(346 days)
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No
The summary describes a standard blood glucose monitoring system that measures glucose concentration using test strips and a meter. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The performance studies focus on accuracy compared to a lab instrument and user performance, not on the performance of an AI/ML algorithm.
No.
The device is intended for measurement and monitoring of glucose levels, aiding in diabetes management, but it does not directly treat or cure the condition.
No
This device is specifically stated as "not intended for the diagnosis of or screening for diabetes mellitus." While it measures glucose, which is used in diabetes management, it is explicitly not for initial diagnosis.
No
The device description explicitly states that the system consists of a Meter, Blood Glucose Test Strips, Two Control Solutions, Lancing Device, and lancets, indicating it includes hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is for the "quantitative measurement of glucose in capillary whole blood". This is a measurement performed in vitro (outside the body) on a biological sample (blood).
- Device Description: The description details a system that includes a meter, test strips, and control solutions, all designed to analyze a blood sample.
- Performance Studies: The performance studies involve comparing the results obtained from the device using blood samples to a lab instrument, which is a standard method for evaluating IVD performance.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This blood glucose monitoring system fits this definition as it measures glucose in a blood sample to aid in diabetes management (monitoring).
N/A
Intended Use / Indications for Use
The Rightest Blood Glucose Monitoring System, Model GM550 is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel in clinical settings or diabetics at home to measure the glucose concentration for aiding diabetes management.
The glucose concentration is measured with quantitative capillary whole blood from the fingertip, palm, and forearm by using Rightest Blood Glucose Monitoring System, GM550. This device is not intended for testing neonate blood samples and is not intended for the diagnosis of or screening for diabetes mellitus.
Rightest GS550 Blood Glucose Test Strips are intended for use with the Rightest GM550 Blood Glucose meter in the quantitative measurement of glucose in capillary whole blood from the fingertip, palm, and forearm.
Rightest Control Solutions are intended for use with the Rightest GM550 Blood Glucose meter to check that both the glucose meters and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, JJX
Device Description
Our Blood Glucose Monitoring System consists of a Meter, Blood Glucose Test Strips, Two Control Solutions, Lancing Device and lancets. The Rightest Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation. The Rightest Meter, when used with the Rightest Test Strips Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System is verified by the Control Solution.
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
fingertip, palm, forearm
Indicated Patient Age Range
The device is not intended for testing neonate blood samples. Other than this restriction, the age range is not specified.
Intended User / Care Setting
professional healthcare personnel in clinical settings or diabetics 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)
System Accuracy Study:
A total of 114 patients participated. Each patient collected and tested their own blood samples (from the fingertip, palm and forearm) with the Rightest meter. Another blood sample was collected within 5 minutes and got the plasma to be analyzed by the lab instrument (Olympus 2700). Ninety-seven percent of the test results were within ± 20% of the comparison method results at glucose concentrations ≥75 mg/dL and within ±15 mg/dL at glucose concentrations 75 mg/dL):
- Fingertip:
- Within ± 5%: 55.8% (53/95)
- Within ± 10%: 75.8% (72/95)
- Within ± 15%: 91.6% (87/95)
- Within ± 20%: 96.8% (92/95)
- Palm:
- Within ± 5%: 55.8% (53/95)
- Within ± 10%: 75.8% (72/95)
- Within ± 15%: 89.5% (85/95)
- Within ± 20%: 96.8% (92/95)
- Forearm:
- Within ± 5%: 49.5% (47/95)
- Within ± 10%: 71.6% (68/95)
- Within ± 15%: 91.6% (87/95)
- Within ± 20%: 97.9% (93/95)
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.
0
JUN 1 8 2010
Exhibit 1
510(K) SUMMARY
This summary of 5/0(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: K09205 J
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- Submitter's Identification:
BIONIME CORPORRATION NO 694, RENHUA ROAD, DALI CITY, TAICHUNG COUNTY, TAIWAN 412 Contact Person: Mr. George Chi Phone Number: 886-4-24951268 FAX Number: 886-4-24952568
- Submitter's Identification:
Date Summary Prepared: June 01, 2010
2. Name of the Device: Rightest Blood Glucose Monitoring System, Model GM550
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- Common or Usual Name: Glucose test system Panel: Clinical Chemistry 75 Product Code: NBW, System, Test, Blood Glucose, Over-the-Counter. Classification: Class II
Device Description: 4.
Our Blood Glucose Monitoring System consists of a Meter, Blood Glucose Test Strips, Two Control Solutions, Lancing Device and lancets. The Rightest Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation. The Rightest Meter, when used with the Rightest Test Strips Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System is verified by the Control Solution.
- ട. Intended Use:
The Rightest Blood Glucose Monitoring System, Model GM550 is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel in clinical settings or diabetics at home to measure the glucose concentration for aiding diabetes management.
The alucose concentration is measured with quantitative capillary whole blood from the fingertip, palm, and forearm by using Rightest Blood Glucose Monitoring
1
System, GM550. This device is not intended for testing neonate blood samples and is not intended for the diagnosis of or screening for diabetes mellitus.
Rightest GS550 Blood Glucose Test Strips are intended for use with the Rightest GM550 Blood Glucose meter in the quantitative measurement of glucose in capillary whole blood from the fingertip, palm, and forearm.
Rightest Control Solutions are intended for use with the Rightest GM550 Blood Glucose meter to check that both the glucose meters and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
. Predicate Device Information:
The Rightest Blood Glucose Monitoring System GM550 is substantially equivalent to the brand of Rightest Blood Glucose Monitoring System (Alternative Site Testing) noted below.
| Name: | Rightest Blood Glucose Monitoring System |
|---|---|
| Device Company: | Bionime Corporation |
| 510(K) Number: | K042678, K053635 and K062567 |
Comparison to Predicate Devices: 7.
| Specification | Rightest BGMS GM550 | Rightest BGMS GM300 |
|---|---|---|
| (New Device) | (Predicate Device-K062567) | |
| Interference | Uric acid $\geq$ 10 mg/dL | Uric acid > 9.0 mg/dL |
| Memory Capacity | 500 blood glucose test results | |
| with date and time | 300 blood glucose test results with | |
| date and time | ||
| Power Supply | Two CR2032 batteries | Two 1.5V (AAA) batteries |
| Power Saving | Turn off automatically 2 minutes | |
| after last user action / Press the | ||
| main button for 4 seconds. | Turn off automatically after 3 | |
| minutes no use | ||
| Meter Dimension | 90.6 mm × 46 mm × 16.5 mm | 85.0 mm × 58.0 mm × 22.0 mm |
| Meter Weight | 53.0 ± 5 g with batteries | 85.0 g with batteries |
| Coding | Auto coding | Code key |
| Minimum Sample Volume | 1.0 microliter | 1.4 microliter |
| Test Time | 5 seconds | 8 seconds |
| Hematocrit Range | 30 - 60% | 30 - 55% |
| LCD display area | 47 mm × 33.5 mm | 39.0 mm × 38.0 mm |
| Strip Reagent | 1.Glucose Oxidase (GOD) 14.8% | |
| 2.Potassium ferricyanide 39.5% | ||
| 3.Non-reactive ingredients 45.7% | 1.Glucose Oxidase (GOD) 8.5% | |
| 2.Potassium ferricyanide 48.5% | ||
| 3.Non-reactive ingredients 43% | ||
| Control Solution Reagent | ||
| (Normal level) | 1.Water 84% | |
| 2.d-Glucose 0.1% | ||
| 3.Viscosity enhancing agent 15% | ||
| 4.Inorganic salts / Buffers 1.0% | ||
| 5.Dye 0.08% | ||
| 6.Preservative 0.03% | 1.Water 83% | |
| 2.d-Glucose 0.1% | ||
| 3.Viscosity enhancing agent 15% | ||
| 4.Inorganic salts / Buffers 1.4% | ||
| 5.Dye 0.005% | ||
| 6.Preservative 0.03% | ||
| Control Solution Reagent | ||
| (High level) | 1.Water 69% | |
| 2.d-Glucose 0.3% | ||
| 3.Viscosity enhancing agent 29.5% | ||
| 4.Inorganic salts / Buffers 1.0% | ||
| 5.Dye 0.08% | ||
| 6.Preservative 0.03% | 1.Water 83% | |
| 2.d-Glucose 0.3% | ||
| 3.Viscosity enhancing agent 15% | ||
| 4.Inorganic salts / Buffers 1.4% | ||
| 5.Dye 0.005% | ||
| 6.Preservative 0.03% | ||
| Measurement Technology | Oxidase Electrochemical Sensor | |
| Sample | Capillary whole blood | |
| Measuring Range | 20-600 mg/dL | |
| Operating Tempature | ||
| Range | 10 ~ 40°C (50 ~ 104 °F) | |
| Operating Relative Humidity | ||
| Range | 10 ~ 90% | |
| Battery Life | About 1000 tests | |
| Meter Storage Conditions | -10 ~ 60°C (14 ~ 140 °F) | |
| Test Strip Storage | ||
| Conditions | 4 ~ 30°C (39 ~ 86 °F), |