(274 days)
The NoCoding1 Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The NoCoding1 Plus Blood Glucose Monitoring System is intended for self-testing outside the body (for in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The NoCoding1 Blood Glucose Test Strips are for use with the NoCoding1 Plus Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.
The NoCoding1 Glucose Control Solutions are for use with the NoCoding1 Plus Blood Glucose Meters and NoCoding1 Blood Glucose Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.
The NoCoding1 Plus Blood Glucose Monitoring System (BGMS) consists of a blood glucose meter, single use test strips, and control solutions with two different glucose concentrations (“Control A" and "Control B" ranges). The NoCoding1 Plus BGMS is based on an electrochemical biosensor technology (electrochemical). The System measures the glucose level in whole blood samples using a small electrical current generated in the test strips.
The following items are included in the NoCoding1 Plus Blood Glucose Monitoring system:
- 1 NoCoding1 Plus Blood Glucose Meter
- 10 NoCoding1 Blood Glucose Test Strips
- 1 Lancing device
- 10 Lancets
- 1 Owner's Booklet
- 1 Quick Reference Guide
- 2 Batteries (3.0V lithium batteries)
The following items are compatible with the NoCoding1 Plus BGMS and are available separately.
NoCoding1 Glucose Control Solution (cleared in K080923)
Here's a breakdown of the acceptance criteria and study details for the NoCoding1 Plus Blood Glucose Monitoring System, based on the provided document:
Acceptance Criteria and Reported Device Performance
The document states that the NoCoding1 Plus BGMS was tested in accordance with ISO 15197, which would define the acceptance criteria for its analytical performance. While specific numerical acceptance criteria from ISO 15197 are not explicitly listed in detail for each test alongside the device's reported performance, the summary consistently states that the device met the acceptance criteria for each test. For tests where specific numerical acceptance criteria are mentioned (e.g., linearity, hematocrit effect), they are presented alongside the observed performance.
Note: The provided text refers to "Primary and Reference criteria" being met for user performance, which likely corresponds to the ISO 15197 accuracy requirements (e.g., within ±15 mg/dL or ±15%).
| Acceptance Criteria (from ISO 15197, or implied from context) | Reported Device Performance (NoCoding1 Plus BGMS) |
|---|---|
| Repeatability Test: | The pooled SD for concentration intervals 1 and 2 were 1.9 and 2.1 mg/dL, respectively (below 5.0 mg/dL). The pooled CV% for concentration intervals 3, 4, and 5 were 2.8%, 2.6%, and 3.2%, respectively (below 5.0%). All three lots met the acceptance criteria. |
| Intermediate Precision: | The pooled SD for concentration interval 1 was 1.4 mg/dL. The pooled CV for concentration intervals 2 and 3 were 3.0% and 2.4%, respectively. Met the acceptance criteria. |
| Linearity Test: | Acceptance Criteria: Within ±10 mg/dL for glucose concentrations 100 mg/dL. |
Reported Performance: Biases of individual BGMS measurements from YSI were less than 10 mg/dL and 10% below 80 mg/dL and above 100 mg/dL, respectively. No significant interference within 15% to 65% hematocrit levels. |
| Interference Test: | Acceptance Criteria: No significant effect on glucose measurement from interferents.
Reported Performance: The 24 interferents studied showed no effect on glucose measurement at both low and high glucose concentration intervals. |
| Altitude Test: | Acceptance Criteria: Individual results not showing significant difference (±10%) with respect to reference equipment or different altitudes.
Reported Performance: Individual results did not show significant difference (±10%) with respect to the reference equipment, nor with different altitudes at all glucose concentrations. No systematic response to altitudes up to 10,000 feet (3,048m). |
| Operating Condition Test: | Acceptance Criteria: Individual meter measurements giving less than 10 mg/dL or 10% bias from YSI reference results.
Reported Performance: Individual meter measurements gave less than 10 mg/dL or 10% bias from YSI reference results. Operates normally at presented conditions (6°C to 44°C and 10% to 90% RH). |
| Sample Volume Test: | Acceptance Criteria: Meter bias from YSI within acceptance criteria.
Reported Performance: The smallest volume required for accurate measurement was 0.5 uL, and the meter bias from YSI was all within the acceptance criteria. |
| User Performance (Accuracy): | Acceptance Criteria (implied from meeting "Primary and Reference criteria," likely based on ISO 15197):
- For glucose concentration
§ 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.