(366 days)
The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary drawn from the fingertips, venous and arterial whole blood samples. The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by health care professionals in a clinical setting:
The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.
The PRECICHEK KP Blood Glucose Test Strip is for use with the PRECICHEK NS-101 POCT Professional Blood Glucose Meter to quantitatively measure glucose in fresh capillary drawn from the fingertips, venous and arterial whole blood samples.
The PRECICHEK Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals to assess the performance of the PRECICHEK NS-101 POCT Professional Blood Glucose monitoring system and the PRECICHECK KP Blood Glucose Test strips to check that the meter and test strips are working together properly and that the test is performing correctly.
PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System consists of:
- (1) Glucose Meter
- (2) Glucose Test Strips
- (3) Two levels of glucose control solutions (Level I and Level II) may be purchased separately. Glucose control solutions were previously cleared under K032985.
- (4) Check Strip
- (5) Instruction for use
[Test Principle]
The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor.
When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use.
[Control Solution]
The PRECICHEK Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals to assess the performance of the PRECICHEK NS-101 POCT Professional Blood Glucose monitoring system and the PRECICHECK KP Blood Glucose Test strips. There are two levels of controls (Levels 1,2).
[Check Strip]
The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover.
[Device Calibration]
The device is calibrated by implicit coding process. The code number is the last two digits of the strip lot number. The user should input the strip lot number into the memory of the meter before use.
While performing the blood glucose test, the strip lot number printed on the vial label is scanned to match the one in the memory. The meter will apply formula including this parameter to calculate the glucose value.
The provided 510(k) summary (K113314) describes the PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System. The summary states that the device's performance was evaluated against the standard ISO 15197:2003.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
The summary explicitly states that the device is compliant with ISO 15197:2003 for in vitro diagnostic test systems for blood glucose monitoring. The key performance criteria from this standard (and assuming the device met them as stated in the summary) are:
| Acceptance Criteria (from ISO 15197:2003) | Reported Device Performance |
|---|---|
| Accuracy (System Accuracy): | Met Acceptance Criteria |
| - For glucose concentrations |
§ 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.