(85 days)
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No
The document describes a standard blood glucose monitoring system with a speaking function for accessibility. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on verification and validation against design inputs, not on the performance of an AI/ML algorithm.
No
The device is a blood glucose monitoring system, used to measure glucose levels and aid in monitoring a diabetes control program. It does not provide therapy or treatment.
No
The device is explicitly stated as "not intended for the diagnosis or screening for diabetes mellitus." Its purpose is to monitor glucose levels as "an aid in monitoring the effectiveness of a diabetes control program."
No
The device description explicitly lists hardware components: a blood glucose meter, test strips, control solutions, lancing device, and commercially available lancets.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of glucose in fresh capillary whole blood." This is a classic example of an in vitro test, as it analyzes a biological sample (blood) outside of the body to provide diagnostic information (glucose levels).
- Device Description: The components listed (blood glucose meter, test strips, control solutions) are all typical components of an IVD system used for blood glucose testing.
- Purpose: The purpose is to aid in "monitoring the effectiveness of a diabetes control program," which is a diagnostic purpose related to managing a disease.
While it's not intended for the initial diagnosis or screening of diabetes, its use in monitoring the effectiveness of a control program falls under the scope of IVD devices.
N/A
Intended Use / Indications for Use
The SoloV2TM Blood Glucose Monitoring System, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates.
The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.
This system contains a speaking function that provides audible test results for users with low vision.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA
Device Description
The SoloV2TM Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions, lancing device, and commercially available lancets. The meter has a bilingual speaking feature that provides audible test results for users with low vision. The forearm may be used as an alternate site for capillary blood.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
finger and the forearm
Indicated Patient Age Range
Not intended for use with neonates.
Intended User / Care Setting
healthcare professionals and people with diabetes mellitus at home
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biotest Medical Corp. has conducted a risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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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510(k) Summary (Per 21 CFR 807.92)
Updated on February 18, 2010
MAR - 2 2010
1. Submitter Information
| Company name | Biotest Medical Corporation |
|---|---|
| Contact person | Maggie Chu, President |
| Address | No. 3-2, Chien-Kuo Road, TEPZ, Tantzu |
| Taichung 427, Taiwan | |
| Republic of China | |
| Phone | 886-919099431 |
| Fax | 886-425326593 |
2. Name of Device
| Trade Name | SoloV2TM Blood Glucose Monitoring System |
|---|---|
| Common Name | Blood Glucose Meter |
| Classifications | NBW, Over the Counter Blood Glucose Test, 862.1345 |
| CGA, Glucose Oxidase, 862.1345 | |
| Class II device |
3. Predicate Device
| Trade name | SuperCheck 1 Blood Glucose Monitoring System (SuperCheck 1). |
|---|---|
| Model 6268 | |
| Common name | Blood Glucose Meter |
| Submitter | Biotest Medical Corporation |
| 510(k) number | K091815 |
4. Device Description
The SoloV2TM Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions, lancing device, and commercially available lancets. The meter has a bilingual speaking feature that provides audible test results for users with low vision. The forearm may be used as an alternate site for capillary blood.
5. Intended Use
The SoloV2TM Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates.
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The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.
This system contains a speaking function that provides audible test results for users with low vision.
6. Comparison to Predicate Device
Modifications to the cleared device include additional buttons for volume and language adjustment, additional pre-meal and post-meal Logging Flags, substitution of a USB connection for the previous RS232 cable, addition of an insufficient blood error message, and the removal of the test strip ejector mechanism. The size and shape of the device have also been modified to differentiate from the predicate. The SoloV240 Blood Glucose Monitoring System has the same indented use and fundamental scientific technology as the previous version, the SuperCheck 1 Blood Glucose Monitoring System, Model 6268.
7. Performance Studies
Biotest Medical Corp. has conducted a risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements.
8. Conclusion
In summary, the modified SoloV2TM Blood Glucose Monitoring System has the same intended use and fundamental scientific technology as the previous version of the device, which received 510(k) clearance (K091815). Therefore, the subject device is substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized wing segments.
Biotest Medical Corp. c/o Maggie Chu No.3-2, Chien-Kuo Road, Tepz, Tantzu Taichung, 427 China (Taiwan)
MAR - 2 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Re: K093764
Trade/Device Name: SoloV2™ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: January 26, 2010 Received: February 1, 2010
Dear: Ms. Chu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Signature
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K093764
Device Name: SoloV2TM Blood Glucose Monitoring System
Indications for Use:
The SoloV2TM Blood Glucose Monitoring System, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates.
The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.
This system contains a speaking function that provides audible test results for users with low vision.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use . X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093764
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