(216 days)
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.
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 provided document describes the Sejoy Blood Glucose Monitoring System and Sejoy Advance Link Blood Glucose Monitoring System and their substantial equivalence to a predicate device. Information relevant to acceptance criteria and study proving performance is extracted below.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for blood glucose monitoring systems are primarily based on accuracy compared to a lab reference method. The document specifies accuracy levels at various percentage tolerances.
| Accuracy Tolerance | Acceptance Criterion (Implicit) | Reported Device Performance (Overall) | Reported Device Performance (Glucose <80 mg/dL) | Reported Device Performance (Glucose >250 mg/dL) |
|---|---|---|---|---|
| Within ±5% | N/A (Often implies higher percentages) | 56.8% (200/352) | 54.0% (27/50) | 60.0% (30/50) |
| Within ±10% | N/A (Often implies higher percentages) | 90.3% (318/352) | 92.0% (46/50) | 96.0% (48/50) |
| Within ±15% | N/A (Often implies higher percentages) | 98.3% (346/352) | 100.0% (50/50) | 100.0% (50/50) |
| Within ±20% | N/A (Often implies higher percentages) | 100% (352/352) | 100.0% (50/50) | 100.0% (50/50) |
Note: The document states "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)." This guidance typically sets specific accuracy criteria (e.g., within ±15% for a certain percentage of samples). While the exact numerical criteria from the FDA guidance are not explicitly stated in the provided text, the reported performance metrics clearly indicate the device's adherence to such guidelines, as implied by the phrase "sufficiently accurate."
2. Sample Size Used for the Test Set and Data Provenance
- Overall Test Set Sample Size: 352 lay persons (for the user evaluation study).
- Extreme Glucose Concentrations Test Set Sample Size: 50 subjects for low blood glucose (<80 mg/dL) and 50 subjects for high blood glucose (>250 mg/dL), totaling 100 subjects for this specific sub-study.
- Data Provenance: The document does not explicitly state the country of origin for the data, but it refers to "lay persons representative of the age, gender, education of the intended users in the US," suggesting the study subjects were recruited in the US. The study was a prospective user performance evaluation where subjects self-tested their capillary whole blood.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth was established using a laboratory reference method, the YSI 2300 STAT PLUS glucose analyzer, which is a highly accurate and standardized instrument. There is no mention of experts being used to establish the ground truth for the test set, as the YSI analyzer itself serves as the gold standard.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by a laboratory reference instrument (YSI 2300), not by human readers requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging or interpretation tool. The study involved users operating the device, not interpreting images with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, analytical performance testing was conducted which can be considered analogous to "standalone" performance for such a device. This included:
- Repeatability
- Intermediate precision
- Hematocrit effect
- Short sample volume
- Perturbation
- Interference
- Linearity testing
These tests evaluate the intrinsic performance of the device's measurement algorithm and hardware components, independent of human operation variability.
7. The Type of Ground Truth Used
The ground truth was established using a laboratory reference method: the Yellow Springs Instrument (YSI 2300 STAT PLUS glucose analyzer). The document specifies "capillary plasma" for the YSI 2300 reference, indicating a highly accurate and controlled measurement.
8. The Sample Size for the Training Set
The document describes performance evaluation studies (user evaluation and extreme glucose concentration studies) which are typically "test set" studies for device clearance. It does not provide information on the sample size used for the training set of the device's internal algorithms, as this detail is generally considered proprietary to the manufacturer and not typically included in a 510(k) summary unless the device heavily relies on a continuously learning AI model that requires explicit training data disclosure in the submission. For a blood glucose meter, the "training" (calibration and optimization) of its algorithms is usually done during the device's development phase rather than through a distinct "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Since information about a specific "training set" is not provided, the method for establishing its ground truth is also not detailed. However, for a device like a blood glucose meter, the internal algorithms and calibration are established using highly controlled laboratory experiments and reference methods (like YSI 2300) during the design and development phase to ensure accuracy across the measurement range and various physiological conditions.
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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"
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(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.
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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
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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."
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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."
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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 EconomicDevelopment Zone,Hangzhou City, 311100,Zhejiang, China |
|---|---|
| Correspondent | Yingting Lan, Regulatory Affairs SpecialistPhone:+86-571-81957767E-mail:lanyt@sejoy.com |
| Date Prepared | August 20th, 2024 |
| Device Trade Name | Sejoy Blood Glucose Monitoring SystemSejoy 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
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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)
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- Sejoy Lancing Device and Sejoy Disposable Safety Lancets (K222034)
Comparison to Predicate Device:
| Predicate Device | Subject Devices | ||
|---|---|---|---|
| Specifications andFeatures | OneTouch Verio Reflect Glucose MonitoringSystem (K193475) | Sejoy BloodGlucoseMonitoringSystems | SejoyAdvance LinkBlood GlucoseMonitoringSystems |
| IntendedUse/Indication foruse | It is intended to be used for the quantitativemeasurement of glucose (sugar) in fresh capillarywhole blood samples drawn from the fingertips. Itis intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetesat home as an aid to monitor the effectiveness ofdiabetes control. This system is intended to be usedby a single person and should not be shared. Thesystem should not be used for the diagnosis of, orscreening for diabetes or for neonatal use. | Same | |
| ScientificTechnology | Amperometric detection | Same | |
| Operating Principle | Electrochemical reactionwith GDH-FAD GlucoseDehydrogenase | 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 | |
| GlucoseMeasurement Range | 20 - 600 mg/dL (1.1 - 33.3 mmol/L) | Same | |
| Hematocrit Range | 20-60% | 15-60% | |
| OperatingEnvironment | 6°C-44°C(43°F−111°F) and 10%-90%, noncondensing | 41°F-113°F (5°C-45°C) and10~90% relative humidity | |
| Predicate Device | Subject Devices | ||
| Specifications andFeatures | OneTouch Verio Reflect Glucose MonitoringSystem (K193475) | Sejoy BloodGlucoseMonitoringSystems | SejoyAdvance LinkBlood GlucoseMonitoringSystems |
| Test Strip Storage(Unopened Vial) | 22 months5°C - 30°C (41°F – 86°F)up to 65% RH | 24 months33.8°F | |
| Test Strip Storage(Opened Vial) | 6 months from firstopening | Same | |
| Coding | No calibration code isrequired | Same | |
| Data Download | Via USB or Bluetooth | Bluetooth Low Energy(Sejoy Advance Link only) | |
| Compatible off-metersoftware 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 0.61inches | Approx 3.74 x 2.22 x 0.90inches | |
| Weight | Approx 1.9 ounces | Approx 1.8 ounces | |
| User InterfaceScreen | Menu driven with text andicon based information. | Same |
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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
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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 (<80 mg/dL), and 50 had high 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 <80 mg/dL | |||
|---|---|---|---|
| Within +/- 5% | Within +/- 10% | Within +/- 15% | Within +/- 20% |
| 27/50(54.0%) | 46/50(92.0%) | 50/50(100.0%) | 50/50(100.0%) |
| 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).
§ 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.