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510(k) Data Aggregation
(76 days)
The GluNEO™ Lite Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The Glubert Lite Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The GluNEO™ Lite Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The GluNEO™ Lite Test Strips are for use with the GluNEO™ Lite Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.
The GluNEO™ Lite Control Solutions are for use with the GluNEO™ Lite Meter and GluNEO™ Lite Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.
The GluNEO™ Lite Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh and in venous whole blood. The GluNEO™ Lite Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, singleuse lancing devices. The GluNEO™ Lite Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The GluNEO™ Lite Professional Test Strips are for use with the GluNEO™ Lite Professional Meter to quantitatively measure glucose in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips. ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.
The GluNEO™ Lite Professional Control Solutions are for use with the GluNEO™ Lite Professional Meter and GluNEOTM Lite Professional Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The GluNEO™ Lite / GluNEO™ Lite Professional Blood Glucose Monitoring System consists of a meter, test strips and control solutions (level 2 and level 3), a lancing device and sterile lancets. With the GluNEOTM Lite Professional Blood Glucose Monitoring System, only auto-disabling or single use lancing device must be used. This blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.
Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the GluNEO™ Lite / GluNEO™ Lite Professional Blood Glucose Monitoring System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document refers to meeting the requirements of ISO 15197:2003 for performance. While the specific numerical acceptance criteria from ISO 15197:2003 are not explicitly listed in the summary, they are a well-established international standard for blood glucose monitoring systems. For the purpose of this response, I will state the criteria as per ISO 15197:2003 and then interpret the "reported device performance" based on the general statement in the document that the device "passed all of the tests based on pre-determined Pass/Fail criteria."
Implicit Acceptance Criteria (based on ISO 15197:2003 for glucose meters) and Reported Device Performance:
| Acceptance Criteria (ISO 15197:2003 - general, actual ranges depend on glucose concentration) | Reported Device Performance (as stated or implied) |
|---|---|
| Accuracy (System Accuracy): | Met (Device passed all tests against pre-determined Pass/Fail criteria.) |
| - For glucose concentrations < 4.2 mmol/L (75 mg/dL): ≥ 95% of results within ± 0.83 mmol/L (± 15 mg/dL) of reference method. | The summary states the device passed all tests based on pre-determined Pass/Fail criteria, implying these accuracy metrics were met. The specific percentages or deviations are not provided. |
| - For glucose concentrations ≥ 4.2 mmol/L (75 mg/dL): ≥ 95% of results within ± 20% of reference method. | |
| Precision (Repeatability/Intermediate Precision): (Typically assessed through coefficients of variation (CV%) at various glucose levels) | Met (Device passed all tests against pre-determined Pass/Fail criteria.) |
| Interfering Substances: (No significant interference from common substances) | Met (Implied by passing all tests, as interference studies are part of ISO 15197.) |
| Hematocrit Effects: (Accurate readings across a specified hematocrit range) | Met (Implied by passing all tests.) |
| Temperature and Humidity Effects: (Maintained performance across specified environmental conditions) | Met (Implied by passing all tests.) |
| Usability/User Performance: (Demonstrated acceptable results when used by lay-users) | Met (Clinical evaluation included user performance.) |
Note: The 510(k) summary does not provide specific numerical results (e.g., percentages of results within limits) but rather a high-level statement that the device "passed all of the tests based on pre-determined Pass/Fail criteria" in accordance with ISO 15197:2003.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Clinical evaluation included method comparison, matrix comparison. user performance and alternative-site blood glucose measurement." Standard practice for ISO 15197 usually involves a minimum number of subjects (e.g., ~100 subjects for system accuracy, with capillary and venous blood samples per subject). However, the exact number used in this specific study is not provided.
- Data Provenance: Not explicitly stated. The applicant is Infopia Co., Ltd. from the Republic of Korea, but the location where the clinical evaluations were conducted is not mentioned. It is common for such studies to be conducted in a sponsor's home country or in clinical sites that meet regulatory requirements.
- Retrospective or Prospective: Not explicitly stated. Clinical evaluations, especially user performance and method comparison studies, are typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the summary. For blood glucose monitoring systems, the "ground truth" (reference method) is typically established using a highly accurate laboratory reference method (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer or similar) which is operated and calibrated by trained laboratory personnel, rather than "experts" in the sense of clinicians establishing a diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable/provided in the context of a blood glucose monitoring system's accuracy study. Adjudication methods (like 2+1, 3+1, etc.) are typically used in studies where human readers interpret medical images or clinical data, and their disagreements need to be resolved to establish ground truth or evaluate diagnostic performance. For glucose meters, the reference value is determined by a precise laboratory instrument.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. MRMC studies are designed to compare the diagnostic performance of different readers (human or AI) across multiple cases, often in radiology or pathology. This submission concerns the accuracy and performance of a blood glucose meter, which is a quantitative measurement device, not an interpretive diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
Yes, a standalone performance evaluation was done. The "Performance Data" section states, "Non-clinical performance evaluations were conducted to establish the performance, functionality and reliability characteristics of the GluNEO™ Lite / GluNEO™ Lite Professional Blood Glucose Monitoring System." This refers to evaluating the device itself (meter and strips) against reference methods in a laboratory setting, independent of human user interaction for measuring accuracy. Additionally, "Clinical evaluation included method comparison" directly assesses the device's numerical output against a reference method. The "user performance" study then evaluates the device's performance when used by humans.
7. The Type of Ground Truth Used
The ground truth used would be a laboratory reference method for glucose measurement (e.g., a hexokinase-based enzymatic method on a high-precision analyzer like a YSI analyzer). The summary states "method comparison," which implies comparing the device's readings against such a reference method.
8. The Sample Size for the Training Set
This information is not applicable/provided. Blood glucose monitoring systems like the GluNEO™ Lite typically do not use a "training set" in the machine learning sense. Their calibration and algorithms are established during the manufacturing and development phase using controlled experiments and chemical principles, not through machine learning on large datasets that require separate training and test sets.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided for the reasons stated in point 8. The calibration of the device's algorithm (how it converts the electrical signal from the test strip into a glucose reading) is established during development, likely using precisely prepared glucose solutions and reference measurement techniques to define the relationship between the electrical signal and glucose concentration.
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