(85 days)
YSI Model 2300 STAT PLUS (K913806)
No
The summary describes a standard blood glucose monitoring system using amperometric detection and basic calculations. There is no mention of AI, ML, or any advanced algorithms for data analysis or interpretation beyond displaying the calculated glucose concentration. The data transfer function is for viewing and analyzing stored data, not for AI/ML processing.
No.
The device is intended for quantitative measurement of glucose to aid in monitoring diabetes control, not for treating or preventing the disease.
No
Explanation:
The "Intended Use / Indications for Use" section explicitly states: "The On Call Express Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates." While it measures glucose levels, it is intended to "aid to monitoring the effectiveness of diabetes control programs" rather than diagnose the condition.
No
The device description clearly states that the system contains a blood glucose meter and test strips, which are hardware components. While it includes software for data transfer and management, the core functionality relies on physical hardware for glucose measurement.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of glucose in fresh capillary whole blood". This involves testing a biological sample (blood) in vitro (outside the body) to obtain diagnostic information (glucose levels).
- Device Description: The description details the components and how the system works to measure glucose in a blood sample using a chemical reaction on a test strip and an electrical measurement by the meter. This is a classic description of an in vitro diagnostic process.
- Control Solutions: The inclusion and description of control solutions for verifying the accuracy of blood glucose test results further confirms its nature as an IVD, as quality control is a standard practice for IVD devices.
- Clinical Tests Performed: The performance studies involve testing blood samples and comparing results to a reference method (YSI analyzer), which is typical for validating the accuracy and performance of an IVD.
- Predicate Device: The predicate device listed (On Call Express Blood Glucose Monitoring System) is also a blood glucose monitoring system, which are generally classified as IVDs.
The device is designed to analyze a biological sample (blood) outside the body to provide information about a physiological state (glucose levels) as an aid to monitoring diabetes control. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The On Call Express Pro 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. The On Call Express Pro Blood Glucose Monitoring System is intended for multiple patient use by health care professionals in health care facilities as an aid to monitoring the effectiveness of diabetes control programs. The system should only be used with single-use, auto disabling lancing devices.
The On Call Express Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates. Alternative site testing (AST) testing should only be done during steady-state times (when glucose is not changing rapidly).
The On Call Express Pro Blood Glucose Test Strips are used with the On Call Express Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm. The On Call Express Pro Blood Glucose Control Solution is for use with the On Call® Express Pro Blood Glucose Meter and Strips as a quality control check to verify the accuracy of blood glucose test results.
Product codes
NBW, CGA, JJX
Device Description
The On Call Express Pro Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm and forearm. The glucose measurement is achieved by using the amperometric detection method.
The test strip has a reagent system including glucose oxidase and a mediator that reacts with glucose in the whole blood sample to produce an electrical current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.
The On Call Express Pro Blood Glucose Monitoring System contains a blood glucose meter and On Call Express Pro blood glucose test strips. This is a no code meter. The On Call Express Pro Blood Glucose Monitoring System consists of the On Call Express Pro Blood Glucose Meter, On Call Express Pro Blood Glucose control solutions (Level 1 and Level 2), Carrying Case, User's Manual, Warranty Card and Logbook. Materials needed but not provided are the On Call Express Pro Blood Glucose Test strips and disposable, single use lancing devices.
Control solution(s) is/are viscosity-adjusted, buffered aqueous control solutions that contain known concentrations of d-glucose. The products are intended for use to verify the performance of the On Call Express Pro Blood Glucose Monitoring System
On Call Express Pro Blood Glucose Monitoring System has a data transfer function.
Data Port sends information to a computer via an optional data transfer cable. It allows users to view, analyze and print stored data in the meter. The data transfer cable is available for order as an optional add-on. The meter can transfer stored test results to a Windows-based personal computer (PC) using an optional data transfer cable and the On Call® Diabetes Management Software (K131469). The software has been validated for use with On Call Express meter (K132086) which is the exact same device as On Call Express Pro meter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertips, forearm and palm
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
Health care professionals in health care facilities.
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
Method comparison with predicate device:
- Sample size: 103 natural capillary blood samples (fingertips, forearms) and 8 altered samples (glycolyzed or spiked).
- Data source: Natural capillary blood samples collected from fingertips, forearms, and palm, as well as altered samples. Reference values obtained from YSI Model 2300 STAT PLUS.
- Annotation protocol: Not explicitly stated as annotation protocol, but performance was assessed by comparing results from the On Call Express Pro Blood Glucose Monitoring System to the YSI Model 2300 STAT PLUS.
User Performance Study:
- Sample size: 103 study subjects.
- Data source: Capillary blood samples collected from participants for YSI measurement. Self-test results from fingerstick, forearm, and palm using the On Call Express Pro Blood Glucose Monitoring System.
- Annotation protocol: Not explicitly stated as annotation protocol, but performance was assessed by comparing the lay user self-test results to the YSI method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory Performance Testing:
- Study type: Repeatability precision, intermediate precision, linearity, interfering agents, hematocrit effect, temperature effect evaluation - blood & control solution, low battery effect, altitude effect, sample volume, humidity effect, simulated shipping study - test strip & control solution, control value assignment, meter testing, software validation testing, electromagnetic compatibility and electrical safety testing.
- Sample size:
- Within-run (Repeatability): Venous blood samples at five glucose levels, tested on three lots of test strips on 10 meters (10 strips per meter). 10 replicates per meter, test strip lot, and glucose concentration (300 measurements per glucose level).
- Intermediate Precision: Three lots of test strips, ten meters. Glucose control solutions in three concentration ranges. Each control solution measured once per day on 10 meters in replicates of 10, with three test strip lots for 10 days, generating 100 individual measurements (300 measurements per glucose level).
- Linearity: 3 lots of test strips, 2 meters, and 11 venous whole blood samples with glucose levels ranging from 20-600 mg/dL. Each glucose level tested with 4 test strips over 3 test strip lots.
- Analytical specificity (Interference): Venous whole blood samples adjusted to three glucose concentration intervals (50-60 mg/dL, 100-120 mg/dL, and 300-350 mg/dL). Each potential interfering substance tested at a minimum of two concentrations.
- Key results:
- Repeatability: %CV ranged from 1.9 to 3.5 across different glucose levels and strip lots.
- Intermediate Precision: %CV ranged from 2.2 to 3.9 across different control levels and strip lots.
- Linearity: R2 values of 0.9991, 0.9993, and 0.9992 for the three test strip lots. Measurement range is 20 - 600 mg/dL.
- Traceability: Traceable to NIST SRM 917b.
- Stability: Unopened control solutions have a 24-month shelf life, stable for 6 months after first opening. Test strips stable for 6 months after first opening.
- Analytical specificity: Comprehensive table of substances and concentrations with no significant interference (≤ ±10 % difference).
Clinical Tests Performed:
- Study type: Method comparison with predicate device (professional user) and User Performance Study (lay persons).
- Sample size:
- Method comparison: 103 natural capillary blood samples collected from fingertips, forearms, and 8 altered samples.
- User Performance Study: 103 study subjects.
- Key results:
- Method comparison (Professional user):
- **Fingertip (Glucose
- Method comparison (Professional user):
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid with three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
September 5, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ACON LABORATORIES, INC. QIYI XIE SR. STAFF REGULATORY AFFAIRS/CLINICAL AFFAIRS 10125 MESA RIM ROAD SAN DIEGO CA 92121
Re: K151595
Trade/Device Name: On Call® Express Pro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. CGA. JJX Dated: June 12, 2015 Received: June 15, 2015
Dear Oiyi Xie:
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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2-Qiyi Xie
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151595
Device Name
On Call® Express Pro Blood Glucose Monitoring System
Indications for Use (Describe)
The On Call Express Pro 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. The On Call Express Pro Blood Glucose Monitoring System is intended for multiple patient use by health care professionals in health care facilities as an aid to monitoring the effectiveness of diabetes control programs. The system should only be used with single-use, auto disabling lancing devices.
The On Call Express Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates. Alternative site testing (AST) testing should only be done during steady-state times (when glucose is not changing rapidly).
The On Call Express Pro Blood Glucose Test Strips are used with the On Call Express Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm. The On Call Express Pro Blood Glucose Control Solution is for use with the On Call® Express Pro Blood Glucose Meter and Strips as a quality control check to verify the accuracy of blood glucose test results.
| 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) |
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7. 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The Assigned 510(k) number is K151595
Submitter's Identification:
ACON Laboratories, Inc.
10125 Mesa Rim Road
San Diego, California 92121
Tel.: 858-875-8019 Fax: 858-875-8011
Date Prepared: August 18, 2015
Contact Person:
Qiyi Xie Senior Staff, Clinical & Regulatory Affairs Email: qxie@aconlabs.com
Proprietary Name of the Device:
On Call Express Pro Blood Glucose Monitoring System
Common Name:
Glucose Test System
Classification Name:
Class II §862.1345 Glucose Test System
Predicate Device:
On Call Express Blood Glucose Monitoring System ACON Laboratories Inc 10125 Mesa Rim Rd. San Diego, CA 92121
510(k) Number: K132086
Device Name: On Call Express Pro Blood Glucose Monitoring System
4
| Proprietary Name | Classification | Product
Code | Description | Common Name |
|-------------------------------------------------------------------------------------------------------|----------------------|-----------------|-----------------------------------------------------|--------------------------------|
| On Call Express Pro
Blood Glucose
Monitoring System | 862.1345
Class II | NBW | System, Test,
Blood Glucose,
Over The Counter | Glucose Test
System |
| On Call Express Pro
Blood Glucose
Meter and On Call
Express Pro Blood
Glucose Test Strips | 862.1345
Class II | CGA | Glucose Monitor | Glucose Meter &
Test Strips |
| On Call Express Pro
Glucose Control
Solution | 862.1660
Class I | JJX | Single Analyte
Control | Control Solution |
Device Description:
The On Call Express Pro Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm and forearm. The glucose measurement is achieved by using the amperometric detection method.
The test strip has a reagent system including glucose oxidase and a mediator that reacts with glucose in the whole blood sample to produce an electrical current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.
The On Call Express Pro Blood Glucose Monitoring System contains a blood glucose meter and On Call Express Pro blood glucose test strips. This is a no code meter. The On Call Express Pro Blood Glucose Monitoring System consists of the On Call Express Pro Blood Glucose Meter, On Call Express Pro Blood Glucose control solutions (Level 1 and Level 2), Carrying Case, User's Manual, Warranty Card and Logbook. Materials needed but not provided are the On Call Express Pro Blood Glucose Test strips and disposable, single use lancing devices.
Control solution(s) is/are viscosity-adjusted, buffered aqueous control solutions that contain known concentrations of d-glucose. The products are intended for use to verify the performance of the On Call Express Pro Blood Glucose Monitoring System
On Call Express Pro Blood Glucose Monitoring System has a data transfer function.
Data Port sends information to a computer via an optional data transfer cable. It allows users to view, analyze and print stored data in the meter. The data transfer cable is available for order as an optional add-on. The meter can transfer stored test results to a Windows-based personal
5
computer (PC) using an optional data transfer cable and the On Call® Diabetes Management Software (K131469). The software has been validated for use with On Call Express meter (K132086) which is the exact same device as On Call Express Pro meter.
Intended Use:
The On Call Express Pro 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. The On Call Express Pro Blood Glucose Monitoring System is intended for multiple patient use by health care professionals in health care facilities as an aid to monitoring the effectiveness of diabetes control programs. The system should only be used with single-use, auto disabling lancing devices.
The On Call Express Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates. Alternative site testing (AST) testing should only be done during steady-state times (when glucose is not changing rapidly).
The On Call Express Pro Blood Glucose Test Strips are used with the On Call Express Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.
The On Call Express Pro Blood Glucose Control Solution is for use with the On Call Express Pro Blood Glucose Meter and Strips as a quality control check to verify the accuracy of blood glucose test results.
6
Technological Characteristics:
| Feature | Specification |
|---|---|
| Measurement Range | 20 to 600 mg/dL (1.1-33.3 mmol/L) |
| Result Calibration | Plasma-equivalent |
| Sample | Fresh capillary whole blood |
| Minimum Sample Size | 0.4 µL |
| Test Time | 4 seconds |
| Power Source | One (1) CR 2032 3.0V coin cell battery |
| Battery Life | 1,000 tests for glucose testing (not considering data transfer) |
| Glucose Units of Measure | The meter is preset to mg/dL when sold in the United States. |
| Memory | Up to 300 records with time and date |
| Automatic Shutoff | 2 minutes after last action |
| Meter Size | 3.46" x 1.93" x 0.65" |
| Display Size | 1.38" x 1.26" |
| Weight | Approximately 50 g (with battery installed) |
| Operating Temperature | 41-113°F (5-45°C) |
| Operating Relative Humidity | 10-90% (non-condensing) |
| Hematocrit Range | 30-55% |
| Data Port | 9600 baud. 8 data bits. 1 stop bit. no parity |
Specification of On Call Express Pro Blood Glucose Meter:
Special conditions for use statement(s):
- . For in vitro diagnostic use only
- For Multiple Patient Use .
- Not intended for use on neonates .
- . Not for diagnosis of or screening for diabetes mellitus
- Not to be used for patients who are dehydrated, hypotensive, in shock, critically ill or in a . hyperosmolar state
- Meter should be cleaned and disinfected after use on each patient .
- System should only be used with single-use, auto-disabling lancing devices. .
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Special instrument requirements:
The On Call Express Pro Blood Glucose Meter
- . Only single-use auto-disabling lancing devices should be used with the On Call Express Pro Blood Glucose Monitoring System.
Substantial Equivalence:
Predicate device name:
On Call® Express Blood Glucose Monitoring System
Predicate 510(k) numbers:
Comparison with predicate:
| Features | On Call® Express Pro Blood
Glucose Monitoring System | On Call® Express Blood
Glucose Monitoring System
(K132086) |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Similarities | | |
| Indications for Use | The On Call® Express Pro 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 as an aid to monitoring
the effectiveness of diabetes
control programs. | Same |
| Detection Method | Amperometry | Same |
| Enzyme | FAD-Glucose Oxidase | Same |
| Calibration Coding | Non-coding | Same |
| Test Range | 20 – 600 mg/dL | Same |
| Memory | 300 records with time and date | Same |
| Sample Type | Capillary whole blood | Same |
| Sample sites | Fingertip, forearm, palm | Same |
| Sample Volume | 0.4 µL | Same |
| Sample test time | 4 seconds | Same |
| Hematocrit Range | 30 – 55% | Same |
| Altitude Study | Up to 8516 feet | Same |
| Glucose Units of
Measure | mg/dL | Same |
| Operating
Temperature | 41-113°F (5-45°C) | Same |
| Operating Relative
Humidity | 10—90% | Same |
| Data Port | One Serial data port | Same |
| Automatic Shutoff | Two minutes after last user action | Same |
| Power Source | One (1) CR 2032 3.0V coin cell
battery | Same |
| Meter Size | 3.46" x 1.93" x 0.65" | Same |
| Meter Weight | Approx. 50 g (with battery
installed) | Same |
| Battery Life | Minimum of 1,000 measurements
(without considering data transfer
and test reminder alarms) | Same |
| Differences | | |
| Intended Use/
Setting | Multiple patient use by health care
professionals in health care
facilities | Single Patient Use at home |
8
| Features | On Call® Express Pro Blood
Glucose Control Solution | On Call® Express Blood
Glucose Control Solution
(K132086) |
|---------------------|--------------------------------------------------------|-----------------------------------------------------------------|
| Indications for Use | To check that the glucose meter | Same |
9
| and test strips are working together
| properly | ||
|---|---|---|
| Matrix | Viscosity-adjusted, aqueous liquid | Same |
| Number of Levels | 3 levels (Level 0, Level 1 and | |
| Level 2) | Same |
Discussions of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Guidance documents included the "FDA Guidance for Industry In-Vitro Diagnostic Glucose Test System" and "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Laboratory Performance Testing:
The performance characteristics of the On Call Express Pro Blood Glucose Monitoring System were evaluated by performing the following studies: repeatability precision, intermediate precision, linearity, interfering agents, hematocrit effect, temperature effect evaluation - blood & control solution, low battery effect, altitude effect, sample volume, humidity effect, simulated shipping study - test strip & control solution, control value assignment, meter testing, software validation testing, electromagnetic compatibility and electrical safety testing as part of meter and strip validation testing.
10
a. Precision/Reproducibility
Within-run (Repeatability):
Venous blood was adjusted with glucose to five glucose levels (30-50, 51-110, 111-150, 151-250, 251-400 mg/dL) across the claimed range and tested on three lots of test strips on 10 meters (10 strips per meter). Ten replicates were tested per meter, test strip lot and glucose concentration (300 measurements per glucose level). Results are summarized below:
| Glucose
Level
(mg/dL) | n | Strip
Lot | Mean
(mg/dL) | SD
(mg/dL) | %CV |
|-----------------------------|-----|--------------|-----------------|---------------|-----|
| 30-50 | 100 | 1 | 43.1 | 1.20 | 2.8 |
| | | 2 | 44.3 | 1.57 | 3.5 |
| | | 3 | 43.6 | 1.44 | 3.3 |
| 51-110 | 100 | 1 | 84.6 | 1.97 | 2.3 |
| | | 2 | 86.1 | 2.48 | 2.9 |
| | | 3 | 87.0 | 2.76 | 3.2 |
| 111-150 | 100 | 1 | 127.5 | 3.30 | 2.6 |
| | | 2 | 132.6 | 3.25 | 2.5 |
| | | 3 | 128.8 | 2.81 | 2.2 |
| 151-250 | 100 | 1 | 189.0 | 3.67 | 1.9 |
| | | 2 | 187.9 | 4.38 | 2.3 |
| | | 3 | 190.7 | 5.09 | 2.7 |
| 251-400 | 100 | 1 | 316.7 | 8.66 | 2.7 |
| | | 2 | 312.5 | 10.46 | 3.3 |
| | | 3 | 306.9 | 8.58 | 2.8 |
Intermediate Precision:
Intermediate precision was evaluated using three lots of test strips and ten meters. Glucose control solutions in three concentration ranges were used (Level 2 and Level 3 or 50, 120, and 350 mg/dL). For each test strip lot, each control solution was measured once per day on 10 meters in replicates of 10, with three test strip lots for 10 days, so that 100 individual measurements were generated (300 measurements per glucose level). Results are summarized below:
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| Control Level
(mg/dL) | n | Strip Lot | Mean
(mg/dL) | SD
(mg/dL) | %CV |
|--------------------------|-----|-----------|-----------------|---------------|-----|
| Level 1
30 - 50 | 100 | 1 | 41.8 | 1.52 | 3.6 |
| | | 2 | 41.0 | 1.31 | 3.2 |
| | | 3 | 40.0 | 1.26 | 3.1 |
| Level 2
96 - 144 | 100 | 1 | 122.4 | 3.26 | 2.7 |
| | | 2 | 117.8 | 3.30 | 2.8 |
| | | 3 | 116.3 | 2.74 | 2.4 |
| Level 3
280 - 420 | 100 | 1 | 332.1 | 13.9 | 3.9 |
| | | 2 | 332.4 | 7.18 | 2.2 |
| | | 3 | 331.9 | 11.46 | 3.5 |
b) Linearity/assay reportable range:
Linearity was evaluated using 3 lots of test strips, 2 meters, and 11 venous whole blood samples with glucose levels ranging from 20-600 mg/dL (13.4, 22.0, 46.9, 83.0, 107.9, 179.0, 219.6, 328.6, 451.5, 575.5, 637.8 mg/dL), obtained by spiking pooled venous blood with a glucose solution. Each glucose level was tested with 4 test strips over 3 test strip lots. Linear regression analysis for each test strip lot compared to the YSI resulted in:
y = 0.9871x + 0.1910; R2 = 0.9991 for Test Strip Lot 1
y = 0.9755x - 0.5512; R2 = 0.9993 for Test Strip Lot 2
y = 0.9685x + 1.6098; R2 = 0.9992 for Test Strip Lot 3
The measurement range of the On Call Express Pro Blood Glucose Monitoring System is 20 -600 mg/dL.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The On Call Express Pro Blood Glucose Monitoring System is traceable to the NIST SRM 917b reference material. The method comparison study was performed using the candidate device and YSI as the reference method.
Value assignment:
The value assignment of the On Call Express Pro Blood Glucose control solutions were determined by an in-house procedure. The 3 levels of control solutions (Levels 0, 1 and 2) are prepared by gravimetric addition of glucose to achieve target glucose values and are were
12
confirmed by the YSI method. Verification of the control solutions are tested with 240 test strips and 2 On Call Express Pro meters with each level and the values were within the target ranges.
Stability:
Accelerated and Real time stability studies were conducted to assess the shelf-life and open vial stability of the control solutions and test strips with on-going real-time stability study. Unopened control solutions have a 24 month shelf life and are stable for 6 months after first opening when stored at 41-86ºF (5-30ºC ) and 10 - 90% relative humidity. The test strips should be stored at 41-86 °F (5-30 °C) and 10-90% relative humidity and are stable for 6 months after first opening when stored at 41-86 °F (5-30 °C) and 10-90% relative humidity.
d. Detection limit:
The reportable range is 20 to 600 mg/dL based on linearity studies.
e. Analytical specificity:
To assess potential interference, the sponsor used venous whole blood samples adjusted to three glucose concentration intervals of 50-60 mg/dL, 100 - 120 mg/dL and 300-350 mg/dL. Each of these samples was divided into a test pool and a control pool and each of the potential endogenous and exogenous interfering substances was added to the test pool. Each substance was tested at a minimum of two concentrations, normal/therapeutic and high/toxic concentrations. The % difference between the test sample and the control sample was calculated. The sponsor defines no significant interference as ≤ ±10 % difference relative to the control sample. Results are presented in the table below:
The labeling states the following: Interference might occur when the values of the limiting concentrations of these compounds are greater than those listed below:
Ascorbic acid > 3 mg/dL
Acetaminophen > 20 mg/dL
Bilirubin > 50 mg/dL
Uric Acid > 23.5 mg/dL
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| Potential Interfering
Substances | Concentration at
which no significant
interference is
observed (mg/dL)
(typical conc) |
|-------------------------------------|---------------------------------------------------------------------------------------------------|
| Acetaminophen | 20 |
| Ascorbic acid | 3 |
| Cholesterol | 500 |
| Conjugated-Bilirubin | 50 |
| Creatinine | 5 |
| Dopamine | 0.9 |
| Ethanol | 400 |
| Fructose | 100 |
| Galactose | 100 |
| Gentisic Acid | 10 |
| Glutathione | 0.5 |
| Hemoglobin | 500 |
| Ibuprofen | 50 |
| Lactose | 25 |
| L-Dopa | 3 |
| Maltose | 100 |
| Mannitol | 600 |
| Methyldopa | 1.5 |
| Salicylic Acid | 60 |
| Sorbitol | 70 |
| Tetracycline | 1.5 |
| Tolazamide | 10 |
| Tolbutamide | 64 |
| Triglycerides | 3000 |
| Unconjugated Bilirubin | 40 |
| Urea | 600 |
| Uric acid | 23.5 |
| Xylose | 200 |
14
Discussion of Clinical Tests Performed:
Clinical studies were conducted with lay persons and trained laboratory technicians using the On Call Express Pro Blood Glucose Monitoring System. The study data were presented evaluating the system accuracy of the On Call Express Pro Blood Glucose Monitoring System compared to the YSI Model 2300 STAT PLUS (K913806) per the ACON Clinical Study Protocol for the Blood Glucose Monitoring System. 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's Manual and the overall performance of the On Call Express Pro Blood Glucose Monitoring System.
Method comparison with predicate device:
The sponsor performed method comparison study to assess the performance of the On Call Express Pro Blood Glucose Monitoring System. Healthcare professionals tested 103 natural capillary blood samples collected from fingertips, forearms and 8 altered samples (glycolyzed or spiked) ranging in glucose concentration from 40.9 to 574 mg/dL for fingertip and 50.4 to 498 mg/dL for palm and forearm, using 36 meters and 3 lots of test strips. Reference values were obtained on an YSI 2300 STAT PLUS analyzer. Results relative to YSI are summarized in the tables below:
Fingertip:
| Linear Regression: On Call Express Pro vs. YSI Reference | ||||
|---|---|---|---|---|
| Strip Lot | Linear Regression equation | R2 | N | |
| 1 | y = 0.9486x + 5.3824 | 0.9873 | 111 | |
| 2 | y = 0.9487x + 5.1409 | 0.9862 | 111 | |
| 3 | y = 0.9441x + 5.7476 | 0.9873 | 111 |
15
Forearm:
| Linear Regression: On Call Express Pro vs. YSI Reference | |||
|---|---|---|---|
| Strip Lot | Linear Regression equation | R2 | N |
| 1 | y = 0.9918x + 5.433 | 0.9766 | 103 |
| 2 | y = 0.9863 + 5.4172 | 0.9802 | 103 |
| 3 | y= 0.9835 +7.5921 | 0.9822 | 103 |
Palm:
| Linear Regression: On Call Express Pro vs. YSI Reference | |||
|---|---|---|---|
| Strip Lot | Linear Regression equation | R2 | N |
| 1 | $y = 1.003x + 5.0984$ | 0.9761 | 103 |
| 2 | $y = 1.0096x + 3.4377$ | 0.9828 | 103 |
| 3 | $y = 1.0035x + 4.6809$ | 0.9793 | 103 |
Fingertip:
Glucose 75 mg/dL
| Lot | Within ± 5% | Within ±10% | Within ± 15% | Within ± 20% |
|---|---|---|---|---|
| 1 | 42/93 (45.2) | 66/93 (71.0%) | 93/93 (100%) | 93/93 (100%) |
| 2 | 43/93 (46.2%) | 74/93 (79.6%) | 93/93 (100%) | 93/93 (100%) |
| 3 | 30/93 (32.3%) | 71/93 (76.3%) | 93/93 (100%) | 93/93 (100%) |
Conclusion:
The laboratory testing and clinical study results demonstrate that the On Call Express Pro Blood Glucose Monitoring System is safe, effective and easy-to-use. It also demonstrates that the On Call Express Pro Blood Glucose Monitoring System meets the accuracy requirements and as such is substantially equivalent to the On Call Express Blood Glucose Monitoring System, currently sold on the U.S. market (K132086).