(60 days)
The Liberty™ Blood Glucose Monitoring System is intended to quantitatively measure blood glucose levels, also known as blood sugar, from fresh capillary whole blood samples taken from the fingertips, palm, or forearm. The Liberty, TM Test Strips are for in vitro diagnostic (outside of the body) use only. The Liberty™ System is not intended for use with neonates.
AgaMatrix Liberty " Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip, palm, or forearm. 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. It is not intended for use with neonates.
AgaMatrix Liberty™ Blood Glucose Meter is intended for use with AgaMatrix Liberty™ Blood Glucose Test Strips for the quantitative measurement of glucose in frearians courty whole blood. Testing sdone outside the body (in viro 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 effectiveress 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. 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 effective of por diabetes control.
AgaMatix Liberty™ Control Solutions are intended for use with the AgaMarix Libery™ Meter and AgaMatix Liberty™ Test Stri results.
The AgaMatrix Liberty™ Blood Glucose Monitoring System includes a meter with batteries, compact carrying casc, 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 510(k) summary for the AgaMatrix Liberty™ Blood Glucose Monitoring System (K063409) does not contain detailed information regarding the specific acceptance criteria and the comprehensive study results as typically expected for device validation.
Instead, it states that the device complies with certain ISO and IEC standards, which imply conformance to established performance requirements. However, the specific numerical acceptance criteria (e.g., accuracy percentages, precision limits) and the detailed results of studies demonstrating compliance are not explicitly provided in the given text.
Based on the provided document, here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly stated in the provided text. The document refers to compliance with ISO 15197:2003, which sets performance requirements for blood glucose monitoring systems for self-testing. However, the specific numerical criteria (e.g., accuracy within a certain percentage of a reference method) and the device's measured performance against those criteria are not listed.
2. Sample size used for the test set and the data provenance:
This information is not explicitly stated in the provided text. The document mentions "Testing" but does not detail the sample sizes for patient samples or control samples, nor their country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not explicitly stated in the provided text. For blood glucose monitoring systems, "ground truth" is typically established by laboratory reference methods, not by expert consensus on visual assessment.
4. Adjudication method for the test set:
This information is not applicable/not explicitly stated in the context of a blood glucose monitoring system's performance testing. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation) where multiple readers provide their opinion. For quantitative measurements like blood glucose, accuracy is determined by comparison to a reference method.
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:
This information is not applicable. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device that involves human readers interpreting cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not explicitly stated but is implicitly the primary mode of operation for a blood glucose meter. The "device performance" would inherently be its standalone performance, as it provides a direct measurement rather than an interpretation to a human.
7. The type of ground truth used:
This is not explicitly stated, but for blood glucose monitoring systems, the ground truth is universally established by laboratory reference methods (e.g., YSI analyzer). The document mentions "in vitro diagnostic (outside of the body) use only," which confirms the nature of the testing.
8. The sample size for the training set:
This information is not applicable/not explicitly stated. "Training set" refers to data used to develop and train machine learning models. A blood glucose monitoring system, based on electrochemical principles, does not typically involve a "training set" in the machine learning sense. Its performance is based on its sensor technology and calibration, not learned patterns from a dataset.
9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated in point 8.
Summary of available and missing information:
| Category | Information from Document |
|---|---|
| 1. Acceptance Criteria & Reported Performance | Not explicitly stated in numerical form. The document states compliance with ISO 15197:2003, which outlines general requirements for blood glucose monitoring systems, but the specific performance results against these criteria are not provided. |
| 2. Test Set Sample Size & Data Provenance | Not explicitly stated. "Testing" is mentioned, but details on sample size, country of origin, or retrospective/prospective nature are absent. |
| 3. Experts for Ground Truth & Qualifications | Not applicable. Ground truth for blood glucose meters is typically a lab reference method, not expert consensus. |
| 4. Adjudication Method | Not applicable. Adjudication methods (e.g., 2+1) are for subjective assessments, not for quantitative measurements like blood glucose. |
| 5. MRMC Comparative Effectiveness Study (AI assistance) | Not applicable. This is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device. |
| 6. Standalone Performance | Implicitly done. The device's performance as a blood glucose meter would inherently be its standalone performance. |
| 7. Type of Ground Truth Used | Implicitly, laboratory reference methods. While not directly stated, "in vitro diagnostic" and the nature of blood glucose testing imply comparison to highly accurate laboratory analyzers. |
| 8. Training Set Sample Size | Not applicable. This device uses electrochemical technology, not machine learning that requires a "training set." |
| 9. Ground Truth for Training Set | Not applicable. (See point 8) |
To get the specific acceptance criteria and detailed study results, one would typically need to refer to a more detailed clinical study report or the full submission documentation to the FDA, which is not provided in this 510(k) summary. The summary focuses on establishing substantial equivalence based on identical technological characteristics and compliance with general standards.
§ 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.