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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:

Note: The summary states, "All the relevant activities were performed by professionals and the results demonstrated that the predetermined acceptance criteria were fully met." However, it does not provide the numerical performance data in terms of specific percentages, standard deviations, or bias values. It only provides a general statement of compliance with the ISO standard.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The summary does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It only mentions that compliance with ISO 15197:2003 was demonstrated. This standard typically requires a minimum number of samples for accuracy evaluation (e.g., at least 100 patient samples with a distribution across the measuring range).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the summary. For blood glucose monitoring systems, the "ground truth" (reference method) is typically established by laboratory-based glucose analyzers, not by human experts in the same way as imaging diagnostics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and therefore not provided in the summary. Adjudication methods like "2+1" are relevant for expert review of medical images or clinical cases, not for objective biochemical measurements like blood glucose.

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 and therefore not provided in the summary. The device is a blood glucose monitoring system, not a diagnostic imaging AI tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the study performed was a standalone performance evaluation of the device. The PRECICHEK NS-101 POCT system is designed to provide a direct quantitative measurement of glucose, without human interpretation in the loop to determine the glucose value itself (though human users operate the device and interpret the numerical result). The stated compliance with ISO 15197:2003 directly assesses the accuracy and performance of the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for blood glucose monitoring systems is typically established using a laboratory reference method, such as a hexokinase or glucose oxidase method on a high-precision clinical chemistry analyzer. While not explicitly stated, compliance with ISO 15197 suggests that the device's measurements were compared against such a validated reference method.

8. The sample size for the training set

This information is not applicable and therefore not provided in the summary. The device in question is a biosensor-based system for direct measurement, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its calibration is described as an "implicit coding process" based on strip lot numbers, which is a manufacturing calibration rather than algorithm training.

9. How the ground truth for the training set was established

This information is not applicable as there is no "training set" for an algorithmic model in the context of this device. The device's calibration mechanism ("implicit coding process") is described as matching a strip lot number to a formula in the meter, which is a factory-set calibration, not a learned model based on a ground-truthed training set.

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