(276 days)
Not Found
No
The device description details a standard electrochemical biosensor system for measuring glucose. There is no mention of AI or ML in the intended use, device description, or performance studies. The calibration method is based on a digital code strip and a formula, not a learning algorithm.
No
The device is a blood glucose monitoring system, intended for measurement and monitoring, not for direct treatment or therapy. It aids in managing diabetes but does not provide therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states "The GoodLife CS-200 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use)" and "The GoodLife CS-200 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use)". An in vitro diagnostic (IVD) device is a type of diagnostic device.
No
The device description explicitly lists hardware components such as a Glucose Meter, Glucose Test Strips, Control Solutions, and a Check Strip. The test principle also describes an electrochemical biosensor system, which is a hardware-based technology.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The intended use section for both the GoodLife CS-200 and the GoodLife CS-200 Professional explicitly states that the system is intended for "self testing outside the body (in vitro diagnostic use)" and "testing outside the body (in vitro diagnostic use)".
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections. This device measures glucose in blood samples taken from the body.
- Control Solution: The description of the control solution also states it is intended for "in vitro diagnostic use".
Therefore, based on the provided text, the GoodLife CS-200 Blood Glucose Monitoring System and the GoodLife CS-200 Professional Blood Glucose Monitoring System are clearly identified as In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The GoodLife CS-200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife CS-200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The GoodLife CS-200 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GoodLife CS-200 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife KP Blood Glucose Test Strips are for use with the GoodLife CS-200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife CS-200 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in venous or arterial whole blood or fresh capillary whole blood drawn from the fingertips. It is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife CS-200 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife KP Professional Blood Glucose Test Strip is for use with the GoodLife CS-200 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in venous or arterial whole blood or fresh capillary drawn from the fingertips.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR
Device Description
GoodLife CS-200 Blood Glucose Monitoring System and GoodLife CS-200 Professional Blood Glucose Monitoring System consist of:
- (1) Glucose Meter
- (2) Glucose Test Strips
- (3) Two levels of glucose control solutions (Level I and Level II) may be purchased separately. Glucose control solutions were previously cleared under K032985.
- (4) Check Strip
- (5) Instruction for use
Test Principle: The GoodLife CS-200 & GoodLife CS-200 Professional Blood Glucose Monitoring System are electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor. When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use.
Control Solution: The GoodLife Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) assessing the performance of the GoodLife CS-200 & GoodLife CS-200 Professional Blood Glucose Monitoring System and GoodLife KP & GoodLife KP Professional Blood Glucose Test strips. There are two levels of controls (Levels 1, 2).
Check Strip: The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover.
Device Calibration: The device is calibrated by Digital Code Strip. While inserting the Digital Code Strip into the coding slot, the meter will turn on automatically and complete the coding. The meter will apply formula including this parameter of code to calculate the glucose value.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fresh capillary whole blood sample drawn from the fingertips, venous or arterial whole blood
Indicated Patient Age Range
The GoodLife CS-200 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes, nor for neonatal use.
The GoodLife CS-200 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes, nor for neonatal use.
Intended User / Care Setting
GoodLife CS-200 Blood Glucose Monitoring System: single person, self testing outside the body (in vitro diagnostic use) by people with diabetes at home.
GoodLife CS-200 Professional Blood Glucose Monitoring System: multiple-patient use in professional healthcare setting, testing outside the body (in vitro diagnostic use).
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)
GoodLife CS-200 Blood Glucose Monitoring System and GoodLife CS-200 Professional Blood Glucose Monitoring System (Subject Device) is compliant to the standard of ISO 15197:2003 In vitro diagnostic test systems- Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. All the relevant activities were performed by professionals and the results demonstrated that the predetermined acceptance criteria were fully met.
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.
Not Found
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
HMD BioMedical Inc.
510(k) Summary
FEB 1 4 2013
1. Submitter Information
| Company name: | HMD BioMedical Inc. |
|---|---|
| Contact person: | Jessica Tung |
| Address: | No. 181, Minsheng St., Xinpu Township, Hsinchu |
| County, Taiwan | |
| Phone: | 886-3-6017000 |
| FAX: | 886-3-5885500 |
| E-mail: | jessica-tung@hmdbio.com |
| Date Prepared: | February 14, 2013 |
2. Name of Device
Trade/Proprietary Name:
For single patient use
GoodLife CS-200 Blood Glucose Monitoring System
- For multiple patient use
GoodLife CS-200 Professional Blood Glucose Monitoring System
| Common name: | Blood Glucose Test System |
|---|---|
| Classification name: | Glucose Test System |
| Classification Panel: | Clinical Chemistry (75) |
| Regulation no .: | 862.1345 (Class II) |
| Product code: | NBW, LFR |
-
- Predicate Device
| Trade/Proprietary name: | U-RIGHT TD-4279A Blood Glucose
Monitoring System |
|-------------------------|-----------------------------------------------------|
| Common name: | Blood Glucose Test System |
| Submitter: | TaiDoc Technology Corporation |
| 510(k) no.: | K101509 |
| Product code: | NBW, LFR |
- Device Description
1
GoodLife CS-200 Blood Glucose Monitoring System and GoodLife CS-200 Professional Blood Glucose Monitoring System consist of:
- (1) Glucose Meter
- (2) Glucose Test Strips
- (3) Two levels of glucose control solutions (Level I and Level II) may be purchased separately. Glucose control solutions were
- previously cleared under K032985.
- (4) Check Strip
- (5) Instruction for use
[Test Principle]
The GoodLife CS-200 & GoodLife CS-200 Professional Blood Glucose Monitoring System are electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor. When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use.
[Control Solution]
The GoodLife Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) assessing the performance of the GoodLife CS-200 & GoodLife CS-200 Professional Blood Glucose Monitoring System and GoodLife KP & GoodLife KP Professional Blood Glucose Test strips. There are two levels of controls (Levels 1, 2).
[Check Strip]
The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover.
[Device Calibration]
2
HMD BioMedical Inc.
The device is calibrated by Digital Code Strip. While inserting the Digital Code Strip into the coding slot, the meter will turn on automatically and complete the coding. The meter will apply formula including this parameter of code to calculate the glucose value.
5. Intended Use
The GoodLife CS-200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife CS-200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The GoodLife CS-200 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GoodLife CS-200 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes, nor for neonatal use.
The GoodLife KP Blood Glucose Test Strips are for use with the GoodLife CS-200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife CS-200 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in venous or arterial whole blood or fresh capillary whole blood drawn from the fingertips. It is intended for testing outside the body (in vitro diagnostic use) and intended for multiple-patient use in professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife CS-200 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes, nor for neonatal use.
The GoodLife KP Professional Blood Glucose Test Strip is for use with
3
HMD BloMedical Inc.
the GoodLife CS-200 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in venous or arterial whole blood or fresh capillary whole blood drawn from the fingertips
6. Comparison of subject devices and predicate device
Technological Characteristics Comparison Table of GoodLife CS-200 Blood Glucose Monitoring System for single patient use & GoodLife CS-200 Professional Blood Glucose Monitoring System for multiple patient use and U-RIGHT TD-4279A Blood Glucose Monitoring System (K101509)
| Item | Subject Device
GoodLife CS-200 & CS-200 Professional
BGMS | | Predicate Device
U-RIGHT TD-4279A
BGMS (K101509) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------------------------------------------------------------------------------------|
| Similarities | | | |
| Intended use | For single patient use (CS-200) -
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 |
| Coding function | By code strip | | Same |
| Test range | 20600mg/dL | | Same |104°F (10~40°C) | | Same |
| Operating conditions | 50
| Test time | 5 sec | | Same |
| Capillary testing site | For single patient use (CS-200) -
Fingertips only | | Same |
| Enzyme | Glucose Dehydrogenase (FAD) | | Same |
| Differences | | | |
| Intended use | For multiple patient use (CS-200
Professional) -
It is designed to
quantitatively measure the
concentration of glucose in
fresh capillary drawn
from the fingertips, venous or | | It is designed to
quantitatively measure the
concentration of glucose in
fresh capillary whole blood. |
4
HMD BioMedical Inc.
| arterial whole blood samples. | ||
|---|---|---|
| Sample volume | 0.5ul | 1.1ul |
| Storage condition | 50 | 35.6 |
| PC data transmission | N/A | USB cable |
7. Discussion of Clinical Tests Performed
GoodLife CS-200 Blood Glucose Monitoring System and GoodLife CS-200 Professional Blood Glucose Monitoring System (Subject Device) is compliant to the standard of ISO 15197:2003 In vitro diagnostic test systems- Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. All the relevant activities were performed by professionals and the results demonstrated that the predetermined acceptance criteria were fully met.
8. Conclusion
The subject device was tested and fulfilled the requirements from those standards mentioned above, and it's concluded that the subject device is substantially equivalent to the predicate device.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2013
HMD BioMedical Inc. c/o Jessica Tung No. 181. Minsheng St., Xinpu Township, Hsinchu County China (Taiwan) 305
Re: K121433
Trade/Device Name: GoodLife CS-200 Blood Glucose Monitoring System GoodLife CS-200 Professional Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: LFR, NBW Dated: February 07, 2013 Received: February 8, 2013
Dear Ms. Tung:
This letter corrects our substantially equivalent letter of February 14, 2013.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
Indications for Use Form
510(k) Number (if known): K121433
Device Name: GoodLife CS-200 Blood Glucose Monitoring System
Indications for Use:
The GoodLife CS-200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife CS-200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The GoodLife CS-200 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GoodLife CS-200 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife KP Blood Glucose Test Strips are for use with the GoodLife CS-200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
AND/OR Over-The-Counter Use _ Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
The States of the Comments of the Children Comments on Child African Comments of Child Annual Children Comments of
Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)
Katherine Serrano
Division Sign-Off Office of In Vitro Devices and Radiologic Health
510(k) K121433
8
Indications for Use Form
510(k) Number (if known): K121433
Device Name: GoodLife CS-200 Professional Blood Glucose Monitoring System
Indications for Use:
The GoodLife CS-200 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in venous or arterial whole blood or fresh capillary whole blood drawn from the fingertips. It is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife CS-200 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife KP Professional Blood Glucose Test Strip is for use with the GoodLife CS-200 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in venous or arterial whole blood or fresh capillary drawn from the fingertips.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use _ × (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)
Katherine Serrano
Division Sign-Off Office of In Vitro Devices and Radiologic Health
510(k) K121433