(244 days)
The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The AgaMatrix Jazz ™ Wireless 2 Blood Glucose Monitoring System is intended for selftesting outside the body (In vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.
The AgaMatrix Jazz™ Blood Glucose Test Strips are for use with the AgaMatrix Jazz™ Wireless 2 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System includes the AgaMatrix Jazz™ Wireless 2 Blood Glucose Meter and the AgaMatrix Jazz™ Blood Glucose Test Strips. The apply blood symbol is displayed for the user to apply blood to the test strip until the meter begins the test. When enough blood has been applied to the strip electrodes the meter detects trigger current from the test strip initiating the test countdown. When the countdown is complete a test result is displayed on the meter screen. The unit of measure displayed on the meter screen is fixed in mg/dL and cannot be modified by the user.
The following items are included in the AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System:
- 1 AgaMatrix Jazz™ Wireless 2 Glucose Meter .
- . 1 Owner's Guide
- . 1 Carry Case
- 1 AgaMatrix Lancing Device .
- . 10 AgaMatrix Lancets
- AgaMatrix Jazz™ Blood Glucose Test Strips -
- -1 Meter Pairing & Syncing Guide
The following items are compatible with the AgaMatrix Jazz™ Wireless 2 Glucose Monitoring System and are available separately:
Here's a summary of the acceptance criteria and the study details for the AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System, extracted from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a single consolidated table with corresponding performance. However, based on the Performance Characteristics section, the implicit acceptance criteria are derived from standard deviations, coefficients of variation (CV%), and percentages of agreement within certain error ranges when compared to a reference method (YSI 2300 Glucose Analyzer).
Analytical Performance (Precision/Reproducibility):
| Glucose Concentration (mg/dL) | Acceptance Criteria (Implicit from Industry Standards/FDA Guidance) | Reported Device Performance (CV%) |
|---|---|---|
| 30-50 | Not explicitly stated, but generally low CV% is desired | Combined: 9.0% (SD: 2.9 mg/dL) |
| 51-110 | Not explicitly stated, but generally low CV% is desired | Combined: 4.3% (SD: 4.2 mg/dL) |
| 111-150 | Not explicitly stated, but generally low CV% is desired | Combined: 3.2% (SD: 4.1 mg/dL) |
| 151-250 | Not explicitly stated, but generally low CV% is desired | Combined: 3.5% (SD: 7.7 mg/dL) |
| 251-400 | Not explicitly stated, but generally low CV% is desired | Combined: 4.0% (SD: 15.3 mg/dL) |
| Intermediate Precision | ||
| Control Level 1 (57 mg/dL) | Not explicitly stated, but generally low CV% is desired | Lot 1: 2.8%, Lot 2: 3.7%, Lot 3: 3.1% |
| Control Level 2 (134-137 mg/dL) | Not explicitly stated, but generally low CV% is desired | Lot 1: 2.6%, Lot 2: 2.1%, Lot 3: 2.3% |
| Control Level 4 (342-345 mg/dL) | Not explicitly stated, but generally low CV% is desired | Lot 1: 2.5%, Lot 2: 2.6%, Lot 3: 2.2% |
Method Comparison (System Accuracy) with YSI Reference:
This part of the study is crucial for demonstrating device accuracy against a recognized standard. The acceptance criteria for blood glucose monitoring systems are typically based on ISO 15197:2013, which specifies accuracy requirements. Although the document doesn't explicitly refer to ISO 15197, the presentation of results in terms of percentage agreement within specific limits (e.g., ±5 mg/dL, ±15%) aligns with these standards.
| Glucose Concentration | Acceptance Criteria (Implied based on typically adopted standards for BGMS) | Reported Device Performance (Combined) |
|---|---|---|
| ** |
§ 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.