(189 days)
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No
The device description and performance studies focus on electrochemical measurement and standard analytical performance metrics, with no mention of AI or ML.
No
A therapeutic device is used to treat or cure a disease or condition. This device is an in vitro diagnostic device used to measure blood glucose levels, which is for monitoring and not for treatment.
Yes
The device is intended for the quantitative measurement of glucose, which is used as an aid to monitor the effectiveness of diabetes control. This measurement provides information that helps in managing the condition, falling under the definition of a diagnostic device, even though it's specified not for diagnosis or screening of diabetes.
No
The device description explicitly states that the system consists of a blood glucose meter (hardware), test strips (hardware/consumable), and control solution (consumable). The core function of measuring glucose relies on the interaction between the meter and the test strip, which are physical components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The "Intended Use / Indications for Use" section explicitly states: "The GE Blood Glucose Monitoring System 333 is intended for self testing outside the body (in vitro diagnostic use)..."
- Nature of the Test: The device measures glucose in a biological sample (blood) outside the body. This is the core characteristic of an in vitro diagnostic device.
- Device Description: The description details how the device interacts with a blood sample and a test strip to perform a measurement.
The information provided clearly indicates that the GE Blood Glucose Monitoring System 333 is designed to perform a diagnostic test on a sample taken from the human body, but performed outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GE Blood Glucose Monitoring System 333 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE Blood Glucose Monitoring System 333 is intended to be used by a single person and should not be shared.
The GE Blood Glucose Monitoring System 333 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 GE Blood Glucose Monitoring System 333 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 GE Blood Glucose Test Strips 333 are for use with the GE Blood Glucose Meter 333 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA
Device Description
The GE Blood Glucose Monitoring System 333 consists of the following devices: GE Blood Glucose Meter 333, GE Blood Glucose Test Strip 333, and Rightest Control Solution GC550. The GE333 Blood Glucose Meter and GE Blood Glucose Test Strips 333 are manufactured by BIONIME Corporation. The GE Blood Glucose Meter 333, when used with the GE Blood Glucose Test Strips 333, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE Blood Glucose Monitoring System 333 is verified by the Rightest Control Solution GC550.
The Rightest Control Solution GC550 has been previously been cleared (K092052) and is being repackage for use with the GE Blood Glucose Monitoring System 333.
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
fingertips, forearm, palm
Indicated Patient Age Range
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Intended User / Care Setting
self testing outside the body (in vitro diagnostic use) by people with diabetes 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)
Linearity
The linearity study evaluated detection range using 3 lots of blood glucose test strips. Venous blood samples spiked to 15 levels of glucose concentrations were used, ranging from low to high level (0 to 604 mg/dL), and evaluated compared to reference method YSI 2300 analyzer.
The tested glucose concentration ranged from 0 to 604 mg/dL. Analysis of results indicated linear regression between device and reference method shows mean slopes above 0.9912 and R2 values above 0.999. The results support the claim that glucose assay is linear from 20-600 mg/dL - identical to prior 510k cleared claims.
Precision
Based on the requirements, the precision study evaluated repeatability - conducted over 10 days at 5 glucose concentrations, and intermediate precision - conducted over 10 days at 3 glucose concentrations. 10 meters (3 models), 3 lots of test strips were used; 1500 test strips were used for repeatability evaluation and 900 test strips were used for intermediate precision evaluation. The venous blood sample results were compared against reference method YSI 2300 Analyzer.
The repeatability evaluation and intermediate precision evaluation results demonstrate that repeatability and intermediate precision falls within the acceptance criteria.
Sample Volume
The sample volume study evaluated sample volume using 3 lots of blood glucose test strips. Venous blood at 3 glucose concentration levels and at 9 sample volumes (ranging from 0.60 to 3.0 µL) was used.
The sample volume study results demonstrate that when sample volumes were less than 0.60uL. meter displayed error message (Er4). At all other sample volumes (greater than 0.65 µL), the results were within the accepted criteria of ±10% bias compared to reference. Thus, the minimum sample volume is 0.75 µL.
Interference Study
Based on the requirements and standards of CLSI: EP7-A2, the interference study evaluated interference substances using 3 lots of test strips at 2 glucose concentration levels of venous blood samples, and 19 interference substances.
According to study results, ascorbic acid (≥ 5 mg/dL), cholesterol (600 mg/dL), and uric acid (≥ 10 mg/dL) indicate percentage of interference over ±10% bias in high glucose concentration. This may lead to inaccurate test results, and is stated in the limitations section of the test strip package insert. The remaining 16 interference substances are within the criteria for normal and high glucose concentrations.
Hematocrit Study
The Hematocrit Study evaluated hematocrit levels using 3 lots of blood glucose test strips (HCT range 20-60%) at 6 glucose concentration levels of venous blood samples, tested in 5 replicates. The results were compared against reference method YSI 2300 Analyzer.
The obtained study results indicate that the stability compared to the reference method during various HCT ranges were all within the criteria of ±15% of reference value. The acceptable HCT range is 20-60%.
System Accuracy Study
System accuracy and precision was evaluated to 1) determine if subject device meets criteria and EGA, and 2) asses clinical performance of measuring glucose in capillary whole blood obtained from fingertip, palm, and/or forearm. The study was performed by comparing blood glucose values measured on subject device with values measured on comparative meter (Roche ACCU-CHEK Performa), with YSI 2300 Plus Glucose Analyzer used as a reference.
A total of 103 patients were participated. The study result demonstrates that the accuracy of subject device met the acceptance criteria, and there was no significant difference in slope, intercept, and correlation coefficient between the comparative meter or reference lab instrument.
User Performance Study
A User Performance Evaluation Study was performed to demonstrate that lay users could obtain accurate results using the subject device. The study was performed using capillary whole blood from fingertip, palm and forearm sample sites by evaluating total of 160 laypersons in multiple sites. The study result shows substantial equivalence to predicate device used in finger, palm and forearm position.
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2015
BIONIME CORPORATION C/O FENG-YU LEE PRINCIPAL CONSULTANT 29222 RANCHO VIEJO ROAD, SUITE 218 SAN JUAN CAPISTRANO CA 92675
Re: K143387
Trade/Device Name: GE Blood Glucose Monitoring System 333 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. CGA Dated: May 4, 2015 Received: May 6, 2015
Dear Feng-Yu Lee:
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. 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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : Courtney H. Lias, Ph.D.
Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
GE Blood Glucose Monitoring System 333
Indications for Use (Describe)
The GE Blood Glucose Monitoring System 333 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE Blood Glucose Monitoring System 333 is intended to be used by a single person and should not be shared.
The GE Blood Glucose Monitoring System 33 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 GE Blood Glucose Monitoring System 333 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 GE Blood Glucose Test Strips 33 are for use with the GE Blood Glucose Meter 333 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
This summary of 510(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: K143387
-
- Submitter's Identification:
BIONIME CORPORRATION NO 100, Sec. 2, Daqing St., South Dist., 40242 Taichung City, Taiwan
- Submitter's Identification:
Phone Number: 886-4-23692388 FAX Number: 886-4-22617568
c/o IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675 Contact Person: Feng-Yu Lee Phone Number: 1-949-218-0929 Fax Number: 1-949-218-0928
Date Summary Prepared: May 29, 2015
-
- Name of the Device: GE Blood Glucose Monitoring System 333
-
- Common or Usual Name: Glucose test system
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| NBW; System, Test, Blood | |||
| Glucose, Over-the-Counter | Class II | 21 CFR 862.1345 | Clinical Chemistry 75 |
| CGA; Glucose Oxidase, | |||
| Glucose | Class II | 21 CFR 862.1345 | Clinical Chemistry 75 |
4. Device Description:
4.1 The GE Blood Glucose Monitoring System 333 consists of the following devices: GE Blood Glucose Meter 333, GE Blood Glucose Test Strip 333, and Rightest Control Solution GC550. The GE333 Blood Glucose Meter and GE Blood Glucose Test Strips 333 are manufactured by BIONIME Corporation. The GE Blood Glucose Meter 333, when used with the GE Blood Glucose Test Strips 333, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE Blood Glucose Monitoring System 333 is verified by the Rightest Control Solution GC550.
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The Rightest Control Solution GC550 has been previously been cleared (K092052) and is being repackage for use with the GE Blood Glucose Monitoring System 333.
- న. Intended Use:
The GE Blood Glucose Monitoring System 333 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE Blood Glucose Monitoring System 333 is intended to be used by a single person and should not be shared.
The GE Blood Glucose Monitoring System 333 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 GE Blood Glucose Monitoring System 333 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 GE Blood Glucose Test Strips 333 are for use with the GE Blood Glucose Meter 333 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
6. Predicate Device Information:
The GE Blood Glucose Monitoring System 333 is substantially equivalent to the Rightest Blood Glucose Monitoring System noted below.
| Name: | Rightest Blood Glucose Monitoring System GM550 |
|---|---|
| Device Company: | Bionime Corporation |
| 510(K) Number: | K092052 |
| Name: | Rightest Blood Glucose Monitoring System GM550 |
| Name: | Rightest Blood Glucose Test Strips GS550 |
| Name: | Rightest Blood Glucose Control Solution GC550 |
| Device Company: | Bionime Corporation |
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Comparison to Predicate Devices: 7.
Specification Comparison
| New Device | Predicate Device | |
|---|---|---|
| Item | GE Blood Glucose | |
| Monitoring System 333 | Rightest GM550 | |
| Similarities | ||
| Measuring Range | 20-600 mg/dL | |
| Sample | Capillary whole blood (finger, palm and forearm) | |
| Measurement Technology | Oxidase Electrochemical Sensor | |
| Strip Reagent | 1.Glucose Oxidase (GOD) 14.8% | |
| 2.Potassium ferricyanide 39.5% | ||
| 3.Non-reactive ingredients 45.7% | ||
| The unit of measurement data | Fix on mg/dL | |
| Shelf Life after opened vial | 3 months | |
| Test Time | 5 seconds | |
| Coding | Auto coding | |
| Operating Temperature Range | 50~104 °F (10 ~ 40°C) | |
| Operating Relative Humidity | ||
| Range | 10 ~ 90% | |
| Test Strip Storage Conditions | 39~86 °F (4 ~ 30°C), |