(925 days)
Not Found
No
The summary describes a standard blood glucose monitoring system and its performance testing. There is no mention of AI or ML in the device description, intended use, or performance studies. The testing focuses on analytical performance, interference, and usability, which are typical for this type of device and do not indicate the use of AI/ML for glucose measurement or interpretation.
No.
The device is intended for the quantitative determination of glucose in blood samples, which is a diagnostic purpose, not a therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section states: "The XPER Technology PREMIUM Pro Blood Glucose Monitoring System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in fresh capillary whole blood samples from the fingertips... The system is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia." It also mentions "in vitro diagnostic."
No
The device description explicitly states that the system consists of a Blood Glucose Meter and Blood Glucose Test Strips, which are hardware components. The performance studies also detail testing and validation of these physical components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The XPER Technology PREMIUM Pro Blood Glucose Monitoring System is intended for point-of-care, in vitro diagnostic, multiple-patient use..."
- Nature of the Test: The system performs a "quantitative determination of glucose in fresh capillary whole blood samples." This is a test performed on a biological sample (blood) outside of the body, which is the definition of an in vitro diagnostic test.
- Purpose: The system is used "as an aid in monitoring the effectiveness of glucose control," which is a diagnostic purpose related to a medical condition (dysglycemia).
N/A
Intended Use / Indications for Use
The XPER Technology PREMIUM Pro Blood Glucose Monitoring System consists of the XPER Technology PREMIUM Pro Blood Glucose Meter and XPER Technology PREMIUM Pro Blood Glucose Test Strips.
The XPER Technology PREMIUM Pro Blood Glucose Monitoring System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in fresh capillary whole blood samples from the fingertips in endocrinology clinic laboratories and physician office laboratories.
The system should only be used with single-use, auto-disabling lancing devices when performing a fresh capillary whole blood sample from the fingertip.
The system is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.
The system is not intended for use on patients receiving intensive medical intervention/therapy.
The system is not intended for use in acute care, nursing facilities, skilled nursing facilities or hospital settings. The system is not intended for use on neonates.
Product codes (comma separated list FDA assigned to the subject device)
PZI
Device Description
The XPER Technology PREMIUM Pro Blood Glucose Monitoring System consists of the XPER Technology PREMIUM Pro Blood Glucose Meter, the XPER Technology PREMIUM Pro Blood Glucose Test Strips, and the TaiDoc Blood Glucose Control Solutions. This system is a multiplepatient use for the quantitative determination of glucose in capillary whole blood samples from the fingertips in endocrinology clinic laboratories and physician office laboratories as an aid in monitoring the effectiveness of glucose control. The TaiDoc Blood Glucose Control Solutions are used to check that the meter and test strips are working together properly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
endocrinology clinic laboratories and physician office laboratories.
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
A clinical study was conducted at 3 U.S. sites with 10 operators and 6 Taiwan sites with 18 operators that had environments and operators representative of endocrinology clinic laboratories and physician office laboratories.
The capillary blood samples from 414 patients were measured and the results were compared to the YSI Model 2300 Glucose Analyzer.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical and clinical studies were conducted to test, verify and validate the performance of the candidate device according to FDA Guidance issued on September 29, 2020: Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use. Results from these studies show that the device performance is substantially equivalent.
Non-Clinical Testing Summary:
- Precision: Within-run and intermediate precision were performed to evaluate imprecision of the candidate device across the glucose measuring range (10-800 mg/dL).
- Intermediate precision: 10 days, 7 levels of control solutions, 3 lots of test strips, 10 meters tested daily (one measurement per meter/day for one test strip lot/level). Total 2100 measurements.
- Within-run precision: 1 day, 7 levels of venous blood samples (glucose concentrations achieved by adding concentrated glucose solutions), 3 lots of test strips, 10 meters tested (10 measurements per meter). Total 2100 measurements.
- Key results: All test results were within acceptance criteria.
- Lineariy: Evaluated 11 blood glucose levels. Target glucose concentrations verified by YSI-2300 reference analyzer. 5 meters worked with 3 test strip lots were tested.
- Key results: All test results were within acceptance criteria, demonstrating linearity across the claimed measuring range 10-800 mg/dL.
- "Lo" display for 800 mg/dL: 3 test strip lots and 5 meters were tested with venous blood samples above and below the measuring range. All meters met acceptance criteria.
- Hematocrit: 13 levels of hematocrit were evaluated across the claimed range 10% - 70%. Bias against YSI-2300 and average of blood glucose value on 42% hematocrit were calculated.
- Key results: All test results were within acceptance criteria, demonstrating no effect on performance within the claimed hematocrit range.
- Interference: Effect of 58 endogenous and exogenous substances evaluated. 3 target blood glucose ranges were tested. Bias against YSI-2300 calculated.
- Key results: Xylose in blood can give falsely elevated results. Pralidoxime Iodide level > 5 mg/dL may affect glucose results.
- Disinfection validation test: Performed by Microbac Laboratories using duck hepatitis B virus and Clorox Healthcare ™ Bleach Germicidal Wipe (EPA No.: 67619-12).
- Key results: Reduction of virus was within acceptance criteria, complete inactivation achieved.
- Robustness test: Demonstrated ability to withstand multiple cleaning and disinfection cycles. Number of cycles: 27,500 (15 cycles/day x 365 days/year x 5 years). Clorox Healthcare ™ Bleach Germicidal Wipe used. Performance and physical inspection at 0, 13,750, and 27,500 cycles.
- Key results: All test results within acceptance criteria, demonstrates continued intended use under 27,500 cycles.
- Flex studies: Performed to confirm fail-safe mechanisms under stress conditions.
- Studies included: Drop and vibration, Sample Perturbation Study Procedure, Intermittent Sampling, Blood Volume Test, Used Test Strips, Error Codes for Samples Outside the Measuring Range, Clotted samples, Incorrect Test Strips, Test Strips Removal Verification, Altitude.
- Key results: All test results were within acceptance criteria, risks of imprecisions effectively mitigated under normal use.
- Stability: Test strip vial stability evaluated (open vial and close vial real time stability).
- Key results: Protocols and acceptance criteria found acceptable, supporting labeling claims for 12 months stability at recommended storage conditions (35.6-86°F (2-30°C) and 10-90% relative humidity).
Clinical study summary:
- A clinical study was conducted at 3 U.S. sites and 6 Taiwan sites with 10 and 18 operators respectively, representative of endocrinology clinic laboratories and physician office laboratories environments.
- Sample size: 414 patients.
- Comparison: Candidate device results compared to YSI Model 2300 Glucose Analyzer.
- Accuracy for blood glucose concentrations 300 mg/dL) and lower (300 mg/dL).
- Method: Blood samples collected and allowed to glycolyze or spiked with glucose. Compared to YSI-2300.
- Medications and Medical Conditions: Medical conditions and medications identified from 9 clinical locations.
- Key results: Participants received approximately 69 medications (over 17 parent drug classes, over 17 drug subclasses, up to 4 different drugs per patient). Conditions and medications were similar to common patient medications/conditions in US physician offices and endocrinology clinics.
- Usability: Conducted during clinical study to evaluate ease of use/understanding. Owner's Manual, Quick Reference Instructions (including Bluetooth pairing) provided. Operators completed a questionnaire.
- Key results: Candidate device is easy to use, labeling easy to understand.
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
November 19, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
TaiDoc Technology Corporation Jacky Chou Vice President B1-7F, No.127, Wugong 2nd Rd., Wugu District New Taipei City, 24888 Taiwan
Re: K221349
Trade/Device Name: XPER Technology PREMIUM Pro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: PZI Dated: March 11, 2024 Received: March 11, 2024
Dear Jacky Chou:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joshua Balsam -S
Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K221349
Device Name
XPER Technology PREMIUM Pro Blood Glucose Monitoring System
Indications for Use (Describe)
The XPER Technology PREMIUM Pro Blood Glucose Monitoring System consists of the XPER Technology PREMIUM Pro Blood Glucose Meter and XPER Technology PREMIUM Pro Blood Glucose Test Strips.
The XPER Technology PREMIUM Pro Blood Glucose Monitoring System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in fresh capillary whole blood samples from the fingertips in endocrinology clinic laboratories and physician office laboratories.
The system should only be used with single-use, auto-disabling lancing devices when performing a fresh capillary whole blood sample from the fingertip.
The system is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.
The system is not intended for use on patients receiving intensive medical intervention/therapy.
The system is not intended for use in acute care, nursing facilities, skilled nursing facilities or hospital settings. The system is not intended for use on neonates.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
In accordance with the requirements of 21 CFR 807.92, this summary is being provided to serve as the basis for the substantial equivalence determination.
Submitter Information
| Manufacturer | TaiDoc Technology Corporation |
|---|---|
| Address | B1-7F, No.127, Wugong 2nd Rd., Wugu District, |
| New Taipei City, Taiwan 24888 | |
| Establishment Registration No. | 3004145393 |
| Date Prepared | November 18, 2024 |
| Correspondent | TaiDoc Technology Corporation |
| Correspondent Contact | Jacky Chou |
| Title | Vice President |
| Phone Number | +886-2-6625-8188 |
| Fax Number | +886-2-6625-0868 |
| jacky.chou@taidoc.com.tw |
Candidate Device Information
| Proprietary Name | XPER Technology PREMIUM Pro Blood Glucose
Monitoring System |
|----------------------|-----------------------------------------------------------------------|
| Common Name | Glucose Test System |
| 510(k) Number | K221349 |
| Product Code | PZI, Prescription Use Blood Glucose Meter For
Near-Patient Testing |
| Classification panel | Clinical Chemistry |
| Classification | 2 |
| Regulation Number | 21 CFR §862.1345 |
Predicate Device Information
| Manufacturer | Arkray, Inc. |
|---|---|
| Proprietary Name | Assure® Titanium Blood Glucose Monitoring System |
| Common Name | Glucose Test System |
| 510(k) Number | K200788 |
5
Indications for Use
The XPER Technology PREMIUM Pro Blood Glucose Monitoring System consists of the XPER Technology PREMIUM Pro Blood Glucose Meter and XPER Technology PREMIUM Pro Blood Glucose Test Strips.
The XPER Technology PREMIUM Pro Blood Glucose Monitoring System is intended for point-ofcare, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in fresh capillary whole blood samples from the fingertips in endocrinology clinic laboratories and physician office laboratories.
The system should only be used with single-use, auto-disabling lancing devices when performing a fresh capillary whole blood sample from the fingertip.
The system is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.
The system is not intended for use on patients receiving intensive medical intervention/therapy.
The system is not intended for use in acute care, nursing facilities, skilled nursing facilities or hospital settings.
The system is not intended for use on neonates.
Device Description
The XPER Technology PREMIUM Pro Blood Glucose Monitoring System consists of the XPER Technology PREMIUM Pro Blood Glucose Meter, the XPER Technology PREMIUM Pro Blood Glucose Test Strips, and the TaiDoc Blood Glucose Control Solutions. This system is a multiplepatient use for the quantitative determination of glucose in capillary whole blood samples from the fingertips in endocrinology clinic laboratories and physician office laboratories as an aid in monitoring the effectiveness of glucose control. The TaiDoc Blood Glucose Control Solutions are used to check that the meter and test strips are working together properly.
Test Principle
The XPER Technology PREMIUM Pro Blood Glucose Monitoring System is designed to quantitatively measure the amount of blood sugar (glucose) in fresh capillary whole blood from fingertips. The glucose measurement is achieved by using the amperometric detection method that uses flavin adenine dinucleotide-dependent glucose dehydrogenase enzyme (FAD-GDH) based chemistry. Once a drop of blood sample is applied to the test strip, the blood sample is pulled into the test strip by capillary action. The sample reacts chemically with the enzyme, generating electrons and producing an electric current that is proportional to the concentration of glucose in the sample. After the reaction time, the meter calculates and then displays the glucose concentration on LCD. The XPER Technology PREMIUM Pro Blood Glucose Monitoring System reports the glucose results in plasma equivalents.
6
Summary of Technological Characteristics and Comparison to the Predicate Device
The XPER Technology PREMIUM Pro Blood Glucose Monitoring System is substantially equivalent to the predicate device in terms of technological characteristics and similar in intended use. The similarities and differences between the predicate and candidate devices are summarized in Table 1 and Table 2.
| Predicate Device K200788 | Candidate Device K221349 | |
|---|---|---|
| Characteristic | Assure® Titanium Blood Glucose | |
| Monitoring System | XPER Technology PREMIUM | |
| Pro Blood Glucose Monitoring | ||
| System | ||
| Operation principle | Electrochemical biosensor | |
| technology | Identical | |
| Detection method | Amperometric glucose enzyme | Identical |
| Sample type | Fresh capillary whole blood | Identical |
| Calibration | Automatic, no Calibration Code | Identical |
| Sample Size | 0.5 µL | Identical |
| Hematocrit Range | 10-70% | Identical |
| Handheld | Yes | Identical |
| User interface | Screen and buttons | Identical |
| Memory capacity | 1000 measurements | Identical |
| Power source | 2 AAA Batteries | Identical |
| Table 1. Similarities between the Predicate and Candidate Device | |||
|---|---|---|---|
| Predicate Device K200788 | Candidate Device K221349 | |
|---|---|---|
| Characteristic | Assure® Titanium Blood Glucose | |
| Monitoring System | XPER Technology PREMIUM | |
| Pro Blood Glucose Monitoring | ||
| System | ||
| Indications for Use | The Assure Titanium Blood Glucose | |
| Monitoring System consists of the Assure | ||
| Titanium Blood Glucose meter and the | ||
| Assure Titanium Blood Glucose test strips. | ||
| The Assure Titanium Blood Glucose | ||
| Monitoring System is intended for use in | ||
| the quantitative measurement of glucose in | ||
| fresh capillary whole blood samples drawn | ||
| from the fingertips. The system is intended | ||
| for in vitro diagnostic, point of care use in | ||
| endocrinology clinics and nursing or skilled | ||
| nursing facilities, for multiple patient use. | ||
| This system should only be used with | ||
| single-use, auto-disabling lancing devices | ||
| for drawing finger stick capillary blood. | ||
| The system is not intended for the | ||
| screening or diagnosis of diabetes mellitus | ||
| but is indicated for use in determining | ||
| dysglycemia. The system is not intended for | ||
| use in acute care or hospital settings. The | ||
| system is not intended for neonatal use. The | ||
| system is for prescription use only. | The XPER Technology PREMIUM Pro | |
| Blood Glucose Monitoring System consists | ||
| of the XPER Technology PREMIUM Pro | ||
| Blood Glucose Meter and XPER | ||
| Technology PREMIUM Pro Blood Glucose | ||
| Test Strips. | ||
| The XPER Technology PREMIUM Pro | ||
| Blood Glucose Monitoring System is | ||
| intended for point-of-care, in vitro | ||
| diagnostic, multiple-patient use for the | ||
| quantitative determination of glucose in | ||
| fresh capillary whole blood samples from | ||
| the fingertips in endocrinology clinic | ||
| laboratories and physician office | ||
| laboratories. | ||
| The system should only be used with | ||
| single-use, auto-disabling lancing devices | ||
| when performing a fresh capillary whole | ||
| blood sample from the fingertip. | ||
| The system is not intended for the | ||
| screening or diagnosis of diabetes mellitus | ||
| but is indicated for use in determining | ||
| dysglycemia. |
7
| Characteristic | Predicate Device K200788
Assure® Titanium Blood Glucose
Monitoring System | Candidate Device K221349
XPER Technology PREMIUM
Pro Blood Glucose Monitoring
System |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Population
Limitations | Not intended for neonatal use, acute
care or hospital settings, nor for use
with patients receiving intensive
medical intervention/therapy. | The system is not intended for use on
patients receiving intensive medical
intervention/therapy.
The system is not intended for use in acute
care, nursing facilities, skilled nursing
facilities or hospital settings.
The system is not intended for use on
neonates.
Not intended for use neonatal use, acute
care, nursing facilities, skilled nursing
facilities, hospital settings, nor for use
with patients receiving intensive
medical intervention/therapy. |
| Wireless Data
Communication | None | Bluetooth Low Energy (BLE) |
| Enzyme | Glucose oxidase ( Aspergillus niger
sourced) | FAD-Glucose dehydrogenase ( E. coli ) |
| Meter Size | 4.7 x 2.4 x 1.2 inch | 102.5(L) x 59.6(W) x 21.8(H) mm |
| Meter Weight | 4.1 oz with batteries | 64.4 g (without batteries) |
| Measuring Range | 10-600 mg/dL | 10-800 mg/dL |
| Time to Result | 7 seconds | 5 seconds |
| Operating
temperature | 46° to 104°F (8° to 40°C) | 46.4° to 113°F (8° to 45°C) |
Summary of Testing
Non-clinical and clinical studies were conducted to test, verify and validate the performance of the candidate device according to FDA Guidance issued on September 29, 2020: Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use. Results from these studies show that the device performance is substantially equivalent.
Non-Clinical Testing Summary:
Precision
Within-run and intermediate precision were performed to evaluate imprecision of the candidate device across the glucose measuring range (10-800 mg/dL).
The intermediate precision test was conducted for 10 days and 7 levels of control solutions and 3 lots of test strips were tested. 10 meters were tested for each day and each meter produced one measurement per day for one test strip lot and one level. Total 2100 measurements were obtained by meters for 3 lots of test strip in the end of test.
In within-run precision test. 7 levels of venous blood samples and 3 lots of test strips were tested. The venous blood samples were added to concentrated glucose solutions to achieve the glucose concentration ranges of 7 levels. The within-run precision test was conducted in 1 day, and 10 meters were tested and 10 measurements were produced per meter. Total 2100 measurements were obtained by meters for 3 lots of test strip in the end of test.
The precision data demonstrates that all test results were within acceptance criteria-
Linearity
The linearity was performed in accordance with CLSI Document EP6-A" Evaluation of the Linearity of Quantitative Measurement: A Statistical Approach; An Approved Guideline."
11 blood glucose levels were evaluated and the target glucose concentrations were verified by the YSI-2300 reference analyzer. The 5 meters worked with 3 test strip lots were tested. The linearity
8
data analysis showed that all test results were within acceptance criteria, which demonstrate the linearity of candidate device across the claimed measuring range 10-800 mg/dL.
3 test strip lots and 5 meters were tested with venous blood samples at glucose levels above and below the claimed measuring range. All meters met the acceptance criteria to display "Lo" at glucose levels 800 mg/dL.
Hematocrit
The 13 levels of hematocrit were evaluated on the candidate device across the claimed hematocrit range 10% - 70%. The bias against YSI-2300 and the average of blood glucose value on 42% hematocrit were calculated to assess the hematocrit effect. All test results were within acceptance criteria, which demonstrate the claimed hematocrit range 10% - 70% doesn't affect the performance of candidate device.
Interference
The effect of 58 endogenous and exogenous substances that are expected in the intended use environment were evaluated on the candidate device. The 3 target blood glucose ranges were tested, and the bias against the YSI-2300 was calculated to assess the interfering effect for each substance. For each concentration of potential interfering substances, average percent bias to untreated control samples and 95% confidence intervals were calculated. The interference data showed the highest concentration with no interference and the maximum test concentration of each interfering substances tested. According to the interference data, Xylose in the blood can give falsely elevated results, and Pralidoxime Iodide level to > 5 mg/dL may affect the glucose results.
Disinfection validation test
The disinfection validation test was performed by Microbac Laboratories.
The duck hepatitis B virus was used to evaluate the efficacy of Clorox Healthcare ™ Bleach Germicidal Wipe (EPA No.: 67619-12) on candidate device. The reduction of virus was within acceptance criteria, and the complete inactivation of virus were achieved, which demonstrate the Clorox Healthcare ™ Bleach Germicidal Wipe (EPA No.: 67619-12) can effectively eliminate duck hepatitis B virus from the surface of candidate device.
Robustness test
Robustness were performed to demonstrate that the candidate device can withstand multiple cleaning and disinfection cycles within 5 years of shelf life.
The number of cleaning and disinfection cycles performed for this testing was based 15 cleaning and disinfection cycles per day for 5 years for a total of 27,500 cycles (15 cycles per day x 365 days per year x 5 years = 27,375 cycles of cleaning and disinfection). The Clorox Healthcare ™ Bleach Germicidal Wipe (EPA No.: 67619-12) was used in this test, and the performance and physical inspection are performed at start (0 cycle), middle (13.750 cycles) and end point (27,500 cycles). All test results are within acceptance criteria, which demonstrates that the candidate device maintains its intended use under 27,500 cycles of cleaning and disinfection by using Clorox Healthcare 110 Bleach Germicidal Wipe.
Flex studies
The following flex studies were performed to confirm the fail-safe mechanisms of candidate device is effective under stress conditions. All test results were within acceptance criteria, which demonstrate the risks of imprecisions are effectively mitigated under normal use.
- · Drop and vibration
- Sample Perturbation Study Procedure
- · Intermittent Sampling
- Blood Volume Test
- · Used Test Strips
- · Error Codes for Samples Outside the Measuring Range
- · Clotted samples
9
- Incorrect Test Strips
- · Test Strips Removal Verification
- Altitude
Stability
The test strip vial stability is evaluated using open vial and close vial real time stability. The protocols and acceptance criteria are reviewed and found acceptable to support the labeling claims that the test strips are stable after first being opened, and that closed vials are stable for 12 months at the recommended storage temperature 35.6-86°F (2-30°C) and 10-90% relative humidity.
Clinical study summary:
A clinical study was conducted at 3 U.S. sites with 10 operators and 6 Taiwan sites with 18 operators that had environments and operators representative of endocrinology clinic laboratories and physician office laboratories.
The capillary blood samples from 414 patients were measured and the results were compared to the YSI Model 2300 Glucose Analyzer.
The Table 3 and Table 4 show differences in glucose values between the candidate device and the YSI method.
| Difference range between the
true blood glucose level and the
candidate device results. | Within
±5 mg/dL | Within
±10 mg/dL | Within
±12 mg/dL | Within
±15 mg/dL | Exceeds
±15 mg/dL |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|---------------------|---------------------|---------------------|----------------------|
| The percentage (numbers) of
samples for which the difference
between the candidate device
and the YSI-2300 were within
the difference range shown in
the top row. | 8/13
(61.5%) | 12/13
(92.3%) | 13/13
(100%) | 13/13
(100%) | 0/13
(0%) |
Table 3. Overall accuracy for blood glucose concentrations 300 mg/dL) and lower blood glucose range (300 mg/dL.
Medications and Medical Conditions
The subjects in clinical studies can represent the intended use setting. The medical conditions and medications at 9 clinical locations are identified.
During the clinical study, participants received approximately 69 medications representing over 17 parent drug classes and over 17 drug subclasses (with as many as 4 different drugs administered to each patient).
10
According to the medications and medical conditions of subjects from 3 U.S. sites and 6 Taiwan sites, all participants have conditions and are taking medications that are similar to the common patient medications and conditions who needs to measure blood glucose values in the U.S physician offices and endocrinology clinics. The medications and medical conditions of participants in clinical study can represent the indications for use environment.
Usability
A usability was conducted during the clinical study to evaluate the ease of use/understanding of the candidate device. The Owner's Manual, Quick Reference Instructions and Quick Reference Instructions (for Bluetooth pairing) were provided in the clinical study, and operators filled out the questionnaire at the end of study. The results demonstrated that the candidate device is easy to use, and the labeling is easy to understand.
Conclusion
The conclusions drawn from the nonclinical and clinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device. Based on the information provided in this submission, the XPER Technology PREMIUM Pro Blood Glucose Monitoring System has been shown to be substantially equivalent to the predicate device.