The GoodLife AC-300 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 AC-300 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.

The GoodLife AC-300 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 AC-300 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The GoodLife AC Blood Glucose Test Strips are with the GoodLife AC-300 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

The GoodLife AC-301 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 AC-301 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.

The GoodLife AC-301 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 AC-301 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The GoodLife AC Blood Glucose Test Strips are with the GoodLife AC-301 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

The GoodLife AC-302 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 AC-302 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.

The GoodLife AC-302 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 AC-302 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The GoodLife AC Blood Glucose Test Strips are with the GoodLife AC-302 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

The GoodLife AC-303 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 AC-303 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.

The GoodLife AC-303 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 AC-303 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-303 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

The GoodLife AC-304 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 AC-304 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.

The GoodLife AC-304 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 AC-304 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The GoodLife AC Blood Glucose Test Strips are with the GoodLife AC-304 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

The GoodLife AC-305 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 AC-305 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.

The GoodLife AC-305 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 AC-305 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The GoodLife AC Blood Glucose Test Strips are with the GoodLife AC-305 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

The GoodLife AC-300 Professional 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 AC-300 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.

The GoodLife AC-300 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-300 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The GoodLife AC-301 Professional 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 AC-301 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.

The GoodLife AC-301 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-301 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The GoodLife AC-302 Professional 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 AC-302 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.

The GoodLife AC-302 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-302 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The GoodLife AC-303 Professional 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 AC-303 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.

The GoodLife AC-303 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-303 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The GoodLife AC-304 Professional 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 AC-304 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.

The GoodLife AC-304 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-304 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The GoodLife AC-305 Professional 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 AC-305 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.

The GoodLife AC-305 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 GoodLife AC-305 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-305 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Device Description

GL GoodLife Series Blood Glucose Monitoring System consists of: (1) Glucose Meter (Model no.: AC-300, AC-301, AC-302, AC-303, AC-304, AC-305), (2) Glucose Test Strips (Model no.: AC) prior 510(k) clearance K113307, (3) Two levels of glucose control solutions (L1 and L2) may be purchased separately. prior 510(k) clearance K113307, (4) Check Strip, (5) Instruction for use. GL GoodLife Series Professional Blood Glucose Monitoring System consists of: Glucose Meter (Model no.: AC-300, AC-301, AC-302, AC-303, AC-304, AC-305), (2) Glucose Test Strips (Model no.: AC) prior 510(k) clearance K113307, (3) Two levels of glucose control solutions (L1 and L2) may be purchased separately. prior 510(k) clearance K113307, (4) Check Strip, (5) Instruction for use. These models have the same intended use and technological characteristics except the housing of the meter. Although the different shapes of housing, the materials are the same.

AI/ML Overview

The provided document is a 510(k) summary for the GoodLife AC-300 series Blood Glucose Monitoring Systems. It claims substantial equivalence to a predicate device (K113307) based on meeting performance requirements.

Here's a breakdown of the requested information, extracted from the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria and reported device performance. It only states that the device "met pre-determined acceptance criteria" and "fulfilled the requirements from those standards mentioned above." The exact standards and specific performance metrics (e.g., accuracy percentages per glucose range) are not detailed within this summary.

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

The document mentions "results of testing performed to validate changes to the system met pre-determined acceptance criteria," implying a test set was used, but it does not provide any information regarding the sample size of the test set or the data provenance (country of origin, retrospective/prospective nature).

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)

The document does not provide any information about the number of experts used to establish ground truth or their qualifications. For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods, not subjective expert consensus.

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

The document does not provide any information about an adjudication method for the test set. For objective measurements like blood glucose, adjudication would not typically be applicable in the way it is for image interpretation.

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 is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device that involves human readers. Therefore, an MRMC comparative effectiveness study involving human readers is not applicable and was not performed.

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

Yes, this is a standalone device. The "algorithm" (the electrochemical biosensor system) provides the measurement directly without human subjective interpretation. The document describes it as an electrochemical biosensor system that measures and displays the result directly.

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

While not explicitly stated in this summary, for blood glucose monitoring systems, the ground truth is established by comparison to a recognized laboratory reference method (e.g., a YSI analyzer). The regulatory review for such devices always requires this comparison, and the phrase "met pre-determined acceptance criteria" would implicitly refer to such a comparison.

8. The sample size for the training set

This device is not an AI/machine learning model in the conventional sense that would require a "training set." It is an electrochemical biosensor. Therefore, the concept of a training set is not applicable. The device's performance is determined by its engineering, chemical reagents, and calibration processes.

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

As the concept of a training set is not applicable for this type of device, this information is not relevant. The device's calibration is achieved by an implicit coding process when the test strip is inserted, which incorporates parameters to calculate the glucose value (page 17).

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form, with three figures facing to the right.

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

May 14, 2015

HMD BIOMEDICAL, INC. AXEL LIN QUALITY ASSURANCE MANAGER NO 181 MINSHENG ST, XINPU TOWNSHIP HSINCHU 305, TAIWAN

Re: K140150

Trade/Device Name: Goodlife AC-300 Blood Glucose Monitoring System Goodlife AC-301 Blood Glucose Monitoring System Goodlife AC-302 Blood Glucose Monitoring System Goodlife AC 303 Blood Glucose Monitoring System Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System Goodlife AC-300 Professional Blood Glucose Monitoring System Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-302 Professional Blood Glucose Monitoring System Goodlife AC-303 Professional Blood Glucose Monitoring System Goodlife AC-304 Professional Blood Glucose Monitoring System Goodlife AC-305 Professional Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: April 15, 2015 Received: April 16, 2015

Dear Axel Lin:

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.

{1}------------------------------------------------

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 Parts 801 and 809); medical device reporting (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.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Katherine Serrano -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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K140150

Device Name

GoodLife AC-300 Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

본 Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K140150

Device Name

GoodLife AC-301 Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

본 Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{4}------------------------------------------------

Indications for Use

510(k) Number (if known) K140150

Device Name

GoodLife AC-302 Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

본 Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{5}------------------------------------------------

Indications for Use

510(k) Number (if known) K140150

Device Name

GoodLife AC-303 Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

본 Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{6}------------------------------------------------

Indications for Use

510(k) Number (if known) K140150

Device Name

GoodLife AC-304 Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

본 Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{7}------------------------------------------------

Indications for Use

510(k) Number (if known) K140150

Device Name

GoodLife AC-305 Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

본 Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{8}------------------------------------------------

Indications for Use

510(k) Number (if known) K140150

Device Name

GoodLife AC-300 Professional Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

본 Prescription Use (Part 21 CFR 801 Subpart D)

본 Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{9}------------------------------------------------

Indications for Use

510(k) Number (if known) K140150

Device Name

GoodLife AC-301 Professional Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

본 Prescription Use (Part 21 CFR 801 Subpart D)

본 Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{10}------------------------------------------------

Indications for Use

510(k) Number (if known) K140150

Device Name

GoodLife AC-302 Professional Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

본 Prescription Use (Part 21 CFR 801 Subpart D)

본 Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{11}------------------------------------------------

Indications for Use

510(k) Number (if known) K140150

Device Name

GoodLife AC-303 Professional Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

본 Prescription Use (Part 21 CFR 801 Subpart D)

본 Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{12}------------------------------------------------

Indications for Use

510(k) Number (if known) K140150

Device Name

GoodLife AC-304 Professional Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

본 Prescription Use (Part 21 CFR 801 Subpart D)

본 Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{13}------------------------------------------------

Indications for Use

510(k) Number (if known) K140150

Device Name

GoodLife AC-305 Professional Blood Glucose Monitoring System

Indications for Use (Describe)

The GoodLife AC-305 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

Type of Use (Select one or both, as applicable)

본 Prescription Use (Part 21 CFR 801 Subpart D)

본 Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{14}------------------------------------------------

510(k) Summary

1. Submitter Information

Company name:	HMD BioMedical Inc.
Contact person:	Axel Lin
Address:	No. 181, Minsheng St., Xinpu Township, HsinchuCounty, Taiwan
Phone:	886-3-6017000
FAX:	886-3-5885500
E-mail:	axellin@hmdbio.com
Date Prepared:	MAY 14 2015

2. Name of Device

Trade/Proprietary Name:

For single patient use-

For multiple patient use-

GoodLife AC-300 Professional Blood Glucose Monitoring System GoodLife AC-301 Professional Blood Glucose Monitoring System GoodLife AC-302 Professional Blood Glucose Monitoring System GoodLife AC-303 Professional Blood Glucose Monitoring System GoodLife AC-304 Professional Blood Glucose Monitoring System GoodLife AC-305 Professional Blood Glucose Monitoring System

{15}------------------------------------------------

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:	NBW, LFR

3. Predicate Device

Trade/Proprietary name:

GoodLife AC-300 Blood Glucose Monitoring System GoodLife AC-301 Blood Glucose Monitoring System GoodLife AC-302 Blood Glucose Monitoring System GoodLife AC-303 Blood Glucose Monitoring System GoodLife AC-304 Blood Glucose Monitoring System GoodLife AC-305 Blood Glucose Monitoring System GoodLife AC-300 Professional Blood Glucose Monitoring System GoodLife AC-301 Professional Blood Glucose Monitoring System GoodLife AC-302 Professional Blood Glucose Monitoring System GoodLife AC-303 Professional Blood Glucose Monitoring System GoodLife AC-304 Professional Blood Glucose Monitoring System GoodLife AC-305 Professional Blood Glucose Monitoring System Rlood Cluce Test Svste

Common name:	Blood Glucose Test System
Submitter:	HMD BioMedical Inc.
510(k) no.:	K113307
Product code:	LFR, NBW, JJX

1. Device Description
  The device description of the GL GoodLife Series Blood Glucose Monitoring System is as follows.

GL GoodLife Series Blood Glucose Monitoring System consists of:

{16}------------------------------------------------

(1) Glucose Meter (Model no.: AC-300, AC-301, AC-302, AC-303, AC-304, AC-305)

(2) Glucose Test Strips (Model no.: AC) prior 510(k) clearance K113307

(3) Two levels of glucose control solutions (L1 and L2) may be purchased separately. prior 510(k) clearance K113307

(4) Check Strip

(5) Instruction for use

GL GoodLife Series Professional Blood Glucose Monitoring System consists of:

Glucose Meter (Model no.: AC-300, AC-301, AC-302, AC-303, (1) AC-304, AC-305)

(2) Glucose Test Strips (Model no.: AC) prior 510(k) clearance K113307

(3) Two levels of glucose control solutions (L1 and L2) may be purchased separately. prior 510(k) clearance K113307

(4) Check Strip
(5) Instruction for use

These models have the same intended use and technological characteristics except the housing of the meter. Although the different shapes of housing, the materials are the same.

[Test Principle]

GL GoodLife Series Blood Glucose Monitoring System is an 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.

{17}------------------------------------------------

[Control Solution]

The GL GoodLife Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) assessing the performance of the GL GoodLife Series Blood Glucose monitoring system and GoodLife Blood Glucose Test strips (AC). There are two levels of controls (L1 and L2).

[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. While inserting the test strip into strip slot to perform the blood glucose test, the coding procedure is complete. The meter will apply formula including this parameter of code to calculate the glucose value.

5. Intended Use

For single patient use:

GoodLife AC-300 Blood Glucose Monitoring System

The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-300 Blood Glucose Meter to quantitatively measure

{18}------------------------------------------------

glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

GoodLife AC-301 Blood Glucose Monitoring System

The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-301 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

GoodLife AC-302 Blood Glucose Monitoring System

{19}------------------------------------------------

The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-302 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

GoodLife AC-303 Blood Glucose Monitoring System

GoodLife AC-304 Blood Glucose Monitoring System

{20}------------------------------------------------

System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-304 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

GoodLife AC-305 Blood Glucose Monitoring System

The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-305 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

For multiple use-

GoodLife AC-300 Professional Blood Glucose Monitoring System

{21}------------------------------------------------

Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.

The GoodLife AC-300 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 GoodLife AC-300 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

GoodLife AC-301 Professional Blood Glucose Monitoring System

The GoodLife AC-301 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 GoodLife AC-301 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

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GoodLife AC-302 Professional Blood Glucose Monitoring System

The GoodLife AC-302 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 GoodLife AC-302 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

GoodLife AC-303 Professional Blood Glucose Monitoring System

The GoodLife AC-303 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 GoodLife AC-303 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

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GoodLife AC-304 Professional Blood Glucose Monitoring System

The GoodLife AC-304 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 GoodLife AC-304 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

GoodLife AC-305 Professional Blood Glucose Monitoring System

The GoodLife AC-305 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

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to monitor the effectiveness of diabetes control. The GoodLife AC-305 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

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1. Comparison of Subject Devices and predicate device
  Technological Characteristics Comparison Table of GL GoodLife Series Blood Glucose Monitoring System (K113307)

Similarities
Item	Subject device	Predicate device
	GL GoodLife Series BGMS	GL GoodLife SeriesBGMS (K113307)
Intended use	It is designed to quantitatively measure theconcentration of glucose in fresh capillary wholeblood.	Same
Detectionmethod	Amperometry: Current produced by chemicalreaction	Same
Test range	20~600mg/dL	Same
Operatingconditions	50~~104°F (10~~40°C), 20~80%	Same
StorageTemperature	50~~104°F (10~~40°C), 20~80%	Same
Autocoding	Yes	Same
Enzyme	Glucose Dehydrogenase (FAD) (Aspergillusoryzae)	Same
Capillarytesting site	Fingertips only	Same
Samplevolume	0.5ul	Same
Memory	999	Same
Test time	5 sec	Same
Average	30 days	Same
Codingfunction	Coding function is combined in each test strip.Coding will be done when insert the test strip to	Same
Similarities
Item	Subject device	Predicate device
	GL GoodLife Series BGMS	GL GoodLife SeriesBGMS (K113307)
	perform the glucose test.

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Differences
Item	Subject device	Predicate device
	GL GoodLife Series	GL GoodLife Series (K113307)
Datatransmission	Near Field Communication (NFC)module (Dynamic NFC Tag)	N/A
S/N Label ofMeter	With NFC logo	Without NFC logo
Bag size andthe label sizeof foil packedstrip	Adding different packing formats for15 pcs, 100 pcs/each bag	Only one format for 50 pcs/eachbag
Contents of foilpacked strip	15 pcs, 50 pcs, 100 pcs/each bag	Only 50 pcs/each bag

7. Discussion of Clinical Tests Performed

GL GoodLife Series Blood Glucose Monitoring System (Subject Device) results of testing performed to validate changes to the system met pre-determined acceptance criteria and demonstrate that the subject device is substantially equivalent to the predicate device.

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.

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.