(379 days)
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML capabilities. The performance studies focus on system accuracy and user performance, which are typical for this type of device and do not suggest the use of AI/ML.
No.
The device is a diagnostic tool used to measure glucose levels, not directly treat a condition. It aids in monitoring diabetes control, but it does not provide therapy.
Yes
The device is explicitly described as an "in vitro diagnostic use" system, intended for the quantitative measurement of glucose in blood samples. While it is not used for the initial diagnosis of diabetes, it aids in monitoring the effectiveness of diabetes control, which falls under the broader scope of diagnostic devices used for health management.
No
The device description explicitly lists hardware components such as a blood glucose meter, test strips, control solution, lancing device, and sterile lancets. This indicates it is a hardware-based system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Rightest Blood Glucose Monitoring System GM700 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home..."
- Nature of the Test: The device measures glucose in blood samples outside the body, which is the definition of an in vitro diagnostic test.
- Purpose: The purpose is to aid in monitoring the effectiveness of diabetes control, which is a diagnostic purpose.
N/A
Intended Use / Indications for Use
The Rightest Blood Glucose Monitoring System GM700 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole samples drawn from the fingertips, palm and forearm. The Rightest Blood Glucose Monitoring System GM700 is intended to be used by a single person and should not be shared.
The Rightest Blood Glucose Monitoring System GM700 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM700 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The Rightest Blood Glucose Test Strip GS700 is for use with the Rightest Blood Glucose meter GM700 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm.
The Rightest Control Solution GC700 is for use with the Rightest Blood Glucose meter GM700 and Rightest Blood Glucose Test Strips GS700 to check that the meters and test strip are working together properly and that the test is performing correctly.
Product codes
NBW, LFR, JJX
Device Description
Our Rightest Blood Glucose Monitoring System GM700 consists of the following devices: Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strip GS700, Rightest Control Solution GC700, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strips GS700, and Lancing Device are manufactured by BIONIME Corporation. The Rightest Blood Glucose Meter GM700, when used with the Rightest Blood Glucose Test Strips GS700, quantitatively measures glucose in fresh capillary whole blood. The Rightest Blood Glucose Monitoring System GM700 is verified by the Rightest Control Solution GC700.
A Rightest Blood Glucose Monitoring System GM700 kit box may contain different bundled items.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Fingertips, palm, forearm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
People with diabetes at home, for self testing. Single person use.
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
System Accuracy Study: The accuracy study of the Rightest Blood Glucose Monitoring System GM700 was verified by comparing the Rightest Blood Glucose Monitoring System GM700 (plasma equivalent) glucose values on the Rightest meter with plasma glucose values on a lab instrument. A total of 103 patients were participated. The study result demonstrates that the Rightest Blood Glucose Monitoring System GM700 met the acceptance criteria.
User Performance Study: A User performance study was performed to demonstrate that lay consumers could obtain accurate results using the subject device. The study was performed using capillary whole blood from fingertip, palm and forearm sample sites. The study determined the (inaccurate and accurate) position in the Monitoring System GM700 used in finger, palm and forearm position.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
MAR 2 9 2012
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K110737
Submitter's Identification: 1.
BIONIME CORPORRATION NO 694, RENHUA ROAD, DALI DIST., TAICHUNG CITY, TAIWAN 412 Contact Person: __Mr. Roy Huang Phone Number: 886-4-24951268 FAX Number: 886-4-24952568
Date Summary Prepared: March 26, 2011
- Name of the Device: Rightest Blood Glucose Monitoring System GM700 2.
- Common or Usual Name: Glucose test system 3.
| Device Product Code | Device Class | Panel/ Regulation
number |
|--------------------------------------------------------------------|--------------|---------------------------------------|
| NBW; System, Test, Blood
Glucose, Over-the-Counter | Class II | Clinical Chemistry
21 CFR 862.1345 |
| LFR; Glucose Dehydrogenase,
Glucose | Class II | Clinical Chemistry
21 CFR 862.1345 |
| JJX; single(specified) analyte
controls (assayed and unassayed) | Class I | Clinical Chemistry
21 CFR 862.1660 |
Device Description: 4.
Our Rightest Blood Glucose Monitoring System GM700 consists of the following devices: Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strip GS700, Rightest Control Solution GC700, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strips GS700, and Lancing Device are manufactured by BIONIME Corporation. The Rightest Blood Glucose Meter GM700, when used with the Rightest Blood Fightest Dioba Chaoooo motor ontitatively measures glucose in fresh capillary Glucose Test Stinpo Gol oo, Quartest Blood Glucose Monitoring System GM700 is verified by the Rightest Control Solution GC700.
A Rightest Blood Glucose Monitoring System GM700 kit box may contain different bundled items.
1
ട. Intended Use:
The Rightest Blood Glucose Monitoring System GM700 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole for the quantitative mithe fingertips, palm and forearm. The Rightest Blood Samples arawn from them GM700 is intended to be used by a single person and should not be shared.
The Rightest Blood Glucose Monitoring System GM700 is intended for self The Fightest Diood Chood City (in vitro diagnostic use) by people with diabetes at home tes an aid to monitor the effectiveness of diabetes control. The Rightest Blood as an all to monitor nystem GM700 should not be used for the diagnosis of, or Quoose Mornitoring Oyotom ann other or in othernative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The Rightest Blood Glucose Test Strip GS700 is for use with the Rightest Blood Glucose meter GM700 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm.
The Rightest Control Solution GC700 is for use with the Rightest Blood Glucose meter GM700 and Rightest Blood Glucose Test Strip GS700 to check that the meters and test strip are working together properly and that the test is performing correctly.
Predicate Device Information: 6.
The Rightest Blood Glucose Monitoring System Model GM700 is substantially equivalent to the brand of Rightest Blood Glucose Monitoring System noted below.
Rightest Blood Glucose Monitoring System Model GM550 Name: Device Company: Bionime Corporation 510(K) Number: K092052.
Comparison to Predicate Devices: 7. ·
Specification Comparison
| Similarities | ||
|---|---|---|
| Item | Rightest BGMS GM700 | |
| (New Device) | Rightest BGMS GM550 | |
| (Predicate Device K092052) | ||
| Minimum Sample Volume | 1.0 microliter | |
| Test Time | 5 seconds |
2
| Measuring Range | 20-600 mg/dL |
|---|---|
| Operating Relative Humidity | 10 ~ 90% |
| Battery Life | About 1000 tests |
| Monitor | LCD display |
| Meter Storage Conditions | -10 ~ 60°C (14 ~ 140 °F) |
| Test Strip Storage Conditions | 4 ~ 30°C (39 ~ 86 °F), Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Page 1 of 1 |
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety
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