(193 days)
No
The description focuses on the electrochemical reaction for glucose measurement and standard software validation, with no mention of AI or ML.
No
This device is for quantitative measurement of glucose for monitoring purposes, and explicitly states it is "not intended for the diagnosis of, or screening for diabetes." Therefore, it is not a therapeutic device.
Yes
The document explicitly states, "It is for in vitro diagnostic use only." and describes its function as measuring glucose to aid in monitoring diabetes control, which are characteristics of a diagnostic device. While it states it's "not intended for the diagnosis of, or screening for diabetes," its role in monitoring an existing condition falls under the broader definition of diagnostics.
No
The device description explicitly states that the system is comprised of a blood glucose meter (hardware) and test strips (hardware/consumable), in addition to mentioning software validation studies. This indicates it is a hardware-based medical device with accompanying software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "It is for in vitro diagnostic use only."
- Method of Measurement: The "Device Description" explains that the device measures glucose in a blood sample outside of the body using a chemical reaction on a test strip. This is the definition of an in vitro diagnostic test.
- Purpose: The device is intended to aid in monitoring diabetes control, which is a diagnostic purpose performed on a sample taken from the patient.
N/A
Intended Use / Indications for Use
The TRUENESS™ AIR Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of their diabetes control program. The TRUENESS™ AIR Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is for in vitro diagnostic use only. The TRUENESS™ AIR Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for diabetes. It is not intended for use on neonates.
The TRUENESS™ AIR Blood Glucose Monitoring System is comprised of the TRUENESS™ AIR blood glucose meter and the TRUENESS™ blood glucose test strip.
The TRUENESS™ Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of their diabetes control program. The TRUENESS™ Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is for in vitro diagnostic use only. The TRUENESS™ Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for diabetes. It is not intended for use on neonates.
The TRUENESS™ Blood Glucose Monitoring System is comprised of the TRUENESS™ blood glucose meter and the TRUENESS™ blood glucose test strip.
Product codes
NBW
Device Description
The TRUENESS Blood Glucose Monitoring System and TRUENESS AIR Blood Glucose Monitoring System mainly consist of two parts as below:
(1) TRUENESS Blood Glucose Meter or TRUENESS AIR Blood Glucose Meter (With Bluetooth function)
(2) TRUENESS Blood Glucose Test Strip
A glucose test is based on measurement of electrical current caused by the reaction of glucose with flavin adenine dinucleotide (FAD) glucose dehydrogenase on the electrode of the test strip. The blood or control solution sample is drawn into the tip of the TRUENESS Blood Glucose Test Strip through capillary action. Glucose in the sample reacts with the FAD glucose dehydrogenase and generate electrons. The magnitude of the resultant current is proportional to the concentration of glucose in the blood and is converted to a glucose concentration. The glucose concentration is displayed on the meter display for the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
people with diabetes mellitus at home, a single person
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 user evaluation confirmed the system accuracy, operation according to design, and ease of use to support the intended use as described in the proposed labeling.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification and validation testing consisted of performance tests (precision, linearity, interference, flex studies), electrical/mechanical safety tests, as well as disinfection, cleaning, and robustness studies. Software validation studies were performed for moderate level of concern device per FDA Guidance Content of Premarket Submissions for Software Contained in Medical Devices. Results from these studies show that the subject device met design specifications and requirements.
A user evaluation confirmed the system accuracy, operation according to design, and ease of use to support the intended use as described in the proposed labeling.
The conclusions from the nonclinical and clinical tests demonstrated that the device is as safe, as effective, and performs as well as legally marketed device identified above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 1, 2023
Sinocare Inc. Lingjia Zhu Regulatory Affairs Engineer No.265 Guyuan Road, Hi-Tech Zone, Changsha, Hunan Province Changsha, Hunan 410205 China
Re: K231476
Trade/Device Name: TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: May 22, 2023 Received: May 22, 2023
Dear Lingjia Zhu:
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" (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).
1
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 (OS) 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.
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.
For comprehensive regulatory information about mediation-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
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Indications for Use
510(k) Number (if known) K231476
Device Name
TRUENESS™ AIR Blood Glucose Monitoring System
Indications for Use (Describe)
The TRUENESS™ AIR Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of their diabetes control program. The TRUENESS™ AIR Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is for in vitro diagnostic use only. The TRUENESS™ AIR Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for diabetes. It is not intended for use on neonates.
The TRUENESS™ AIR Blood Glucose Monitoring System is comprised of the TRUENESS™ AIR blood glucose meter and the TRUENESS™ blood glucose test strip.
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."
3
Indications for Use
510(k) Number (if known) K231476
Device Name
TRUENESS™ Blood Glucose Monitoring System
Indications for Use (Describe)
The TRUENESS™ Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of their diabetes control program. The TRUENESS™ Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is for in vitro diagnostic use only. The TRUENESS™ Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for diabetes. It is not intended for use on neonates.
The TRUENESS™ Blood Glucose Monitoring System is comprised of the TRUENESS™ blood glucose meter and the TRUENESS™ blood glucose test strip.
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
510(k) Summary
1. Contact details
| 510(k) Number: | K231476 |
|---|---|
| Applicant Name: | Sinocare Inc. |
| Applicant Name: | No.265 Guyuan Road, Hi-tech Zone, Changsha, |
| Hunan Province, 410205, China. | |
| Applicant Contact Telephone: | +86-18890033693 |
| Applicant Contact: | Candy.zhou@sinocare.com |
| Correspondent Name: | Sinocare Inc. |
| Correspondent Address: | No.265 Guyuan Road, Hi-tech Zone, Changsha, |
| Hunan Province, 410205, China. | |
| Correspondent Contact Telephone: | +86-15573694818 |
| Correspondent Contact: | Lingjia Zhu |
| Correspondent Contact email: | lingjia.zhu@sinocare.com |
| Applicant Contact email: | Candy.zhou@sinocare.com |
| Prepared on: | 11/28/2023 |
-
- Device Name
| Trade Name: | TRUENESSTM AIR Blood Glucose Monitoring
System;
TRUENESSTM Blood Glucose Monitoring |
|----------------------|-------------------------------------------------------------------------------------------|
| Common Name: | System Blood Glucose Monitoring System |
| Classification Name: | System, Test, Blood Glucose, Over The Counter |
| Regulation Number: | 862.1345 |
| Product Code: | NBW |
3. Legally Marketed Predicate Devices
Contour® next GEN Blood Glucose Monitoring System (K193407)
Product Code:
Page (1) of Page (4)
NBW
5
4. Device Description Summary
A Device description
The TRUENESS Blood Glucose Monitoring System and TRUENESS AIR Blood Glucose Monitoring System mainly consist of two parts as below:
- (1) TRUENESS Blood Glucose Meter or TRUENESS AIR Blood Glucose Meter (With Bluetooth function)
- (2) TRUENESS Blood Glucose Test Strip
B Principle of Operation
A glucose test is based on measurement of electrical current caused by the reaction of glucose with flavin adenine dinucleotide (FAD) glucose dehydrogenase on the electrode of the test strip. The blood or control solution sample is drawn into the tip of the TRUENESS Blood Glucose Test Strip through capillary action. Glucose in the sample reacts with the FAD glucose dehydrogenase and generate electrons. The magnitude of the resultant current is proportional to the concentration of glucose in the blood and is converted to a glucose concentration. The glucose concentration is displayed on the meter display for the user.
5. Intended Use/Indications For Use
The TRUENESS™ Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of their diabetes control program. The TRUENESS™ Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is for in vitro diagnostic use only. The TRUENESS™ Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for diabetes. It is not intended for use on neonates.
The TRUENESS™ Blood Glucose Monitoring System is comprised of the TRUENESS™ blood glucose meter and the TRUENESS™ blood glucose test strip.
The TRUENESS™AIR Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of their diabetes control program. The TRUENESS™AIR Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is for in vitro diagnostic use only. The TRUENESS™AIR Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for diabetes. It is not intended for use on neonates.
The TRUENESS™ AIR Blood Glucose Monitoring System is comprised of the TRUENESS™ AIR blood glucose meter and the TRUENESS™ blood glucose test strip.
6
6. Indications for Use Comparison
The indications for use of the TRUENESS Blood Glucose Monitoring System/TRUENESS AIR Blood Glucose Monitoring System and predicate device are the same.
7. Technological Comparison
| Predicate device | Subject Devices | ||
|---|---|---|---|
| Features | Contour® next GEN | ||
| (K193407) | TRUENESS | TRUENESS | |
| AIR | |||
| (with Bluetooth) | |||
| Specimen Type | Capillary whole blood | Capillary whole blood | Capillary whole blood |
| Where Device Used | Home | Home | Home |
| Reagent Form | Electrochemical Test | ||
| Strip | Electrochemical Test Strip | Electrochemical Test Strip | |
| Methodology | Electrochemical | ||
| Biosensor | Electrochemical Biosensor | Electrochemical Biosensor | |
| Storage Environment | 41°F -86°F | 41°F -86°F | 41°F -86°F |
| Test Time | 5 seconds | 5 seconds | 5 seconds |
| Units of Measure | mg/dL | mg/dL | mg/dL |
| Reagent Enzyme | FAD- Glucose | ||
| Dehydrogenase | FAD- Glucose Dehydrogenase | FAD- Glucose Dehydrogenase | |
| Averages Calculation | 7/14/30/90-day averages | 7/14/30/90-day averages | 7/14/30/90-day averages |
| Test strip calibration | No coding | No coding | No coding |
| BLE Pairing | Yes | Yes (TRUENESS AIR only) | Yes (TRUENESS AIR only) |
| Wireless | |||
| Communication | Bluetooth Low Energy | Bluetooth Low Energy | |
| (TRUENESS AIR only) | Bluetooth Low Energy | ||
| (TRUENESS AIR only) | |||
| Operating | |||
| Environment | 41°F-113°F (5°C-45°C) | 50°F-104°F (10°C-40°C) | 50°F-104°F (10°C-40°C) |
| Hematocrit Range | 20%-55% | 15%-60% | 15%-60% |
| Test Results | Plasma/serum glucose | ||
| calibrated | Plasma glucose calibrated | Plasma glucose calibrated | |
| Measurement Range | 20 – 600 mg/dL | 40 - 600 mg/dL | 40 - 600 mg/dL |
7
| Power Source | Two 3-volt CR2032 or
DL2032 coin cell
batteries | 2 AAA alkaline batteries |
|--------------|-------------------------------------------------------|--------------------------|
| Sample Size | 0.6μL | 1 µL |
| Altitude | Up to 20,674 ft | Up to 10,100 ft |
8. Non-Clinical and/or Clinical Tests Summary & Conclusions
Design verification and validation testing consisted of performance tests (precision, linearity, interference, flex studies), electrical/mechanical safety tests, as well as disinfection, cleaning, and robustness studies. Software validation studies were performed for moderate level of concern device per FDA Guidance Content of Premarket Submissions for Software Contained in Medical Devices. Results from these studies show that the subject device met design specifications and requirements.
A user evaluation confirmed the system accuracy, operation according to design, and ease of use to support the intended use as described in the proposed labeling.
The conclusions from the nonclinical and clinical tests demonstrated that the device is as safe, as effective, and performs as well as legally marketed device identified above.