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510(k) Data Aggregation
(27 days)
The GLUCOCARD 01 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.
The GLUCOCARD 01 SENSOR PLUS Blood Glucose Test Strips are intended to be used with the GLUCOCARD 01 Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.
For over the counter use only
The ReliOn Confirm Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.
The ReliOn Confirm Plus Blood Glucose Test Strips are intended to be used with the ReliOn Confirm Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.
For over the counter use only
The GLUCOCARD 01 Blood Glucose Monitoring System and ReliOn Confirm Blood Glucose Monitoring System consist of a meter, test strips, and control solution for use as an aid to monitor the effectiveness of diabetes control.
The provided FDA 510(k) summary (K142336) describes the GLUCOCARD 01 Blood Glucose Monitoring System and ReliOn Confirm Blood Glucose Monitoring System. This submission focuses on modifications to certain exterior materials used in the manufacture of the meter. Therefore, the primary studies mentioned are related to demonstrating the continued safety and performance of the device despite these material changes, rather than a clinical effectiveness study of the glucose monitoring itself.
Based on the provided document, here's an analysis of the acceptance criteria and supporting studies related to the modifications:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Material Modifications Safety | Viral elimination effectiveness | Studies were conducted on the surfaces of the GLUCOCARD 01 and ReliOn Confirm Meters. (Specific results not detailed in this summary, but the conclusion states substantial equivalence.) |
| Cleaning and Disinfection Durability | Withstand multiple cleaning and disinfection cycles | Testing was performed to demonstrate that the GLUCOCARD 01 and ReliOn Confirm meters can withstand multiple cleaning and disinfection cycles. (Specific results not detailed in this summary, but the conclusion states substantial equivalence.) |
| Physical Durability | Robustness of meter case design (e.g., drop, button durability) | Drop testing and button durability studies demonstrate that the material changes do not affect the robustness of the meter case design. (Specific results not detailed in this summary, but the conclusion states substantial equivalence.) |
2. Sample Size and Data Provenance for Test Set
The document does not specify sample sizes for the viral elimination, cleaning/disinfection, or drop/button durability test sets. It also does not explicitly state the provenance (e.g., country of origin) of the data for these engineering/material tests. These are typically simulated or laboratory tests rather than patient data.
3. Number of Experts to Establish Ground Truth and Qualifications
This information is not provided in the document. For engineering/material tests, "ground truth" would typically be established by established test methodologies and internal validation, rather than expert consensus in the clinical sense.
4. Adjudication Method
This information is not provided as it is not relevant for the type of engineering/material testing described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. This type of study is more relevant for AI/radiology devices where human interpretation is a key component. The device described is a glucose meter, and the submitted changes are material-related.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study of an algorithm was conducted or described in this summary. The device's primary function is a measurement system; the "performance" here refers to the physical and safety aspects after material changes.
7. Type of Ground Truth Used
For the safety and durability tests:
- Viral elimination effectiveness: The ground truth would be established by predefined microbiological assay standards and protocols to determine the reduction of viral load on surfaces.
- Cleaning and disinfection durability: The ground truth would be resistance to degradation or damage after exposure to specified cleaning agents and cycles, measured against physical and functional integrity criteria.
- Physical durability (drop/button): The ground truth would be the device's ability to remain functional and intact after specified mechanical stresses, measured against established engineering and performance specifications.
8. Sample Size for the Training Set
No training set is mentioned in the context of these material modification studies. This typically refers to machine learning models, which are not described here.
9. How Ground Truth for Training Set Was Established
Not applicable, as no training set was identified.
Summary of the K142336 Submission Context:
It's important to note that this 510(k) submission (K142336) is for modifications to an already cleared predicate device (K124021). The "Reason for Submission" explicitly states "Modifications to certain exterior materials used in the manufacture of the meter." This means the core functionality and clinical accuracy of the glucose measurement system were likely established in the predicate submission. The studies presented here are specifically to demonstrate that the new materials do not adversely affect the device's safety (e.g., viral transmission risk, ability to be disinfected) or durability, thereby maintaining substantial equivalence to the predicate.
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(39 days)
The GLUCOCARD 01-mini Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.
The GLUCOCARD 01 SENSOR PLUS Blood Glucose Test Strips are intended to be used with the GLUCOCARD 01-mini Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.
The ReliOn Micro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.
The ReliOn Micro Plus Blood Glucose Test Strips are intended to be used with the ReliOn Micro Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.
The GLUCOCARD 01-mini Blood Glucose Monitoring System and ReliOn Micro Blood Glucose Monitoring System consist of a meter, test strips, and control solution for use as an aid to monitor the effectiveness of diabetes control.
This document describes the 510(k) premarket notification for the GLUCOCARD 01-mini Blood Glucose Monitoring System and the ReliOn Micro Blood Glucose Monitoring System, which are intended for quantitative measurement of glucose in fresh capillary whole blood samples.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state the quantitative acceptance criteria for system accuracy in a table format, nor does it provide detailed numerical results of the device's performance against such criteria. It generally states that a "clinical study was done with persons with diabetes to evaluate system accuracy."
However, glucose monitoring systems like this are typically evaluated against standards like ISO 15197 for accuracy. A common acceptance criterion for blood glucose meters, as per ISO 15197, often includes:
- 95% of results falling within ±15 mg/dL of the reference method for glucose concentrations
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(550 days)
The GLUCOCARD 01 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.
The ReliOn Confirm Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.
The GLUCOCARD 01 Blood Glucose Monitoring System and ReliOn Confirm Blood Glucose Monitoring System consist of a meter, test strips, and control solution for use as an aid to monitor the effectiveness of diabetes control.
The GLUCOCARD 01 Blood Glucose Monitoring System and ReliOn Confirm Blood Glucose Monitoring System did not include AI, therefore much of this information is not applicable.
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria (e.g., specific percentages for accuracy within certain glucose ranges) or detailed performance statistics were provided in the document beyond a general statement of positive clinical study results.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "A clinical study was conducted with persons with diabetes to evaluate system accuracy and to assess ease of use." However, the sample size for this clinical study and the data provenance (country of origin, retrospective or prospective nature) are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable, as this device measures glucose and does not typically involve expert interpretation as a ground truth method.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as this device measures glucose and does not involve human readers interpreting cases or AI assistance in that context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a standalone blood glucose monitoring system. Its "performance" refers to the accuracy of its glucose measurements. The clinical study evaluated "system accuracy," which inherently means the performance of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For blood glucose monitoring systems, the ground truth for accuracy studies is typically established by comparing the device's readings to a laboratory reference method (e.g., a central lab analyzer) known for its high accuracy in measuring blood glucose. The document does not explicitly state the specific ground truth method used, but it's universally implied for such devices.
8. The sample size for the training set
Not applicable, as this device does not utilize an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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