(362 days)
Not Found
No
The description focuses on the electrochemical reaction and electrical current measurement for glucose calculation, with no mention of AI or ML algorithms.
No
This device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels, not for treating or preventing a disease. Its purpose is to provide information for a diabetes control program, not to directly treat the condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is for the "quantitative measurement of glucose" and is intended for "in vitro diagnostic use," acting as an "aid to monitor the effectiveness of a diabetes control program." Even though it states it "should not be used for the diagnosis of or screening of diabetes," the act of "monitoring" glucose levels to assess a control program's effectiveness falls under the umbrella of diagnostic activities, as it informs medical decisions and management.
No
The device description explicitly states that the system is a "product kit consisting of a blood glucose meter, test strips, control solutions, a lancing device, lancets, and instructions for use," indicating it includes hardware components in addition to any potential software.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states: "The Super Check Plus Multi Blood Glucose Monitoring System(Model 5228-M) is intended for testing outside the body (in vitro diagnostic use)..." and "The SuperCheck Plus Blood Glucose Monitoring System(Model for self-testing outside the body(in vitro diagnostic use)...".
This clearly indicates that the device is designed to perform tests on samples taken from the human body (blood) outside of the body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) is composed of the SuperCheck Plus Multi Test Strips and SuperCheck Plus Multi Blood Glucose Meter and is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from fingettips or forearm, or in venous whole blood. The Super Check Plus Multi Blood Glucose Monitoring System(Model 5228-M) is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancets.
The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
The SuperCheck Plus Multi Test Strips are for use with the SuperCheck Plus Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from fingertips or forearm, or in venous whole blood.
The SuperCheck Plus Multi Control Solutions are for use with the SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) as a quality control check to verify that the meter and test strips are working together properly.
The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or forearm. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used by a single person and should not be shared. The SuperCheck Plus Blood Glucose Monitoring System(Model for self-testing outside the body(in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose in not changing rapidly).
The SuperCheck Plus Test Strips are for use with the SuperCheck Plus Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or forearm.
The SuperCheck Plus Control Solutions are for use with the SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) as a quality control check to verify that the meter and test strips are working together properly.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR, JJX
Device Description
The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) (also applicable to: SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M)) is a product kit consisting of a blood glucose meter, test strips, control solutions, a lancing device, lancets, and instructions for use.
The data download functionality is optionally available and sold separately. To perform a test, when a small drop of blood is applied to the end of the test strip, glucose reacts with the reagents on the test strip, producing an electrical current that is proportional to the blood glucose concentration. The glucose concentration is calculated by the glucose meter and is based on the electrical current measured. The quantitative glucose concentration (in mg/dL or mmol/L) is displayed on the display screen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingettips or forearm (for both 5228-M & 5228-S), venous whole blood (for 5228-M only)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Model 5228-M: multiple-patient use in a professional healthcare setting
Model 5228-S: single person, self-testing outside the body by people with diabetes at home
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Precision/Reproducibility: Repeatability precision (within-run precision) and intermediate precision (total precision) based on ISO 15197. Repeatability precision performed on 5 whole blood concentrations (30-50 mg/dL, 51-110 mg/dL, 111-150 mg/dL, 151-250 mg/dL, 251-400 mg/dL). For glucose concentration less than 100 mg/dL, CV values were not more than 7%. For glucose concentration more than or equal to 100mg/dL, CV values were less than 5%. Intermediate precision performed on 3 levels of control solutions with 3 lots of test strips and 10 meters for 10 days. CV values were less than 5%.
- Linearity/assay reportable range: Linearity study performed using capillary whole blood samples spiked to 11 concentration levels from 20-600 mg/dL. Linear regression showed a correlation of r-0.9998 compared to the reference method (YSI analyzer) over the range 21 mg/dL to 592 mg/dL. Measuring range of the SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring Systems is 20-600 mg/dL.
- Operating Temperature and Humidity Study: Confirmed operation for temperature range of 10-40°C(50-104°F) and relative humidity range of 20-80%, noncondensing.
- Analytical specificity: Nine endogenous substances and thirteen exogenous substances analyzed at two concentrations of glucose and interferent according to NCCLS EP 7. For glucose concentrations less than 100mg/dL, average difference between tested and control sample is within 10 mg/dL. For glucose concentrations more than or equal to 100 mg/dL, average difference between tested and control sample is within 10%.
- Hematocrit Study: Nine hematocrit levels (20-60%) at 3 spiked target glucose concentrations evaluated. No significant hematocrit effect from 20%-60% for samples with concentration levels over dynamic range (20-600 mg/dL).
- Altitude Study: Venous blood samples spiked to 3 glucose concentrations performed at 33 ft and 10,744 ft. No significant effect on blood glucose measurement up to 10,744 ft.
- Sample volume study: Blood volume test performed from 0.5µl to 3.0ul. Error message displayed for insufficient sample volume of 0.7ul. Claims sample volume of ≥0.7ul produces accurate results.
- Meter reliability study: Performed before and after challenge including mechanical resistance to drop and vibration and protection against exposure to temperature and humidity levels. All results within criteria, demonstrating accurate results within claimed limits.
- EMC and electrical safety study: Performed Electromagnetic Interference and Safety Test to verify conformity to IEC/EN 61010-1, IEC/EN 61010-2-101, IEC/EN 61326-1 and IEC/EN 61326-2-6 standards. System complied with standards.
- Infection control studies: Robustness study demonstrated no change in performance or external materials after 10,950 cleaning/disinfection cycles (multiple-patient use) and 5475 cleaning/156 disinfection cycles (single-patient use) to simulate 3 years of use. Disinfection efficacy studies showed complete inactivation of hepatitis B (HBV) with Clorox® Germicidal Wipes.
- System Accuracy Study: Compared to YSI 2300 (reference method). Sample size: 151 subjects. Accuracy met acceptance criteria.
- User Performance Study: Sample size: 129 participants. Demonstrated accuracy of SuperCheck Plus (Model 5228-S). Results met acceptance criteria and were easy to use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2015
BIOTEST MEDICAL CORP. YUHUA CHEN NO.3-2, CHIEN-KUO ROAD, TEPZ, TANTZU, 427 TAICHUNG, TAIWAN
Re: K141351
Trade/Device Name: SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S), SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JJX Dated: May 20, 2014 Received: May 22, 2014
Dear Yuhua Chen:
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
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/ResourcesforYou/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) K141351
Device Name
SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M)
Indications for Use (Describe)
The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) is composed of the SuperCheck Plus Multi Test Strips and SuperCheck Plus Multi Blood Glucose Meter and is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from fingettips or forearm, or in venous whole blood. The Super Check Plus Multi Blood Glucose Monitoring System(Model 5228-M) is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancets.
The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
The SuperCheck Plus Multi Test Strips are for use with the SuperCheck Plus Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from fingertips or forearm, or in venous whole blood.
The SuperCheck Plus Multi Control Solutions are for use with the SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) as a quality control check to verify that the meter and test strips are working together properly.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K141351
Device Name
SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S)
Indications for Use (Describe)
The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or forearm. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used by a single person and should not be shared. The SuperCheck Plus Blood Glucose Monitoring System(Model for self-testing outside the body(in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose in not changing rapidly).
The SuperCheck Plus Test Strips are for use with the SuperCheck Plus Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or forearm.
The SuperCheck Plus Control Solutions are for use with the SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) as a quality control check to verify that the meter and test strips are working together properly.
Type of Use (Select one or both, as applicable)
| ☐ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☒ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
(Per 21 CFR 807.92)
-
- Submitter Information C
| Company Name | Biotest Medical Corporation |
|---|---|
| Address | No. 3-2 , Chien-kuo road, TEPZ Tantzu, 427 |
| Taichung, Taiwan | |
| Contact Person | Yuhua Chen |
| Phone | 886-4-2532-6668 |
| Fax | 886-4-2532-6593 |
| yuhuachen@mail.biotestsystems.com | |
| Date Prepared | May 14, 2015 |
-
- Device Name Proprietary Name
Common Name Classification Number
- Device Name Proprietary Name
Classification Panel Product Code Regulation Number
-
- Predicate Device Proprietary Name Common Name Manufacturer 510(k) Number
SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) Blood Glucose Test System System, Test, Blood Glucose, Over the Counter Chemistry NBW, LFR, JJX 862.1345
- Predicate Device Proprietary Name Common Name Manufacturer 510(k) Number
ACCU-CHEK Performa System Blood Glucose Test System Roche Diagnostics Corporation K070585
-
- Device Description
The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) (also applicable to: SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M)) is a product kit consisting of a blood glucose meter, test strips, control solutions, a lancing device, lancets, and instructions for use.
- Device Description
5
The data download functionality is optionally available and sold separately. To perform a test, when a small drop of blood is applied to the end of the test strip, glucose reacts with the reagents on the test strip, producing an electrical current that is proportional to the blood glucose concentration. The glucose concentration is calculated by the glucose meter and is based on the electrical current measured. The quantitative glucose concentration (in mg/dL or mmol/L) is displayed on the display screen.
5. Intended Use
For single patient use
SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S)
The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used for the quantitative measurement of qlucose in fresh capillary whole blood drawn from the fingertips or forearm. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used by a single person and should not be shared. The SuperCheck Plus Blood Glucose Monitoring System(Model 5228-S) is intended for self-testing outside the body(in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose in not changing rapidly). The SuperCheck Plus Test Strips are for use with the SuperCheck Plus Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or forearm.
The SuperCheck Plus Control Solutions are for use with the SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) as a quality control check to verify that the meter and test strips are working together properly.
For multiple patient use SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M)
The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) is composed of the SuperCheck Plus Multi Test Strips and SuperCheck Plus Multi Blood Glucose Meter and is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from fingertips or forearm, or in venous whole blood. The
6
SuperCheck Plus Multi Blood Glucose Monitoring System(Model 5228-M) is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancets.
The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
The SuperCheck Plus Multi Test Strips are for use with the SuperCheck Plus Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from fingertips or forearm, or in venous whole blood.
The SuperCheck Plus Multi Control Solutions are for use with the SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) as a quality control check to verify that the meter and test strips are working together properly.
| Similarities | ||
|---|---|---|
| ltem | SuperCheck Plus Blood Glucose | ACCU-CHEK Performa |
| Monitoring System(Model | System (Predicate device) | |
| 5228-S) | ||
| SuperCheck Plus Multi Blood | ||
| Glucose Monitoring System | ||
| (Model 5228-M) | ||
| (Proposed devices) | ||
| Enzyme | FAD- glucose dehydrogenase | Glucose dehydrogenase with |
| nitrosoaniline mediator | ||
| Measurement | Same | Amperometric method |
| principle | ||
| Sample type | Same | Fresh capillary whole blood |
| Venous whole blood | ||
| Power | Same | Two 1.5V AAA alkaline |
| batteries |
6. Comparison to Predicate Device
7
| Glucose units | Same | Either mg/dL or mmol/L |
|---|---|---|
| Strip vial open time | Same | 90 days |
| Test time | Same | 5 seconds |
| Memory | Same | 500 measurements with day and time |
| PC link | Same | Yes |
| Strip storage condition | 2~30℃ (35.6-86°F)/20-80%RH | 2~30℃(35.6-86°F) |
| Differences | ||
| Weight | 72g | 62g |
| Dimensions | 100mm(L)x50mm(W)x20mm(H) | 93mm(L)x52mm(W)x22mm(H) |
| Test volume | 0.7µL | 0.6µL |
| Test Range | 20-600 mg/dL | 10-600 mg/dL |
| Operating condition | 10~40℃ (50-104°F) | 6~44℃(39.2-111.2°F) |
| Operating condition | 20~80% RH (non-condensing) | 10~90% RH |
| Alternate site capability | Forearm | Palm, forearm, upper arm, thigh, and calf |
| Hematocrit range | 20-60% | 10-70% |
| Coding | No | Yes (A Code Key is provided with each box of test strips to calibrate the meter for that strip lot.) |
-
- Non-Clinical Performance Characteristics
A brief description of analytical performance for these studies listed below is included in this submission.
- Non-Clinical Performance Characteristics
-
a. Precision/Reproducibility
Precision/Reproducibility evaluations were conducted by performing repeatability precision (within-run precision) and intermediate precision (total precision) based on ISO 15197. Repeatability precision was performed on 5 whole blood concentrations (30-50 mg/dL, 51-110 mg/dL, 111-150 mg/dL, 151-250 mg/dL, 251-400 mg/dL). For glucose concentration was less than 100 mg/dL, the test results of CV values were not more than 7%. For glucose concentration was more than or
8
equal to 100mg/dL, the test results of CV values were less than 5%. Intermediate precision was performed on 3 levels of control solutions (30-50mg/dL, 96-144mg/dL and 280-420mg/dL) with 3 lots of test strips and 10 meters for 10 days. The test results of CV values were less than 5%.
b. Linearity/assay reportable range
The linearity study was performed using capillary whole blood samples. The capillary samples were spiked to 11 concentration levels from 20-600 mg/dL. Linear regression showed a correlation of r-0.9998 compared to the reference method (YSI analyzer) over the range 21 mg/dL to 592 mg/dL.
The measuring range of the SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring Systems is 20-600 mg/dL.
c. Operating Temperature and Humidity Study
The study confirmed the operation of the SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring System for temperature range of 10-40°C(50-104°F) and the relative humidity range of 20-80%, noncondensing.
d. Analytical specificity
Nine endogenous substances and thirteen exogenous substances were analyzed at two concentrations of glucose and interferent according to NCCLS EP 7. For glucose concentrations is less than 100mg/dL, the average difference between the tested and the control sample is within 10 mg/dL. For glucose concentrations is more than or equal to 100 mg/dL, the average difference between the tested and the control sample is within 10%. Results are presented in the table below:
| Interfering substances | Highest concentration at which
no interference is observed |
|------------------------|---------------------------------------------------------------|
| Endogenous substances | |
| Billrubin | 20.8 mg/dL |
| Cholesterol | 648.1 mg/dL |
| Creatinine | 5.95 mg/dL |
| Fructose | 30 mg/dL |
9
| Galactose | 60 mg/dL |
|---|---|
| Glutathione | 23.5 mg/dL |
| Glyceryl Tributyrate | 3039.3 mg/dL |
| Hemoglobin | 20 g/dL |
| Uric Acid | 9.5 mg/dL |
| Exogenous substances | |
| Acetaminophen | 20 mg/dL |
| Ascorbic Acid | 4.5 mg/dL |
| Dopamine | 1.25 mg/dL |
| Gentistic acid | 6.75 mg/dL |
| Ibuprofen | 50 mg/dL |
| L-Dopa | 1.9 mg/dL |
| Maltose | 1000 mg/dL |
| Methyl Dopa | 1.5 mg/dL |
| Pralidoxime Iodide(PAM) | 62.5 mg/dL |
| Salicylate | 115.5 mg/dL |
| Tolazamide | 3.8 mg/dL |
| Tolbutamide | 64 mg/dL |
| Xylose | 6.3 mg/dL |
The accuracy study of EDTA anticoagulated whole blood samples used with SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring System compared to results obtained using a capillary sample collected in heparin with a reference method (YSI glucose analyzer) were evaluated. The result of the study was shown that SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring System produce accurate glucose results when the blood samples are collected in EDTA tube.
-
e. Hematocrit Study
Nine hematocrit levels of 20, 25, 30, 35, 42, 45, 50, 55 and 60% at 3 spiked target glucose concentrations were evaluated. The study showed no significant hematocrit effect from 20%-60% for samples with concentration levels over dynamic range (20-600 mg/dL). -
f. Altitude Study
Venous blood samples were spiked to 3 glucose concentration (30-50 mg/dL, 96-144 mg/dL, 280-420 mg/dL). The samples were performed at 33 ft and 10,744 ft. Values were compared to the YSI 2300 (reference
10
method). The results demonstrated that altitudes up to 10,744 ft have no significant effect on blood glucose measurement from the SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring Systems.
g. Sample volume study
The blood volume test was performed from 0.5µl to 3.0ul by using the blood samples spiked to produce 3 glucose concentrations (30-50 mg/dL, 96-144 mg/dL, 280-420 mg/dL) for verifying the performance of test strip.
The results showed that error message was displayed for insufficient sample volume of 0.7ul; therefore the SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring Systems claim that sample volume of ≥0.7ul produces accurate blood glucose results.
h. Meter reliability study
The reliability test was performed before and after challenge including mechanical resistance to drop and vibration and protection against exposure to temperature and humidity levels. All results were within the criteria. It demonstrates that SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) meters produced accurate results within its claimed temperature and humidity limits.
i. EMC and electrical safety study
SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring Systems by performing Electromagnetic Interference and Safety Test to verify the product conform IEC/EN 61010-1, IEC/EN 61010-2-101, IEC/EN 61326-1 and IEC/EN 61326-2-6 standards. All the results revealed the system was complied with the above related standards.
Infection control studies i.
The systems are intended for single-patient use (SuperCheck Plus (5228-S)) and multiple-patient use (SuperCheck Plus Multi (5228-M)). Cleaning and disinfection can be accomplished by wiping the meter with Clorox® Germicidal Wipes (EPA Reg. No. 67619-12). The robustness study was conducted and the results demonstrated that there was no
11
change in performance or in the external materials of the meter after 10,950 cleaning and disinfection cycles to simulate 3 years of use for multiple-patient use and after 5475 cleaning cycle and 156 disinfection cycles to simulate 3 years of use for single-patient use.
Disinfection efficacy studies were performed on the materials comprising the meter by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B (HBV) with chosen disinfectant, HEALTHCARETM Bleach Germicidal Wipes by the Clorox Company (EPA registered # 67619-12).
8. Clinical Performance Characteristics
- a. System Accuracy Study
The accuracy study of SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring Systems was compared to YSI 2300 (reference method). A total of 151 subjects were recruited. The study result demonstrates that the accuracy of SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring Systems met the acceptance criteria.
b. User Performance Study
The study was performed with 129 participants to demonstrate the accuracy of the SuperCheck Plus (Model 5228-S) Blood Glucose Monitoring System. Participants, who were able to read the User's Manual in English, were instructed to read the manual and perform testing on the finger and the forearm. The study results met the acceptance criteria and according to the results of questionnaire, SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring Systems are easy to use for participants.
9. Conclusion
Laboratory testing and clinical testing results of SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) and SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) demonstrated satisfactory and support their Indications for Use. It also demonstrates that SuperCheck Plus (Model 5228-S) and SuperCheck Plus Multi (Model 5228-M) are substantial equivalence to the predicate.