For single use-
GoodLife AC-300 Blood Glucose Monitoring System
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 for use 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 Glucose Control Solutions are for use with the GoodLife AC-300 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-301 Blood Glucose Monitoring System
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 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.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-301 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-302 Blood Glucose Monitoring System
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 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.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-302 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-303 Blood Glucose Monitoring System
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 Glucose Control Solutions are for use with the GoodLife AC-303 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-304 Blood Glucose Monitoring System
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 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.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-304 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-305 Blood Glucose Monitoring System
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 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.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-305 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

For multiple use-
GoodLife AC-300 Professional Blood Glucose Monitoring System
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 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.
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 Glucose Control Solutions are for use with the GoodLife AC-300 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-301 Professional Blood Glucose Monitoring System
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 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.
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 Glucose Control Solutions are for use with the GoodLife AC-301 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-302 Professional Blood Glucose Monitoring System
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 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.
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 Glucose Control Solutions are for use with the GoodLife AC-302 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-303 Professional Blood Glucose Monitoring System
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 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.
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 Glucose Control Solutions are for use with the GoodLife AC-303 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-304 Professional Blood Glucose Monitoring System
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 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.
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 Glucose Control Solutions are for use with the GoodLife AC-304 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-305 Professional Blood Glucose Monitoring System
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.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-305 Professional Blood Glucose Meter and GoodLife AC Professional 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

GoodLife AC-300~~305 Blood Glucose Monitoring System and GoodLife AC-300~~305 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
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]
GoodLife AC-300~~305 Blood Glucose Monitoring System and GoodLife AC - 300~~305 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) to assess the performance of the GoodLife AC-300~~305 with GoodLife AC Blood Glucose Test strips or AC-300~~305 Professional Blood Glucose monitoring system with AC 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 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.

AI/ML Overview

The document describes several GoodLife AC-300~305 blood glucose monitoring systems and their professional counterparts. The acceptance criteria and the study proving the device meets them are outlined, primarily referring to consistency with ISO 15197:2003.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device claims compliance with ISO 15197:2003. This international standard sets the requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. While the document does not explicitly list the detailed clauses of ISO 15197:2003 as acceptance criteria, it states that the device is "compliant to the standard" and that "the results demonstrated that the predetermined acceptance criteria were fully met."

Therefore, the acceptance criteria are implicitly those defined by ISO 15197:2003. The document does not provide specific numerical performance metrics from the study to directly compare against these criteria.

Acceptance Criteria (from ISO 15197:2003 - implied)	Reported Device Performance
Accuracy Requirements (e.g., within ±15% or ±20% of a reference method for specified glucose concentrations)	"fully met" the predetermined acceptance criteria.
Precision Requirements (e.g., coefficient of variation)	Study conducted according to CLSI/NCCLS EP05-A2: Evaluation of Precision Performance of Quantitative Measurement Methods
Linearity (range)	Study conducted according to CLSI EP06-A: Evaluation of the Linearity of Quantitative Measurement. Tested range: 20~600 mg/dL
Interference effects	Study conducted according to CLSI EP07-A2: Interference Testing in Clinical Chemistry
Method comparison	Study conducted according to CLSI/NCCLS EP09-A2: Method Comparison and Bias Estimation Using Patient Samples
Other requirements of ISO 15197:2003	"fully met" the predetermined acceptance criteria.

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

The document 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 specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The studies cited (CLSI/NCCLS EP05-A2, EP06-A, EP07-A2, EP09-A2) are guidelines for evaluating the performance of quantitative measurement methods, implying that an established reference method (often laboratory-based) would serve as the ground truth.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. For quantitative measurements like blood glucose, adjudication among multiple human readers is typically not applicable in the same way it would be for qualitative assessments (e.g., image interpretation). Instead, the device's readings are compared against a reference method.

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

No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging or subjective assessments where multiple human readers interpret cases. Blood glucose monitoring systems are quantitative measurement devices not typically evaluated with MRMC studies in this context. Therefore, there is no effect size of human readers improving with AI vs. without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The performance described for the blood glucose monitoring system is inherently a standalone performance. The device provides a quantitative measurement of glucose. A "human-in-the-loop" would involve interpretation or decision-making aided by the device's output, but the device's core function is the measurement itself. The studies performed (e.g., accuracy, precision, linearity) evaluate this standalone measurement capability. Therefore, yes, a standalone performance evaluation was done.

7. The Type of Ground Truth Used

Based on the nature of blood glucose monitoring and the CLSI standards referenced, the ground truth would typically be established by a highly accurate laboratory reference method for glucose measurement. The document states a "reference method" is used, which is standard practice in these types of evaluations. The CLSI/NCCLS EP09-A2 standard explicitly deals with "Method Comparison and Bias Estimation Using Patient Samples," which involves comparing the device's results to a more established, accurate method.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set. Blood glucose meters are calibrated implicitly during the manufacturing process and through quality control rather than through an "AI training set" in the conventional sense of machine learning algorithms. The calibration involves applying a formula that includes a code parameter specific to the test strip.

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

The device is calibrated by an "implicit coding process" that occurs when a test strip is inserted. This suggests a pre-programmed calibration based on manufacturing specifications and quality control data rather than a dynamic ground truth established for a "training set" in the machine learning context. The document does not detail how the ground truth for this initial calibration was established, but it would typically involve rigorous laboratory testing against reference methods during the device and strip development and manufacturing stages.

Summary

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

K113307

510(k) Summary

JUL 2 7 2012

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:	July 10, 2012

2. Name of Device

Trade/Proprietary Name:

For single patient use-

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

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

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

Common name: Classification name: Classification Panel: Requlation no.: Product code:

Blood Glucose Test System Glucose Test System Clinical Chemistry (75) 862.1345 (Class II), 862.1660 (Class I) NBW, LFR, JJX

1. Predicate Device Trade/Proprietary name: Common name:
  Submitter:

510(k) no.:

Product code:

U-RIGHT TD-4279A Blood Glucose Monitoring System Blood Glucose Test System TaiDoc Technology Corporation K101509 nbw, LFR

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

4. Device Description

GoodLife AC-300~~305 Blood Glucose Monitoring System and GoodLife AC-300~~305 Professional Blood Glucose Monitoring System consist of:

(1)Glucose Meter

(2)Glucose Test Strips

(3) Two levels of qlucose 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

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

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]

GoodLife AC-300~~305 Blood Glucose Monitoring System and GoodLife AC - 300~~305 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) to assess the performance of the GoodLife AC-300~~305 with GoodLife AC Blood Glucose Test strips or AC-300~~305 Professional Blood Glucose monitoring system with AC 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 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.

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

5. Intended Use

For single use-

GoodLife AC-300 Blood Glucose Monitoring System

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 for use 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 Glucose Control Solutions are for use with the GoodLife AC-300 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-301 Blood Glucose Monitoring System

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

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

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-301 Blood Glucose Meter to quantitatively measure qlucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

The GoodLife Glucose Control Solutions are for use with the GoodLife AC-301 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-302 Blood Glucose Monitoring System

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 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.

The GoodLife Glucose Control Solutions are for use with the GoodLife AC-302 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-303 Blood Glucose Monitoring System

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

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 Glucose Control Solutions are for use with the GoodLife AC-303 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-304 Blood Glucose Monitoring System

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.

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

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.

The GoodLife Glucose Control Solutions are for use with the GoodLife AC-304 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-305 Blood Glucose Monitoring System

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 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.

The GoodLife Glucose Control Solutions are for use with the GoodLife AC-305 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

For multiple use-

GoodLife AC-300 Professional Blood Glucose Monitoring System

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

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 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.

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 Glucose Control Solutions are for use with the GoodLife AC-300 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-301 Professional Blood Glucose Monitoring System

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.

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

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 Glucose Control Solutions are for use with the GoodLife AC-301 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-302 Professional Blood Glucose Monitoring System

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 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.

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 Glucose Control Solutions are for use with the GoodLife AC-302 Professional Blood Glucose Meter and GoodLife

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

AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-303 Professional Blood Glucose Monitoring System

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 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.

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 Glucose Control Solutions are for use with the GoodLife AC-303 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-304 Professional Blood Glucose Monitoring System

The GoodLife AC-304 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of qlucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-304 Professional Blood

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

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 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.

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 Glucose Control Solutions are for use with the GoodLife AC-304 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-305 Professional Blood Glucose Monitoring System

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.

e-11

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

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.

The GoodLife Glucose Control Solutions are for use with the GoodLife AC-305 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

6. Comparison of Subject Devices and predicate device

Technological Characteristics Comparison Table of GoodLife AC-300~~305 & AC-300~~305 Professional Blood Glucose Monitoring System and U-RIGHT TD-4279A Blood Glucose Monitoring System (K101509)

Item	Subject Device	Predicate Device
	GoodLife AC-300~~305 &AC-300~~305 Professional BGMSU-RIGHT TD-4279A BGMS
	Similarities
Intended use	It is designed to quantitativelymeasure the concentration ofglucose in fresh capillary wholeblood	Same
Detection method	Amperometry:Current produced by chemicalreaction	Same
Test range	20~600mg/dL	Same
Operatingconditions	50~~104°F (10~~40°C)	Same
Test time	5 sec	Same
Capillary testingsite	Fingertips only	Same

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Enzyme	Glucose Dehydrogenase (FAD)	Same
Intended use	It is designed to quantitativelymeasure the concentration ofglucose in fresh capillary wholeblood	Same
Differences
Coding function	Coding function is combined ineach test strip. Coding will bedone when insert the test strip toperform the glucose test.	By code strip
Sample volume	0.5ul	1.1ul
Storage condition	50~~104°F (10~~40°C)	35.6~~89.6°F(2~~32°C)
PC datatransmission	N/A	USB cable

Discussion of Clinical Tests Performed

GoodLife AC-300~~305 & AC-300~~305 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.

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:
(1) ISO 15197:2003 In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

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

(2) IEC/EN 60601-1:2005 + CORR. 1(2006) + CORR. 2(2007), EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- 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
- CLSI EP06-A: Evaluation of the Linearity of Quantitative (5) 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 .

9. 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.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/14/Picture/2 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 human figure.

HMD BioMedical Inc c/o Jessica Tung No. 181, Minsheng St Xinou Township. Hsinchu County 305, Taiwan 10903 New Hampshire Avenue Silver Spring, MD 20993

JUL 2 7 2012

Re: K113307

Trade 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: Class II Product Codes: NBW, LFR, JJX Dated: July 20, 2012 Received: July 23, 2012

Dear Ms Tung:

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 the Federal Food, Drag, Drag, therefore, market the device, subject to the general approvisions 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 such additional controls. Existing major regulations affecting (1 writ), it may of casyott in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. your device can oo loand further announcements concerning your device in the Eederal 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 mount that I Dr may may statutes and regulations administered by other Federal agencies. of the Act of any I outh the Act's requirements, including, but not limited to: registration

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

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device -Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): __k113307

Device Name [Trade Name]:

GoodLife AC-300 Blood Glucose Monitoring System

Indications for Use:

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

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

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

Signature

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

210(k)

Page 1 of _12

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

510(k) Number (if known): ___k113307

Device Name [Trade Name]:

GoodLife AC-301 Blood Glucose Monitoring System

Indications for Use:

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.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

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

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

CARS

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K11330 |

Page Lof 12

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

510(k) Number (if known): ___k113307

Device Name [Trade Name]:

GoodLife AC-302 Blood Glucose Monitoring System

Indications for Use:

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

Over-The-Counter Use ___V Prescription 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)

signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety · 510(k) K 1133 0 )

Page 3 of _12

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

510(k) Number (if known): ___k113307

Device Name [Trade Name]:

GoodLife AC-303 Blood Glucose Monitoring System

Indications for Use:

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

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

COORS

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

510(k) K11330/

Page & of _12

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

510(k) Number (if known): __k113307

Device Name [Trade Name]:

GoodLife AC-304 Blood Glucose Monitoring System

Indications for Use:

Over-The-Counter Use _ V Prescription 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)

GOWAS

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 200(K)

Page Lot 12

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

510(k) Number (if known): __k113307

Device Name [Trade Name]:

GoodLife AC-305 Blood Glucose Monitoring System

Indications for Use:

Over-The-Counter Use _ V Prescription 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)

GORS

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) - K1133 o

Page 6 of 12

{22}------------------------------------------------

510(k) Number (if known): __ K113307

Device Name [Trade Name]:

GoodLife AC-300 Professional Blood Glucose Monitoring System

Indications for Use:

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.

Over-The-Counter Use V Prescription 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)

signature

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

510(k) K113307

{23}------------------------------------------------

510(k) Number (if known): ___k113307

Device Name [Trade Name]:

GoodLife AC-301 Professional Blood Glucose Monitoring System

Indications for Use:

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.

Over-The-Counter Use _V Prescription Use _ V 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)

GDS

Division Sign-Off

Office of In Vitro Diagnostic Device

Evaluation and Safety

510(k) K113307

Page & of 12

{24}------------------------------------------------

510(k) Number (if known): ___k113307

Device Name [Trade Name]:

GoodLife AC-302 Professional Blood Glucose Monitoring System

Indications for Use:

The GoodLife Glucose Control Solutions are for use with the GoodLife AC-302 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

Prescription Use __ V (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _V AND/OR (21 CFR 801 Subpart C)

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

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

GWS

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

210(K)

Page of 12

{25}------------------------------------------------

510(k) Number (if known): __k113307

Device Name [Trade Name]:

GoodLife AC-303 Professional Blood Glucose Monitoring System

Indications for Use:

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.

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription 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)

signature

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

510(k) K113307

Page 10of 12

{26}------------------------------------------------

510(k) Number (if known): ___k113307

Device Name {Trade Name]:

GoodLife AC-304 Professional Blood Glucose Monitoring System

Indications for Use:

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.

Over-The-Counter Use __V Prescription Use __ V 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)

signature

Division Sign-Off Office of In Vitro Diagnostic Device

Evaluation and Safety

510(k) k11330/

Page 1lof_12_

{27}------------------------------------------------

510(k) Number (if known): ___k113307

Device Name [Trade Name]:

GoodLife AC-305 Professional Blood Glucose Monitoring System

Indications for Use:

Prescription Use ___ V (Part 21 CFR 801 Subpart D)

Over-The-Counter Use V AND/OR (21 CFR 801 Subpart C)

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

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

Signature

Division Sign-Off Office of In Vitro Diagnostic Device

Evaluation and Safety

510(k) K11330/

Page 12of 12

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.