(30 days)
AgaMatrix JAZZ™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm, and/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.
AgaMatrix JAZZ™ Blood Glucose Meter is intended for use with AgaMatrix JAZZ™ Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm, and/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.
AgaMatrix JAZZ™ Blood Glucose Test Strips are intended for use with AgaMatrix JAZZ™ Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm and/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.
AgaMatrix JAZZ™ Control Solutions are intended for use with the AgaMatrix JAZZ™ Meter and AgaMatrix JAZZ™ Test Strips as a quality control check to verify the accuracy of blood glucose test results.
The AgaMatrix WaveSense JAZZ™ Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, Lancing device, lancets, control solution and owner's booklet. Test Strips are sold 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 is a 510(k) Summary for the AgaMatrix WaveSense JAZZ™ Blood Glucose Monitoring System, dated August 17, 2007. It states the device's intended use and that it complies with ISO 15197:2003, but it does not contain information about specific acceptance criteria or a study proving the device directly meets acceptance criteria for accuracy with detailed performance metrics.
The document discusses the device's modification (no coding required), intended use, and compliance with various international standards, including ISO 15197:2003 ("In vitro diagnostic test systems- Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus"). While compliance with ISO 15197 generally implies meeting certain accuracy standards, the specific performance data (e.g., mean absolute relative difference (MARD), percentages within certain error grids) are not present in this summary.
Therefore, I cannot fulfill all parts of your request based solely on the provided text.
Here's what I can provide based on the given information, along with explanations for the missing elements:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document states compliance with ISO 15197:2003. This standard sets performance requirements for blood glucose monitoring systems.
- ISO 15197:2003 Acceptance Criteria (generally, not explicitly stated in the document, but implied by compliance):
- For glucose concentrations
- ISO 15197:2003 Acceptance Criteria (generally, not explicitly stated in the document, but implied by compliance):
§ 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.