EP7-A2 Interference Testing in Clinical Chemistry; Approved Guideline. Second Edition
EN 61326-1:2006 Class B Electrical equipment for measurement, control and laboratory use – EMC requirements
EN 61326-2-6:2006 Electrical equipment for measurement, control and laboratory use. Particular requirements. In vitro diagnostic (IVD) medical equipment
EN 62366:2008 Medical devices. Application of usability engineering to medical devices
EN 62304: 2006 Medical device software. Software life-cycle process
EN 10993-5:2009 Biological evaluation of medical devices. Test for irritation and delayed-type hypersensitivity
EN 10993-5:2009 Biological evaluation of medical devices. Test for in vitro cytotoxicity
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EN11607-1-2006 Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems
EN11137-2:2000 Sterilization of medical devices. Microbiological Methods. Test of sterility performed in the validation if a sterilization process
EN11137:2006 Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices.
EN11137-2:2007 Sterilization of health care products. Radiation. Establishing the sterilization dose.
EN11137-3:2006 Sterilization of health care products. Radiation. Guidance on docimetric aspects.
EN11137-1:2006 Sterilization of medical devices. Microbiological Methods. Determination of a population of microorganisms on products
EN556-1 2001/AC:2006 Sterilization of health care products. Radiation. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices.
IEC 61010-1: 2001 Safety requirements for electrical equipment for measurement, control and laboratory use – Part 1: General Requirements.
IEC 61010-2-101: 2002 Safety requirements for electrical equipment for measurement, control and laboratory use. Particular requirements for In Vitro Diagnostic (IVD) Medical Equipment.
## L. Test Principle:
The On Call Sharp Blood Glucose Monitoring System is an amperometric method that uses flavin adenine dinucleotide-glucose dehydrogenase (GDH-FAD) enzyme chemistry and a mediator that reacts with glucose in the whole blood sample to produce an electrical current. This current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed, calibrated to plasma reference.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Within run precision was performed using five venous blood samples spiked with glucose to achieve higher glucose concentrations and allowed to equilibrate for at least 2 hours before use). The samples tested ranged from 39 to 328 mg/dL. Each sample was tested 10 times on three test strip lots, using 10 meters per test strip lot for
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n = 100 per test strip lot. The mean values, standard deviations and coefficients of variation were calculated for each sample and are summarized below.
| Within-day precision (whole blood) | | | | | |
| --- | --- | --- | --- | --- | --- |
| Lot # | Glucose Concentration (mg/dL) | n | Mean (mg/dL) | SD (mg/dL) | CV (%) |
| 1 | 43 | 100 | 42 | 1.68 | 4.0 |
| | 79 | 100 | 78 | 3.09 | 4.0 |
| | 125 | 100 | 127 | 4.48 | 3.5 |
| | 199 | 100 | 199 | 7.45 | 3.7 |
| | 319 | 100 | 320 | 12.74 | 4.0 |
| 2 | 40 | 100 | 40 | 1.56 | 3.9 |
| | 78 | 100 | 76 | 2.96 | 3.9 |
| | 124 | 100 | 124 | 4.58 | 3.7 |
| | 199 | 100 | 199 | 7.22 | 3.6 |
| | 328 | 100 | 328 | 12.49 | 3.8 |
| 3 | 39 | 100 | 39 | 1.69 | 4.3 |
| | 76 | 100 | 75 | 3.00 | 4.0 |
| | 129 | 100 | 131 | 4.94 | 3.8 |
| | 197 | 100 | 197 | 8.78 | 4.5 |
| | 322 | 100 | 324 | 11.55 | 3.6 |
The intermediate precision evaluation was performed using three levels of control solutions. A total of 300 strips each from three lots of test strips were used with a minimum of 10 meters, 10 replicates per day, for 10 days. The glucose concentration of each sample was determined using the YSI Glucose Analyzer. The mean values and coefficients of variation were calculated for each sample and are summarized below.
| Day-to-day precision (control materials) | | | | |
| --- | --- | --- | --- | --- |
| Lot # | N | Mean (mg/dL) | SD (mg/dL) | CV (%) |
| 1 | 100 | 44 | 1.76 | 4.0 |
| | 100 | 121 | 4.93 | 4.1 |
| | 100 | 358 | 11.39 | 3.2 |
| 2 | 100 | 43 | 1.59 | 3.7 |
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| | 100 | 122 | 4.91 | 4.0 |
| --- | --- | --- | --- | --- |
| | 100 | 349 | 12.82 | 3.7 |
| 3 | 100 | 46 | 1.71 | 3.7 |
| | 100 | 122 | 5.19 | 4.2 |
| | 100 | 336 | 12.33 | 3.7 |
b. Linearity/assay reportable range:
A linearity study was performed using eleven different levels (10, 25, 50, 80, 110, 170, 220, 330, 450, 550, and 650 mg/dL) of venous whole blood samples supplemented with a glucose stock solution to cover the claimed measuring range from 20 to 600 mg/dL. Four measurements were taken from each glucose level and measured using 3 lots of test strips on a minimum of 2 meters. Linear regression analysis resulted in the equation $y = 1.0409x - 5.2697$ with an $R^2 = 0.9903$. The claimed measuring range is 20 to 600 mg/dL based on the linearity data.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability
The glucose control standards are traceable to a NIST SRM 917bᵃ glucose standard and are prepared at three target concentrations (Level 0 = 51 mg/dL, Level 1 = 125 mg/dL and Level 2 = 330 mg/dL). The reference instrument used is the YSI 2300 Glucose analyzer.
Stability
Accelerated stability study was conducted to assess the shelf-life stability of the control solutions and test strips. Real-time stability studies are still on-going. Stability studies protocols and acceptance criteria were provided and found to be adequate.
Unopened control solutions have a 24 month shelf life and are stable for 1 month after first use when stored at 5 - 30°C (35.6 - 86°F).
Unopened test strips have a 24 month shelf-life and are stable for 1 month after first use when stored at 5 - 30°C (35.6 - 86°F) at a %RH of 10-90%.
Expected values
The controls are prepared at three target concentrations gravimetrically. The solution is then compared to the NIST standard and then the glucose concentrations are verified with the YSI reference method. The expected values are verified for each new lot of strips.
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d. Detection limit:
See linearity study above in section 1.b.
e. Analytical specificity:
The interference study was designed according to CLSI EP7-A2 guideline. 35 common endogenous and exogenous interfering substances were evaluated by spiking venous blood to three levels of glucose concentrations (50, 100, 350 mg/dL). The glucose samples were then spiked with the potentially interfering compounds (2 concentration including normal or therapeutic levels and high or toxic levels). Two meters were used for this study with 4 strips for each meter. Three lots of test strips were tested for a total of 1152 test strips. Bias was calculated as the mean percent difference in glucose reading between the test and control concentration groups. The sponsor claims no significant interference if bias between the tested and the control sample is $< 10\%$ difference. A summary of the concentrations of the potential interfering substances tested is summarized in the table below:
| Interfering Substances | Maximum Concentration tested at which no interference is observed (mg/dL) |
| --- | --- |
| Acetaminophen | 20 |
| Ascorbic Acid | 3 |
| Cholesterol | 500 |
| Conjugated-Bilirubin | 50 |
| Creatinine | 5 |
| Dopamine | 0.09 |
| Ephedrine | 0.5 |
| Ethanol | 400 |
| Fructose | 100 |
| Galactose | 30 |
| Gentistic acid | 10 |
| Glutathione | 1 |
| Hemoglobin | 500 |
| Ibuprofen | 50 |
| Lactose | 25 |
| L-Dopa (Levo-Dopa) | 3 |
| Maltose | 200 |
| Mannitol | 600 |
| Methyl Dopa | 1.5 |
| Salicylic Acid | 60 |
| Sorbitol | 70 |
| Tetracycline | 1.5 |
| Tolazamide | 10 |
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| Tolbutamide | 64 |
| --- | --- |
| Triglycerides | 3000 |
| Unconjugated-Bilirubin | 40 |
| Uric Acid | 23.5 |
| Urea | 600 |
| Xylose | 4 |
Based on the study data, all the substances and levels tested above have <10% bias except for ascorbic acid > 3 mg/dL (above therapeutic levels) and xylose > 4 mg/dL. Ascorbic acid levels > 3 mg/dL and xylose > 4 mg/dL will interfere with the glucose reading; therefore, the sponsor has the following limitation in their labeling:
"Ascorbic acid (vitamin C) (when occurring in blood at normal or at high therapeutic concentration) do not significantly affect results. However, abnormally high concentration (> 3 mg/dL) in blood may cause inaccurately high results."
"Do not use during or soon after xylose absorption testing. Xylose (> 4mg/dL) in the blood will cause interference"
Sodium Fluoride interferes with blood glucose testing in the On Call Sharp Blood Glucose Monitoring System. The sponsor has included the following warning "Never test blood that has been placed in test tubes containing fluoride or other anticoagulants. This will cause falsely low results."
f. Assay cut-off:
Not applicable.
2. Comparison studies:
a. Method comparison with predicate device:
The accuracy of the ACON On Call Sharp Blood Glucose Monitoring System was assessed by comparing whole blood glucose results to the YSI. Samples were obtained from 103 different subjects over 29 days. 5 of the 103 subjects' fingertip samples were also aged to obtain glucose concentrations <50 mg/dL and 5 of the 103 subjects' fingertip samples were also supplemented with additional glucose to obtain glucose concentrations >400 mg/dL. A total of 3 test strip lots and 36 meters were used. The glucose concentration range of the samples tested was 34 to 592 mg/dL. The data is summarized below:
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# Fingertip Sample:
System Accuracy Results for Glucose concentration $< 75\mathrm{mg / dL}$
| Strip Lot | Within ± 5mg/dL | Within ± 10 mg/dL | Within ±15 mg/dL |
| --- | --- | --- | --- |
| 1 | 9/14 (64.3%) | 14/14 (100%) | 14/14 (100%) |
| 2 | 10/14 (71.4%) | 14/14 (100%) | 14/14 (100%) |
| 3 | 12/14 (85.7%) | 14/14 (100%) | 14/14 (100%) |
| Combined | 31/42 (73.8%) | 42/42 (100.00%) | 42/42 (100%) |
System Accuracy Results for Glucose concentration $\geq 75\mathrm{mg / dL}$
| Strip Lot | Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| --- | --- | --- | --- | --- |
| 1 | 56/99 (56%) | 86/99 (86.9%) | 99/99 (100%) | 99/99 (100%) |
| 2 | 55/99 (55.6%) | 83/99 (83.8%) | 98/99 (100%) | 99/99 (100%) |
| 3 | 61/99 (61.6%) | 91/99 (91.9%) | 98/99 (100%) | 99/99 (100%) |
| Combined | 172/297 (57.9%) | 260/297 (87.5%) | 295/297 (99.3%) | 297/297 (100%) |
# Palm Sample:
System Accuracy Results for Glucose concentration $< 75\mathrm{mg / dL}$
| Strip Lot | Within ± 5mg/dL | Within ± 10 mg/dL | Within ±15 mg/dL |
| --- | --- | --- | --- |
| 1 | 4/9 (44.4%) | 8/9 (88.9%) | 9/9 (100%) |
| 2 | 5/9 (55.6%) | 9/9 (100%) | 9/9 (100%) |
| 3 | 4/9 (44.4%) | 9/9 (100%) | 9/9 (100%) |
| Combined | 13/27 (48.1%) | 26/27 (96.3%) | 27/27 (100%) |
System Accuracy Results for Glucose concentration $\geq 75\mathrm{mg / dL}$
| Strip Lot | Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| --- | --- | --- | --- | --- |
| 1 | 34/94 (32.2%) | 74/94 (78.7%) | 94/94 (100%) | 94/94 (100%) |
| 2 | 43/94 (45.7%) | 75/94 (79.8%) | 93/94 (98.9%) | 94/94 (100%) |
| 3 | 47/94 (50.0%) | 79/94 (84.0%) | 93/94 (98.9%) | 94/94 (100%) |
| Combined | 124/282 (44.0%) | 228/282 (80.9%) | 280/282 (99.3%) | 282/282 (100%) |
# Forearm Sample:
System Accuracy Results for Glucose concentration $< 75\mathrm{mg / dL}$
| Strip Lot | Within ± 5mg/dL | Within ± 10 mg/dL | Within ±15 mg/dL |
| --- | --- | --- | --- |
| 1 | 7/9 (77.8%) | 8/9 (88.9%) | 9/9 (100%) |
| 2 | 6/9 (66.7%) | 9/9 (100%) | 9/9 (100%) |
| 3 | 8/9 (88.9%) | 9/9 (100%) | 9/9 (100%) |
| Combined | 21/27 (77.8%) | 27/27 (100%) | 27/27 (100%) |
System Accuracy Results for Glucose concentration $\geq 75\mathrm{mg / dL}$
| Strip Lot | Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| --- | --- | --- | --- | --- |
| 1 | 50/94 (53.2%) | 82/94 (87.2%) | 93/94 (98.9%) | 94/94 (100%) |
| 2 | 39/94 (41.5%) | 79/94 (84.0%) | 94/94 (100%) | 94/94 (100%) |
| 3 | 45/94 (47.9%) | 80/94 (85.1%) | 93/94 (98.9%) | 94/94 (100%) |
| Combined | 134/282 (47.5%) | 241/282 (85.5%) | 280/282 (99.3%) | 282/282 (100%) |
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Regression between ACON On Call Sharp Blood Glucose Monitoring System results and the YSI for the capillary blood samples:
| Sample Site | Strip Lot | Slope | Intercept | R² | N |
| --- | --- | --- | --- | --- | --- |
| Fingertip | 1 | 1.0265 | -4.6214 | 0.9890 | 113 |
| Fingertip | 2 | 1.0443 | -6.7028 | 0.9894 | 113 |
| Fingertip | 3 | 1.0324 | -2.5683 | 0.9933 | 113 |
| Fingertip | Combined | 1.0344 | -4.6308 | 0.9904 | |
| Palm | 1 | 1.0052 | -5.7371 | 0.9784 | 103 |
| Palm | 2 | 0.9930 | -4.2799 | 0.9795 | 103 |
| Palm | 3 | 0.9953 | -3.2084 | 0.9821 | 103 |
| Palm | Combined | 0.9978 | -4.4084 | 0.9799 | |
| Forearm | 1 | 1.0613 | -8.1484 | 0.9832 | 103 |
| Forearm | 2 | 1.0563 | -7.8509 | 0.9817 | 103 |
| Forearm | 3 | 1.0441 | -5.4430 | 0.9813 | 103 |
| Forearm | Combined | 1.0539 | -7.1475 | 0.982 | |
b. Matrix comparison:
Not applicable. Capillary whole blood is the only indicated matrix.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.
b. Clinical specificity:
Not applicable.
c. Other clinical supportive data (when a. and b. are not applicable):
Lay user studies
One hundred and three (103) lay users participated in the study. Three (3) strip lots were tested on 36 meters. Instructions for use were given to each study subject to let the subject learn and understand how to run testing for the studied system. After reading the instructions, each study subject performed fingerstick testing on the studied system by themselves. A trained technician also ran the same testing with the same subject's fingerstick blood. The same procedure for fingerstick testing was then repeated for palm and forearm alternative sites. Both layperson and technician
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performed the testing for each subject sample for the user study. For each study subject, additional fingerstick capillary blood was also collected into microtainer tubes (w/ heparin anticoagulant) for the YSI reference instrument testing and hematocrit level testing. The tested glucose concentration range was from 58 to 392 mg/dL. A questionnaire was given to each study subject for their feedback on the ACON On Call Sharp Blood Glucose Monitoring System.
| Linear Regression Summary Table: Meter Reading (y) vs. Plasma YSI Value (x) | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Tested By | Sample Site | Strip Lot | Slope | Intercept | R | R² | N |
| Layperson | Fingertip | 1 | 1.0407 | -6.4065 | 0.9918 | 0.9836 | 103 |
| Layperson | Fingertip | 2 | 1.0208 | -4.1204 | 0.9851 | 0.9705 | 103 |
| Layperson | Fingertip | 3 | 1.0623 | -6.3760 | 0.9894 | 0.9789 | 103 |
| Layperson | Palm | 1 | 0.9868 | -2.8861 | 0.9899 | 0.9798 | 103 |
| Layperson | Palm | 2 | 1.0142 | -5.9534 | 0.9894 | 0.9788 | 103 |
| Layperson | Palm | 3 | 0.9957 | -1.6720 | 0.9889 | 0.9780 | 103 |
| Layperson | Forearm | 1 | 1.0820 | -10.1895 | 0.9901 | 0.9803 | 103 |
| Layperson | Forearm | 2 | 1.0611 | -6.8329 | 0.9906 | 0.9812 | 103 |
| Layperson | Forearm | 3 | 1.0648 | -5.4734 | 0.9907 | 0.9815 | 103 |
Combined data from 3 lots for Fingerstick (Layperson vs YSI)
| Linear Regression | y = 1.0413 x -5.6343 | | |
| --- | --- | --- | --- |
| R² | 0.9770 | | |
| <75 mg/dL | Within ± 5mg/dL | Within ± 10 mg/dL | Within ± 15mg/dL |
| | 20/27 (74.1%) | 26/27 (96.3%) | 27/27 (100.0%) |
| ≥75 mg/dL | Within ±5% | Within ±10% | Within ±15% |
| | 135/282 (47.9%) | 229/282 (81.2%) | 279/282 (98.9%) |
Combined data from 3 lots for
| Linear Regression | y = 0.9989 x -3.5038 |
| --- | --- |
| R2 | 0.9786 |
Patient Palm vs YSI 2300
| System accuracy results for glucose concentration <75 mg/dL | | | |
| --- | --- | --- | --- |
| Within ± 5mg/dL | Within ± 10 mg/dL | Within ± 15mg/dL | |
| 12/27 (44.4%) | 27/27 (100%) | 27/27 (100%) | |
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| System accuracy results for glucose concentration ≥75 mg/dL | | | |
| --- | --- | --- | --- |
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| 133/282 (47.2%) | 224/282 (79.49%) | 278/282 (98.6%) | 282/282 (100%) |
| Combined data from 3 lots for Linear Regression | y = 1.0693 x -7.4986 |
| --- | --- |
| R2 | 0.9808 |
Patient Forearm vs YSI
| System accuracy results for glucose concentration <75 mg/dL | | | |
| --- | --- | --- | --- |
| Within ± 5mg/dL | Within ± 10 mg/dL | Within ± 15mg/dL | |
| 20/27 (74.1%) | 24/27 (88.9%) | 27/27 (100%) | |
| System accuracy results for glucose concentration ≥75 mg/dL | | | |
| --- | --- | --- | --- |
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| 132/282 (46.8%) | 220/282 (78.0%) | 277/282 (98.2%) | 282/282 (100%) |
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
Expected blood glucose values for people without diabetes are as below:
| Time | Range, mg/dL | Range, mmol/L |
| --- | --- | --- |
| Fasting and Before Meals | 70-100 | 3.9-5.6 |
| 2 Hours after Meals | Less than 140 | Less than 7.8 |
ADA Clinical Practice Recommendations, 2013. Diabetes Care, 2013, Vol.36, Supplement 1, S67-S74.
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N. Instrument Name:
ACON On Call Sharp Blood Glucose Meter
O. System Descriptions:
1. Modes of Operation:
Each test strip is single use and must be replaced with a new strip for additional readings.
Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?
Yes ☐ X or No
Does the applicant’s device transmit to a computer, webserver, or mobile device using wireless transmission?
Yes ☐ or No ☐ X
2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ X or No
3. Specimen Identification:
There is no sample identification function with this device. Samples are applied directly to the test strip as they are collected.
4. Specimen Sampling and Handling:
This device is intended to be used with capillary whole blood from the fingertip, palm or forearm which is directly applied to the test strip.
5. Calibration:
The device must be coded with the code found on the current test strip label. No further calibration is required.
6. Quality Control:
There are three levels of glucose control solution (Level 0, 1 and 2) that can be run with this device. Level 1 is included with the test kit and Levels 0 and 2 can be purchased separately. Recommendations on when to test the control materials are provided in the
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labeling. An acceptable range for each control level is printed on the test strip vial label. The user is cautioned not to use the meter if the control result falls outside these ranges.
P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
1. Hematocrit Study: The effect of different hematocrit levels on the performance of the ACON On Call Sharp BGMS was evaluated using venous whole blood samples with hematocrit levels of 20, 25, 30, 40, 50, 60, 65 and 70% and spiked with glucose to achieve 5 concentrations ranging from 50 to 525 mg/dL (50, 100, 275 and 525 mg/dL). Each sample was then tested 4 times on three different test strip lots and the values were compared with those obtained from YSI reference analyzer. The % biases relative to YSI were acceptable within the claimed hematocrit range of 25 to 70%.
2. Altitude study: Fingerstick capillary blood samples from fifteen subjects were tested on 6 test strips (3 strip lots) on 6 On Call Sharp meters. The sample range tested was 33 to 491 mg/dl for sea level and at 8, 516 ft. Blood glucose target concentrations were then verified by the reference YSI glucose analyzer. The results demonstrate acceptable bias to YSI to support the claims in the labeling that altitudes up to 8, 516 feet have no significant effect on blood glucose measurements from the On Call Sharp Blood Glucose Monitoring System.
3. Sample volume study: The sponsor performed a study to verify the minimum test strip sample volume requirement and the test strip fill error requirement established for the On Call Sharp Blood Glucose Monitoring System. Blood samples were tested at six sample volumes (0.4, 0.6, 0.7, 0.8 and 1.0μL) and values obtained were compared to YSI values. Results support the claimed minimum sample volume of 0.8 μL and the error code for insufficient sample volume.
4. Temperature and humidity studies: The sponsor performed temperature and humidity studies using venous blood samples in vacutainer tubes with heparin anticoagulant to evaluate temperatures of 10, 21 and 45°C and relative humidity of 10% to 90%. Meter results were compared to YSI reference analyzer. Six temperature and humidity combinations were tested including low temperature/low humidity, low temperature/high humidity, average temperature/low humidity, average temperature/high humidity, high temperature/low humidity and high temperature/high humidity. No significant effect (relative to YSI reference analyzer) was observed with the temperature and humidity combinations tested. The results support the claims in the labeling that the system can be used in conditions of 10 to 45°C with relative humidity of 10 to 90%.
5. Infection Control Studies: The On Call Sharp Blood Glucose Monitoring System is intended for single-patient use. DisCide Ultra Disinfecting Towelettes with EPA registration number 10492-4 were validated demonstrating complete inactivation of live virus for use with the meter. The sponsor also demonstrated that there was no change in performance or in the external materials of the meter after 3,285 cleaning and disinfection cycles (one cycle includes one cleaning wipe plus one disinfecting wipe) to simulate 5 years of meter use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.
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6. EMC testing was evaluated and certified by TUV Rheinland (Shanghai) Co., LTD and Verification of Compliance reports are provided.
7. Flesch-Kincaid readability assessment was conducted and the results demonstrated that the User Manual, test strip package insert, control solution package insert and Quick Reference Guide Insert were written at the 7.4 grade level, 7.5 grade level, 7.0 grade level and 7.2 grade level respectively.
Customer service is available 24 hours a day, 7 days a week by calling 1-800-838-9502,
Q. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
R. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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