(115 days)
AgaMatrix LibertyTM Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip and palm of the hand. 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, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
AgaMatrix Liberty™ Blood Glucose Meter is intended for use with AgaMatrix Liberty™ Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip and palm of the hand. 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, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
AgaMatrix Liberty™ Blood Glucose Test Strips are intended for use with AgaMatrix Liberty™ Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip and palm of the hand. 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, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
AgaMatrix Liberty™ Control Solutions are intended for use with the AgaMatrix Liberty™ Meter and AgaMatrix Liberty™ Test Strips as a quality control check to verify the accura results.
The AgaMatrix Liberty™ Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, quick start guide, reference guide, owner's booklet, and warranty/ registration card. Test Strips, Lancing device, Lancets, and Control Solution are purchased separately.
It is intended for over-the-counter home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by healthcare professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument.
The provided text describes the AgaMatrix Liberty™ Blood Glucose Monitoring System and its 510(k) submission, confirming its substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria or the specific study data that definitively proves the device meets those criteria.
The document mentions compliance with ISO 15197:2003, which sets requirements for blood glucose monitoring systems for self-testing. This ISO standard would contain the acceptance criteria for accuracy, but the document itself does not explicitly list these criteria or the specific performance metrics achieved by the AgaMatrix Liberty™ system against them.
Therefore, the requested information in the prompt cannot be fully extracted from the provided text.
Here's what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in the document. The document refers to compliance with ISO 15197:2003, which would define these criteria, but the specific numerical targets for accuracy (e.g., within X% or Y mg/dL of a reference method) are not provided.
- Reported Device Performance: Not explicitly stated in the document in numerical terms that can be directly compared to acceptance criteria. The document states "The new device contains additional features compared to the predicate device. These additional features include faster test time, smaller sample size, and better accuracy." and "The system performs as intended and raises no new safety of effectiveness issues." While "better accuracy" is mentioned, no quantitative data is given.
Missing Information (based on the provided text):
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned, as no specific clinical study details are provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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. This device is a blood glucose monitor, not an AI-assisted diagnostic imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable in the context of typical AI performance studies. This is a point-of-care diagnostic device. Its performance is inherent to the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but for a blood glucose monitor, the ground truth would typically be established by a laboratory reference method (e.g., a YSI analyzer).
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.
Summary of what can be extracted:
The device is the AgaMatrix Liberty™ Blood Glucose Monitoring System. It gained 510(k) clearance by demonstrating substantial equivalence to the Ascensia Contour Blood Glucose Monitoring System (K023657). The manufacturer certifies compliance with ISO 15197:2003, which is the relevant standard for blood glucose monitoring systems' accuracy. However, the specific data from the studies (sample sizes, detailed accuracy metrics, ground truth methods, etc.) are not included in this 510(k) summary document.
§ 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.