(216 days)
Not Found
No
The description focuses on standard electrochemical measurement technology and software for converting current to glucose values. There is no mention of AI/ML in the device description, intended use, or performance studies.
No
The device is an in-vitro diagnostic system used to measure glucose levels for monitoring diabetes control; it does not provide therapy.
No
The "Intended Use / Indications for Use" explicitly states: "The system should not be used for the diagnosis of, or screening for diabetes or for neonatal use." This indicates it is not a diagnostic device.
No
The device is described as a "Blood Glucose Monitoring System" composed of a "Blood Glucose Meter" and "Blood Glucose Test Strips". While it mentions "system software" that converts electrical current to values, the core functionality relies on physical hardware (meter) and consumables (test strips) that interact with a biological sample. The description clearly indicates a hardware-based system with integrated software, not a standalone software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use statement explicitly states: "The Sejoy Blood Glucose Monitoring System is intended for self-testing outside the body (in-vitro diagnostic use)..." and "The Sejoy Advance Link Blood Glucose Monitoring System is intended for self-testing outside the body (in-vitro diagnostic use)...".
This clearly indicates that the device is designed to be used on samples taken from the human body (blood) to provide information about a physiological state (blood glucose levels) outside of the body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sejoy Blood Glucose Monitoring System is composed of the Sejoy Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood collected from the fingertip. The Sejoy Blood Glucose Monitoring System is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The system should not be used for the diagnosis of, or screening for diabetes or for neonatal use.
The Sejoy Advance Link Blood Glucose Monitoring System is composed of the Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Advance Link Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Sejoy Advance Link Blood Glucose Monitoring System is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The system should not be used for the diagnosis of, or screening for diabetes or for neonatal use.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
The Sejoy Advance Link Blood Glucose Monitoring System is composed of the Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Test Strips, and the Sejoy Blood Glucose Monitoring System is composed of the Sejoy Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Blood Glucose Control Solutions, and the Sejoy Lancing Device with Sejoy disposable safety lancets (K222034, manufactured independently by Beijing Ruicheng Medical Supplies Co. Ltd. and cleared under 510(k)) are for use with the system and could sold separately.
The Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Meter differ only in Bluetooth functionality which is present only in the Sejoy Advance Link Blood Glucose Meter.
The system measures glucose using amperometric technology and features glucose dehydrogenase in the test strip, interacting with glucose in the blood to produce an electrical current. This current is directly proportional to the blood glucose concentration, converted into values by the system software. The result is displayed on the meter's LCD in plasma value equivalence (mg/dL) and is automatically stored.
The following items are included with the system, and are also sold separately:
- Sejoy Blood Glucose Control Solutions (CTRL1, CTRL2, and CTRL3)
- Sejoy Lancing Device and Sejoy Disposable Safety Lancets (K222034)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Individuals with diabetes at home (self-testing)
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
User evaluation Comparison Study:
Sample Size: 352 lay persons
Data Source: Capillary whole blood drawn by lay persons. The comparator method was the YSI 2300 STAT PLUS glucose analyzer using capillary plasma.
Annotation Protocol: Not specified, but the study compared results from the Sejoy Advance Link Blood Glucose Monitoring System with the YSI 2300 STAT PLUS glucose analyzer.
Accuracy at extreme glucose concentrations:
Sample Size: 50 subjects for low blood glucose (250 mg/dL).
Data Source: Unaltered capillary blood specimens. The comparator method was the YSI 2300.
Annotation Protocol: All samples were tested with the Sejoy Advance Link Blood Glucose Monitoring System using 3 test strip lots and compared to the results obtained on the comparator method (YSI 2300).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Analytical Performance Testing and User Performance Evaluation (Clinical Study)
Analytical Performance Testing:
Study Type: Bench testing
Sample Size: Not specified
Key Results: Repeatability, intermediate precision, hematocrit effect, short sample volume, perturbation, interference, and linearity testing were conducted. The devices performed similarly to the predicate device and the YSI 2300 glucose analyzer.
User Evaluation Comparison Study:
Study Type: Clinical (user evaluation) study.
Sample Size: 352 lay persons.
Key Results: Intended lay persons were able to obtain sufficiently accurate blood glucose readings when using the Sejoy Advance Link Blood Glucose Monitoring System compared to the laboratory-based comparator method (YSI 2300 STAT PLUS glucose analyzer). Users demonstrated satisfaction with ease of operation and overall performance.
Accuracy Metrics:
- Within ±5%: 200/352 = 56.8%
- Within ±10%: 318/352 = 90.3%
- Within ±15%: 346/352 = 98.3%
- Within ±20%: 352/352 = 100%
Accuracy at extreme glucose concentrations:
Study Type: Testing with contrived capillary blood specimens.
Sample Size: 50 subjects for glucose concentrations 250 mg/dL.
Key Results:
- For glucose concentrations 250 mg/dL:
- Within +/- 5%: 30/50 (60.0%)
- Within +/- 10%: 48/50 (96.0%)
- Within +/- 15%: 50/50 (100.0%)
- Within +/- 20%: 50/50 (100.0%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- User Evaluation Comparison Study (Accuracy vs. YSI 2300):
- Within ±5%: 56.8%
- Within ±10%: 90.3%
- Within ±15%: 98.3%
- Within ±20%: 100%
- Accuracy at extreme glucose concentrations (vs. YSI 2300):
- Glucose concentrations 250 mg/dL:
- Within +/- 5%: 60.0%
- Within +/- 10%: 96.0%
- Within +/- 15%: 100.0%
- Within +/- 20%: 100.0%
- Glucose concentrations 250 mg/dL:
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.
OneTouch Verio Reflect Glucose Monitoring System (K193475)
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.
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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 8, 2024
Sejoy Biomedical Co., Ltd Yinting Lan Regulatory Affairs Specialist Area C, Building 2, No.365 Wuzhou Road Yuhang Economic Development Zone Hangzhou City, Zhejiang 311100 China
Re: K240640
Trade/Device Name: Sejoy Blood Glucose Monitoring System and Sejoy Advance Link Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: September 6, 2024 Received: September 6, 2024
Dear Yinting Lan:
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) K240640
Device Name
Sejoy Advance Link Blood Glucose Monitoring System
Indications for Use (Describe)
The Sejoy Advance Link Blood Glucose Monitoring System is composed of the Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Advance Link Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Sejoy Advance Link Blood Glucose Monitoring System is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The system should not be used for the diagnosis of, or screening for diabetes or for neonatal use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X 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
Indications for Use
510(k) Number (if known) K240640
Device Name Sejoy Blood Glucose Monitoring System
Indications for Use (Describe)
The Sejoy Blood Glucose Monitoring System is composed of the Sejoy Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood collected from the fingertip. The Sejoy Blood Glucose Monitoring System is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an and to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The system should not be used for the diagnosis of, or screening for diabetes or for neonatal use.
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
| ☐ Residential Use (Part 21 CFR 801 Subpart D)☒ Over-The-Counter Use (21 CFR 801 Subpart G) | ☐ Residential Use (Part 21 CFR 801 Subpart D) | ☒ Over-The-Counter Use (21 CFR 801 Subpart G) | |
| ☐ Residential Use (Part 21 CFR 801 Subpart D) | ☒ Over-The-Counter Use (21 CFR 801 Subpart G) |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X 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."
5
Traditional 510(k)
510(k) Summary
The assigned 510(k) number is K240640
| Sponsor | SEJOY Biomedical Co., Ltd.
Area C, Building 2, No.365 Wuzhou Road,Yuhang Economic
Development Zone,Hangzhou City, 311100,Zhejiang, China |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent | Yingting Lan, Regulatory Affairs Specialist
Phone:+86-571-81957767
E-mail:lanyt@sejoy.com |
| Date Prepared | August 20th, 2024 |
| Device Trade Name | Sejoy Blood Glucose Monitoring System
Sejoy Advance Link Blood Glucose Monitoring System |
| Common Name | Glucose Test System |
| Classification | Class II device (21 CFR § 862.1345),
Product Code NBW |
| Predicate Device | OneTouch Verio Reflect Glucose Monitoring System (K193475)
Product Code NBW |
Intended Use/Indications For Use
The Sejoy Blood Glucose Monitoring System is composed of the Sejoy Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood collected from the fingertip. The Sejoy Blood Glucose Monitoring System is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single
6
person and should not be shared. The system should not be used for the diagnosis of, or screening for diabetes or for neonatal use.
The Sejoy Advance Link Blood Glucose Monitoring System is composed of the Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Advance Link Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Sejoy Advance Link Blood Glucose Monitoring System is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The system should not be used for the diagnosis of, or screening for diabetes or for neonatal use.
Device Description Summary
The Sejoy Advance Link Blood Glucose Monitoring System is composed of the Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Test Strips, and the Sejoy Blood Glucose Monitoring System is composed of the Sejoy Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Blood Glucose Control Solutions, and the Sejoy Lancing Device with Sejoy disposable safety lancets (K222034, manufactured independently by Beijing Ruicheng Medical Supplies Co. Ltd. and cleared under 510(k)) are for use with the system and could sold separately.
The Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Meter differ only in Bluetooth functionality which is present only in the Sejoy Advance Link Blood Glucose Meter.
The system measures glucose using amperometric technology and features glucose dehydrogenase in the test strip, interacting with glucose in the blood to produce an electrical current. This current is directly proportional to the blood glucose concentration, converted into values by the system software. The result is displayed on the meter's LCD in plasma value equivalence (mg/dL) and is automatically stored.
The following items are included with the system, and are also sold separately:
- · Sejoy Blood Glucose Control Solutions (CTRL1, CTRL2, and CTRL3)
7
- Sejoy Lancing Device and Sejoy Disposable Safety Lancets (K222034)
Comparison to Predicate Device:
| Predicate Device | Subject Devices | ||
|---|---|---|---|
| Specifications and | |||
| Features | OneTouch Verio Reflect Glucose Monitoring | ||
| System (K193475) | Sejoy Blood | ||
| Glucose | |||
| Monitoring | |||
| Systems | Sejoy | ||
| Advance Link | |||
| Blood Glucose | |||
| Monitoring | |||
| Systems | |||
| Intended | |||
| Use/Indication for | |||
| use | It is intended to be used for the quantitative | ||
| measurement of glucose (sugar) in fresh capillary | |||
| whole blood samples drawn from the fingertips. It | |||
| is intended for self-testing outside the body (in- | |||
| vitro diagnostic use), by individuals with diabetes | |||
| at home as an aid to monitor the effectiveness of | |||
| diabetes control. This system is intended to be used | |||
| by a single person and should not be shared. The | |||
| system should not be used for the diagnosis of, or | |||
| screening for diabetes or for neonatal use. | Same | ||
| Scientific | |||
| Technology | Amperometric detection | Same | |
| Operating Principle | Electrochemical reaction | ||
| with GDH-FAD Glucose | |||
| Dehydrogenase | Same | ||
| Calibration | Plasma-equivalent | Same | |
| Sample Site | Fingertip only | Same | |
| Sample Type | Capillary | Same | |
| Sample Volume | Minimum 0.4 ul | Minimum 0.6 ul | |
| Test Time | 5 seconds | Same | |
| Glucose | |||
| Measurement Range | 20 - 600 mg/dL (1.1 - 33.3 mmol/L) | Same | |
| Hematocrit Range | 20-60% | 15-60% | |
| Operating | |||
| Environment | 6°C-44°C(43°F−111°F) and 10%-90%, non | ||
| condensing | 41°F-113°F (5°C-45°C) and | ||
| 10~90% relative humidity | |||
| Predicate Device | Subject Devices | ||
| Specifications and | |||
| Features | OneTouch Verio Reflect Glucose Monitoring | ||
| System (K193475) | Sejoy Blood | ||
| Glucose | |||
| Monitoring | |||
| Systems | Sejoy | ||
| Advance Link | |||
| Blood Glucose | |||
| Monitoring | |||
| Systems | |||
| Test Strip Storage | |||
| (Unopened Vial) | 22 months | ||
| 5°C - 30°C (41°F – 86°F) | |||
| up to 65% RH | 24 months | ||
| 33.8°F | |||
| 10~90% relative humidity | |||
| Test Strip Storage | |||
| (Opened Vial) | 6 months from first | ||
| opening | Same | ||
| Coding | No calibration code is | ||
| required | Same | ||
| Data Download | Via USB or Bluetooth | Bluetooth Low Energy | |
| (Sejoy Advance Link only) | |||
| Compatible off- | |||
| meter | |||
| software accessories | OneTouch Reveal | None | |
| Power source | 2 x 3V CR2032 | 2 x AAA | |
| Meter Size | |||
| (L x W x H) | Approx 3.97 x 1.69 x 0.61 | ||
| inches | Approx 3.74 x 2.22 x 0.90 | ||
| inches | |||
| Weight | Approx 1.9 ounces | Approx 1.8 ounces | |
| User Interface | |||
| Screen | Menu driven with text and | ||
| icon based information. | Same |
8
Summary of Performance Characteristics
Sejoy Blood Glucose Monitoring System and Sejoy Advance Link Blood Glucose Monitoring System were designed and tested in accordance with FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (September 2020). Analytical performance testing included repeatability, intermediate precision, hematocrit effect, short sample volume, perturbation, interference, and linearity testing. A user performance evaluation was also conducted in accordance with FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (September 2020; Section VI.C) which assessed the accuracy of results
9
and usability of the device in the hands of intended users. SEJOY Blood Glucose Monitoring System and Sejoy Advance Link Blood Glucose Monitoring System performed similarly to both the predicate device as well as to a laboratory reference method, the Yellow Springs Instrument (YSI 2300 glucose analyzer).
User evaluation Comparison Study
A clinical (user evaluation) study was conducted with Sejoy Advance Link Blood Glucose Monitoring System. The Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Meter differ only in Bluetooth functionality, and therefore this study also supports the accuracy of the Sejoy Blood Glucose Meter.The study comprised evaluating the system accuracy of the Sejoy Advance Link Blood Glucose Monitoring System by 352 lay persons representative of the age, gender, education of the intended users in the US that self-tested their capillary whole blood and compared to the YSI 2300 STAT PLUS glucose analyzer using capillary plasma. Study results indicated that intended lay persons were able to obtain sufficiently accurate blood glucose readings when using the Sejoy Advance Link Blood Glucose Monitoring System compared to the laboratory-based comparator method. 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 Guide and the overall performance of the Sejoy Advance Link Blood Glucose Monitoring System. Users were able to achieve the following level of accuracy compared to the laboratory method:
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
|---|---|---|---|
| n (%) | n (%) | n (%) | n (%) |
| $200/352 = 56.8%$ | $318/352 = 90.3%$ | $346/352 = 98.3%$ | $352/352 = 100%$ |
Accuracy at extreme glucose concentrations
A study was conducted to assess the accuracy of Sejoy Advance Link Blood Glucose Monitoring System at extremely low and high glucose levels using contrived capillary blood specimens. Among them, 50 subjects had low blood glucose (250 mg/dL). All blood glucose samples were unaltered. All samples were tested with the Sejoy Advance Link Blood Glucose Monitoring System using 3 test strips lots and compared to the results obtained on the comparator method (YSI 2300). Results are summarized below:
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| Sejoy Advance Link Blood Glucose Monitoring System for glucose concentrations 250 mg/dL | | | |
| Within +/- 5% | Within +/- 10% | Within +/- 15% | Within +/- 20% |
| 30/50(60.0%) | 48/50(96.0%) | 50/50(100.0%) | 50/50(100.0%) |
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence
Design verification and validation testing confirmed that the performance, safety, and effectiveness of the Sejoy Blood Glucose Monitoring Systemand and Sejoy Advance Link Blood Glucose Monitoring System were met against all design input specifications and the system can be considered substantially equivalent to that of the predicate device. Evaluations included repeatability, intermediate precision, and linearity. Sejoy Blood Glucose Monitoring System and Sejoy Advance Link Blood Glucose Monitoring System also meets the recommendations of FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (September 2020), and applicable recognized electrical and safety standards including FCC requirements.
Conclusions
The proposed device is substantially equivalent in its intended use, performance, safety, effectiveness and underlying scientific and operating principles to the predicate, The OneTouch Verio Reflect Blood Glucose Monitoring System (K193475).