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.

Device Description

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.

AI/ML Overview

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 < 75 mg/dL (4.2 mmol/L): At least 95% of results shall fall within ±15 mg/dL (±0.83 mmol/L) of the reference method.	"the results demonstrated that the predetermined acceptance criteria were fully met."
- For glucose concentrations ≥ 75 mg/dL (4.2 mmol/L): At least 95% of results shall fall within ±20% of the reference method.	"the results demonstrated that the predetermined acceptance criteria were fully met."
Precision (Repeatability/Intermediate Precision):	Met Acceptance Criteria
- No specific numerical values for precision are listed in this document, but compliance with ISO 15197:2003 implies acceptable precision performance.	"the results demonstrated that the predetermined acceptance criteria were fully met."
Linearity:	Met Acceptance Criteria
- No specific numerical values for linearity are listed in this document, but compliance with ISO 15197:2003 implies acceptable linearity across the measuring range.	"the results demonstrated that the predetermined acceptance criteria were fully met."
Interference:	Met Acceptance Criteria
- No specific numerical values for interference are listed in this document, but compliance with ISO 15197:2003 implies acceptable performance in the presence of common interfering substances.	"the results demonstrated that the predetermined acceptance criteria were fully met."

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.

Summary

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K113314

510(k) Summary

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	1. Submitter Information		NOV	9 2012
	Company name:	HMD BioMedical Inc.
	Contact person:	Jessica Tung
	Address:	No. 181, Minsheng St., Xinpu Township, Hsinchu
		County, Taiwan
	Phone:	886-3-6017000
	FAX:	886-3-5885500
	E-mail:	jessica-tung@hmdbio.com
	Date Prepared:	Apr. 30, 2012

1. Name of Device
  :

Trade/Proprietary Name:

	PRECICHEK NS-101 POCT Professional Blood
	Glucose Monitoring System
Common name:	Blood Glucose Test System
Classification name:	Glucose Test System
Classification Panel:	Clinical Chemistry (75)
Regulation no.:	862.1345 (Class II), 862.1660 (Class I)
Product code:	LFR, JJX
Panel:	Clinical Chemistry (75)

1. Predicate Device

Trade/Proprietary name:	SureStepFlexx Professional Blood GlucoseManagement System
Common name:	Blood Glucose Test System
Submitter:	Life Scan, Inc.
510(k) no.:	K023194
Product code:	NBW, CGA

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Common name: Glucose Control Solution Submitter: HMD Biomedical, Inc. K032985 510(k) no.: אננ Product code:

1. Device Description
  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.

[Control Solution]

The PRECICHEK Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals to

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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.

5. Intended Use

PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System

The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, venous whole blood and arterial whole blood. The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.

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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 (sugar) in fresh capillary whole blood from the fingertips, venous whole blood and arterial whole blood.

1. Comparison of Subject Devices and predicate device
  Technological Characteristics Comparison Table of PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System and LifeScan SureStep Flexx Professional Blood Glucose Management System (K023194)

Item	Subject Device	Predicate Device
Similarities
Indication of Use	It is designed to quantitativelymeasure the concentration ofglucose (sugar) in capillary,venous, and arterial wholeblood by healthcareprofessionals to monitorpatient's blood glucose inclinical settings. The system isused outside the body (in vitrodiagnostic).	Same
Code system	Bar code	Same
	PRECICHEK NS-101 POCTProfessional BGMS	LifeScan SureStep FlexxProfessional BGMS
Blood samplesource	Fresh whole blood (capillary,venous, arterial)	Same
Warming &Precaution	For in-vitro diagnostic use only	Same
Calibration	Plasma Equivalent	Same
OperatingProcedure	Menu controlOperational ID, Patient ID,Strip Lot	Same
Test Mode	Glucose Control Solution test,Capillary test, Venous test,Arterial test.	Same
Characteristics	For professional use only	Same
Differences
Dimensions	143 x 65 x 33mm	161 x 90 x 41mm
Biological Source	Glucose Dehydrogenase	Glucose Oxidase
Principle	Electrical chemistry reaction	Photochemical Reaction
Blood samplevolume	0.5uL	5-30uL
Buttons	Power, Scan, numbers	Power
Weight	200g (with battery)	375g (with battery)
Reaction time	5 seconds	30 seconds
Blood GlucoseRange	20-600mg/dl	0-500 mg/dl
OperationalEnvironment	10-40℃, 50-104℉	18-30℃, 64-86℉
Environment	20-80% RH	30-70%
Power Source	3.7V Li rechargeable via USBbattery	3 AA 1.5v alkaline batteries

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7. Discussion of Clinical Tests Performed

PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System (Subject Device) is compliant to the standard of ISO 15197:2003 In vitro diagnostic test systems- Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. All the relevant activities were performed by professionals and

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the results demonstrated that the predetermined acceptance criteria were fully met.

1. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
  The subject device was tested to evaluate its safety and effectiveness, including the followings:
ISO 15197:2003 In vitro diagnostic test systems Requirements (1) for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
IEC 60601-1:1988 + A1:1991 + A2:1995 Medical electrical (2) equipment - Part 1: General requirements for safety
IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: (3) General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility-Requirements and tests
(4) . CLSI/NCCLS EP05-A2: Evaluation of Precision Performance of Quantitative Measurement Methods
(5) CLSI EP06-A: Evaluation of the Linearity of Quantitative Measurement.
CLSI EP07-A2: Interference Testing in Clinical Chemistry (6)
CLSI/NCCLS EP09-A2: Method Comparison and Bias Estimation (7) Using Patient Samples
FDA Guidance: Guidance for the Content of Premarket (8) Submissions for Software Contained in Medical Devices, May 11, 2005
1. Conclusion

The subject device was tested and fulfilled the requirements from those standards mentioned above, and it's concluded that the subject device is substantially equivalent to the predicate device.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The text is in all caps and appears to be in a sans-serif font.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 9, 2012

HMD Biomedical Inc. c/o Wang Yunhan No. 181, Minsheng St Xinpu Township, Hsinchu County Taiwan

Re: K113314

Trade/Device Name: PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: LFR, JJX Dated: October 26, 2012 Received: October 31, 2012

Dear Wang Yunhan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Wang Yunhan

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benson

for

Courtney H. Lias, Ph.D Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): | ||3314

Device Name [Trade Name]:

PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use _ AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Lallum Lumo

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KII 33 14

Page 1 of __

Regulation Number and Section

§ 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.