(262 days)
No
The description focuses on the electrochemical biosensor technology and standard calibration methods, with no mention of AI or ML.
No.
The device is a blood glucose monitoring system, which is intended for diagnostic use to monitor blood glucose levels, not to provide therapy.
Yes.
Explanation: The device is explicitly stated as being an "in vitro diagnostic use" device, intended to aid in monitoring the effectiveness of diabetes control. While it states it should "not be used for the diagnosis of or screening of diabetes," its function for monitoring diabetes control falls under a diagnostic aid.
No
The device description explicitly states that the system consists of a Glucose Meter, Glucose Test Strips, and other physical components like control solutions and a check strip. This indicates it is a hardware-based system with associated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The intended use section for both the single-use and multiple-use systems explicitly states: "The GoodLife AC-300
305 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use)..." and "The GoodLife AC-300305 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use)...". - Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device measures glucose in a blood sample taken from the fingertip, which fits this definition.
- Purpose: The device is used to quantitatively measure glucose in blood, which is a diagnostic measurement used to monitor diabetes control.
Therefore, based on the provided information, the GoodLife AC-300305 Blood Glucose Monitoring System and the GoodLife AC-300305 Professional Blood Glucose Monitoring System are indeed IVD devices.
N/A
Intended Use / Indications for 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 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
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 qlucose (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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR, JJX
Device Description
GoodLife AC-300305 Blood Glucose Monitoring System and GoodLife AC-300305 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
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-300305 Blood Glucose Monitoring System and GoodLife AC - 300305 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-300305 with GoodLife AC Blood Glucose Test strips or AC-300305 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips
Indicated Patient Age Range
The GoodLife AC-300 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
Intended User / Care Setting
For single patient use - people with diabetes at home.
For multiple patient use - a health care professional in a clinical setting / healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
(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
(3) IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility- Requirements and tests
(4) CLSI/NCCLS EP05-A2: Evaluation of Precision Performance of Quantitative Measurement Methods
(5) CLSI EP06-A: Evaluation of the Linearity of Quantitative Measurement.
(6) CLSI EP07-A2: Interference Testing in Clinical Chemistry
(7) CLSI/NCCLS EP09-A2: Method Comparison and Bias Estimation Using Patient Samples
(8) FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11 2005.
GoodLife AC-300305 & AC-300305 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary
JUL 2 7 2012
| Company name: | HMD BioMedical Inc. |
|---|---|
| Contact person: | Jessica Tung |
| Address: | No. 181, Minsheng St., Xinpu Township, Hsinchu |
| County, Taiwan | |
| Phone: | 886-3-6017000 |
| FAX: | 886-3-5885500 |
| E-mail: | jessica-tung@hmdbio.com |
| Date Prepared: | 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
-
- Predicate Device Trade/Proprietary name: Common name:
Submitter:
- Predicate Device Trade/Proprietary name: Common name:
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-300305 Blood Glucose Monitoring System and GoodLife AC-300305 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-300305 Blood Glucose Monitoring System and GoodLife AC - 300305 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-300305 with GoodLife AC Blood Glucose Test strips or AC-300305 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.
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
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-300305 & AC-300305 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 BGMS | ||
| U-RIGHT TD-4279A BGMS | ||
| Similarities | ||
| Intended use | It is designed to quantitatively | |
| measure the concentration of | ||
| glucose in fresh capillary whole | ||
| blood | Same | |
| Detection method | Amperometry: | |
| Current produced by chemical | ||
| reaction | Same | |
| Test range | 20~600mg/dL | Same |
| Operating | ||
| conditions | 50 | Same |
| Test time | 5 sec | Same |
| Capillary testing | ||
| site | Fingertips only | Same |
12
| Enzyme | Glucose Dehydrogenase (FAD) | Same |
|---|---|---|
| Intended use | It is designed to quantitatively | |
| measure the concentration of | ||
| glucose in fresh capillary whole | ||
| blood | Same | |
| Differences | ||
| Coding function | Coding function is combined in | |
| each test strip. Coding will be | ||
| done when insert the test strip to | ||
| perform the glucose test. | By code strip | |
| Sample volume | 0.5ul | 1.1ul |
| Storage condition | 50 | 35.6 |
| PC data | ||
| transmission | N/A | USB cable |
Discussion of Clinical Tests Performed
GoodLife AC-300305 & AC-300305 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.
-
- 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:
- Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
-
(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.
Ci
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
16
510(k) Number (if known): __k113307
Device Name [Trade Name]:
GoodLife AC-300 Blood Glucose Monitoring System
Indications for Use:
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.
| 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-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.
| 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-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 J 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.
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:
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.
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:
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.
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:
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.
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 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.
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 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.
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 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.
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 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.
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.
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.
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:
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.
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/
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