The GoodLife CS-200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife CS-200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The GoodLife CS-200 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GoodLife CS-200 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes, nor for neonatal use.

The GoodLife KP Blood Glucose Test Strips are for use with the GoodLife CS-200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

The GoodLife CS-200 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in venous or arterial whole blood or fresh capillary whole blood drawn from the fingertips. It is intended for testing outside the body (in vitro diagnostic use) and intended for multiple-patient use in professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices.

The GoodLife CS-200 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes, nor for neonatal use.

The GoodLife KP Professional Blood Glucose Test Strip is for use with the GoodLife CS-200 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in venous or arterial whole blood or fresh capillary whole blood drawn from the fingertips

Device Description

GoodLife CS-200 Blood Glucose Monitoring System and GoodLife CS-200 Professional Blood Glucose Monitoring System consist 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 GoodLife CS-200 & GoodLife CS-200 Professional Blood Glucose Monitoring System are 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 GoodLife Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) assessing the performance of the GoodLife CS-200 & GoodLife CS-200 Professional Blood Glucose Monitoring System and GoodLife KP & GoodLife KP Professional 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 Digital Code Strip. While inserting the Digital Code Strip into the coding slot, the meter will turn on automatically and complete the coding. The meter will apply formula including this parameter of code to calculate the glucose value.

AI/ML Overview

This 510(k) summary provides limited details regarding the specifics of the clinical study, making it challenging to fully address all requested information. However, based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states compliance with ISO 15197:2003. This standard defines acceptance criteria for blood glucose monitoring systems. While the specific numerical acceptance criteria from the standard are not explicitly listed in this document, the submission claims that "the predetermined acceptance criteria were fully met." Without access to the full study report or the ISO 15197:2003 standard, the exact numerical performance metrics for the device against specific thresholds cannot be detailed.

Acceptance Criteria (Based on ISO 15197:2003 Claims):

Performance Metric	Acceptance Criteria (from ISO 15197:2003, implied to be met)	Reported Device Performance
Accuracy	Not explicitly detailed in the provided text, but implied as met per ISO 15197:2003	"the predetermined acceptance criteria were fully met."
Precision	Not explicitly detailed in the provided text, but implied as met per ISO 15197:2003	"the predetermined acceptance criteria were fully met."
Other	Not explicitly detailed in the provided text, but implied as met per ISO 15197:2003	"the predetermined acceptance criteria were fully met."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in the provided 510(k) summary.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The submission is from a Taiwan-based company, which might suggest data could originate from Taiwan or other regions.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not explicitly stated in the provided 510(k) summary. For blood glucose monitoring systems, the ground truth is typically established using a reference laboratory method (e.g., YSI analyzer), not necessarily by "experts" in the same way as image interpretation.

4. Adjudication Method for the Test Set

Not applicable in the traditional sense for blood glucose monitoring systems. The "ground truth" is typically a quantitative measurement from a reference method, rather than a subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study is not relevant or typically performed for blood glucose monitoring systems. These studies are common for diagnostic imaging devices where human interpretation plays a significant role.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, the device (GoodLife CS-200 Blood Glucose Monitoring System) is a standalone system. Its performance is measured directly by comparing its readings to a reference method, without human intervention in the result generation or interpretation. The submission states, "The GoodLife CS-200 & GoodLife CS-200 Professional Blood Glucose Monitoring System are electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor." This describes a standalone, automated measurement.

7. The Type of Ground Truth Used

The ground truth for blood glucose monitoring systems is typically established using a laboratory reference method (e.g., a glucose analyzer, often a YSI analyzer), which provides a highly accurate and precise measurement of blood glucose. While not explicitly stated as "YSI" in this document, the industry standard for studies supporting ISO 15197 compliance relies on such reference methods. This falls under the category of reference standard/laboratory measurement.

8. The Sample Size for the Training Set

Not applicable and not typically mentioned for this type of device. Blood glucose meters do not usually involve a "training set" in the context of machine learning algorithms that learn from data. The device's calibration and algorithm are developed through engineering and chemical principles, not machine learning training. The "calibration" mentioned ("The device is calibrated by Digital Code Strip...") refers to a specific operational calibration for each batch of test strips, not a machine learning training process.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there isn't a "training set" in the machine learning sense for this device. The device's design, chemical reagents, and electrochemical principles are developed and validated against known glucose concentrations and reference methods during its R&D phase, but this is not framed as establishing ground truth for a "training set."

Summary

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K121433

HMD BioMedical Inc.

510(k) Summary

FEB 1 4 2013

1. Submitter Information

Company name:	HMD BioMedical Inc.
Contact person:	Jessica Tung
Address:	No. 181, Minsheng St., Xinpu Township, HsinchuCounty, Taiwan
Phone:	886-3-6017000
FAX:	886-3-5885500
E-mail:	jessica-tung@hmdbio.com
Date Prepared:	February 14, 2013

2. Name of Device

Trade/Proprietary Name:

For single patient use

GoodLife CS-200 Blood Glucose Monitoring System

For multiple patient use
GoodLife CS-200 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)
Product code:	NBW, LFR

1. Predicate Device

Trade/Proprietary name:	U-RIGHT TD-4279A Blood GlucoseMonitoring System
Common name:	Blood Glucose Test System
Submitter:	TaiDoc Technology Corporation
510(k) no.:	K101509
Product code:	NBW, LFR

Device Description

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GoodLife CS-200 Blood Glucose Monitoring System and GoodLife CS-200 Professional Blood Glucose Monitoring System consist 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]

[Control Solution]

[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]

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HMD BioMedical Inc.

5. Intended Use

The GoodLife CS-200 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes, nor for neonatal use.

The GoodLife KP Professional Blood Glucose Test Strip is for use with

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HMD BloMedical Inc.

the GoodLife CS-200 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in venous or arterial whole blood or fresh capillary whole blood drawn from the fingertips

6. Comparison of subject devices and predicate device

Technological Characteristics Comparison Table of GoodLife CS-200 Blood Glucose Monitoring System for single patient use & GoodLife CS-200 Professional Blood Glucose Monitoring System for multiple patient use and U-RIGHT TD-4279A Blood Glucose Monitoring System (K101509)

Item	Subject DeviceGoodLife CS-200 & CS-200 ProfessionalBGMS	Predicate DeviceU-RIGHT TD-4279ABGMS (K101509)
Similarities
Intended use	For single patient use (CS-200) -It is designed to quantitatively measurethe concentration of glucose in freshcapillary whole blood	Same
Detection method	Amperometry:Current produced by chemical reaction	Same
Coding function	By code strip	Same
Test range	20~600mg/dL	Same
Operating conditions	50~~104°F (10~~40°C)	Same
Test time	5 sec	Same
Capillary testing site	For single patient use (CS-200) -Fingertips only	Same
Enzyme	Glucose Dehydrogenase (FAD)	Same
Differences
Intended use	For multiple patient use (CS-200Professional) -It is designed toquantitatively measure theconcentration of glucose infresh capillary drawnfrom the fingertips, venous or	It is designed toquantitatively measure theconcentration of glucose infresh capillary whole blood.

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HMD BioMedical Inc.

	arterial whole blood samples.
Sample volume	0.5ul	1.1ul
Storage condition	50~~104°F (10~~40°C)	35.6~~89.6°F(2~~32°C)
PC data transmission	N/A	USB cable

7. Discussion of Clinical Tests Performed

GoodLife CS-200 Blood Glucose Monitoring System and GoodLife CS-200 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 the results demonstrated that the predetermined acceptance criteria were fully met.

8. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 25, 2013

HMD BioMedical Inc. c/o Jessica Tung No. 181. Minsheng St., Xinpu Township, Hsinchu County China (Taiwan) 305

Re: K121433

Trade/Device Name: GoodLife CS-200 Blood Glucose Monitoring System GoodLife CS-200 Professional Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: LFR, NBW Dated: February 07, 2013 Received: February 8, 2013

Dear Ms. Tung:

This letter corrects our substantially equivalent letter of February 14, 2013.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carol C. Benson -S 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 Form

510(k) Number (if known): K121433

Device Name: GoodLife CS-200 Blood Glucose Monitoring System

Indications for Use:

The GoodLife CS-200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife CS-200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

AND/OR Over-The-Counter Use _ Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

The States of the Comments of the Children Comments on Child African Comments of Child Annual Children Comments of

Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)

Katherine Serrano

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k) K121433

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Indications for Use Form

510(k) Number (if known): K121433

Device Name: GoodLife CS-200 Professional Blood Glucose Monitoring System

Indications for Use:

The GoodLife CS-200 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in venous or arterial whole blood or fresh capillary whole blood drawn from the fingertips. It is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices.

The GoodLife CS-200 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use _ × (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 Devices and Radiologic Health (OIR)

Katherine Serrano

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k) K121433

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.