(344 days)
Not Found
No
The description focuses on data transfer, storage, analysis, and communication of historical blood glucose data, which are standard data management functions and do not inherently involve AI/ML. There is no mention of AI, ML, or related concepts in the provided text.
No
The device, whether it's the software or the blood glucose monitoring systems, is intended for measurement and data management of blood glucose levels to aid in monitoring diabetes control. It explicitly states it is "not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment," which aligns with a diagnostic or monitoring function rather than a therapeutic one.
Yes
The AG-608 MULTI Blood Glucose Monitoring System and AG-608 Single Blood Glucose Monitoring System, which the software works with, are explicitly stated to be for the "quantitative measurement of glucose (sugar) in fresh capillary whole blood samples," which is a diagnostic function. The text also states that they are "an aid in monitoring the effectiveness of diabetes control." Although they are not for the diagnosis of diabetes, the monitoring of blood glucose levels for disease management is a diagnostic activity.
Yes
The device description explicitly states "Andon Health Care Management System Software is an optional software accessory" and describes its function as transferring data from blood glucose meters to a computer for data management. It does not include any hardware components.
Based on the provided text, here's the breakdown of whether each component is an IVD:
-
Andon Health Care Management System Software: No, the software itself is not an IVD. Its intended use is for data management, analysis, and communication of blood glucose results obtained from IVD devices. It does not perform the diagnostic test itself.
-
AG-608 MULTI Blood Glucose Monitoring System: Yes, this is an IVD. The intended use explicitly states it is for the "quantitative measurement of glucose (sugar) in fresh capillary whole blood samples" and is for "in vitro diagnostic use".
-
AGS-1000 MULTI Blood Glucose Test Strips: Yes, these are IVD components. They are used with the AG-608 MULTI meter to perform the quantitative measurement of glucose in blood samples, which is an in vitro diagnostic process.
-
AG-608 Single Blood Glucose Monitoring System: Yes, this is an IVD. The intended use explicitly states it is for the "quantitative measurement of glucose (sugar) in fresh capillary whole blood samples" and is for "self testing outside the body (in vitro diagnostic use)".
-
AGS-1000 Single Blood Glucose Test Strips: Yes, these are IVD components. They are used with the AG-608 Single meter to perform the quantitative measurement of glucose in blood samples, which is an in vitro diagnostic process.
In summary: The blood glucose meters and the test strips are IVD devices/components. The software is an accessory for data management and is not an IVD itself.
N/A
Intended Use / Indications for Use
Andon Health Care Management System Software is an optional software accessory for use with the Andon blood glucose meters with data management capacities, When used with one of these meters, Andon Health Care Management System Software transfers data from the device's memory into a computer for enhanced data management.
Andon Health Care Management System Software is intended for use in home and clinical settings via the internet to assist people with diabetes and their healthcare professionals in uploading, storing, analyzing, and communicating historical blood glucose test results and other biological statistics to support diabetes management. Andon Heath Care System Software is not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
The AG-608 MULTI 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. The AG-608 MULTI Blood Glucose Monitoring System is intended to be used by healthcare professionals for multiple patients in a professional healthcare setting as an aid in monitoring the effectiveness of diabetes control.
The AG-608 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-608 MULT1 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.
This system should only be used with single-use, auto-disabling lancing devices.
The AG-608 Single 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. The AG-608 Single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The AG-608 Single 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 AG-608 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
The AGS-1000 Single Blood Glucose Test Strips are for use with the AG-608 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.
Product codes (comma separated list FDA assigned to the subject device)
NBW, JQP
Device Description
Andon Health Care Management System Software is an optional software accessory for use with AG-608 Single Blood Glucose Monitoring System and AG-608 Multi Blood Glucose Monitoring System. When used with AG-608 Single Blood Glucose Monitoring System and AG-608 Multi Blood Glucose Monitoring System, Andon Health Care Management System Software transfers data from the device's memory into a computer for enhanced data management.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home and clinical settings
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
Testing of Andon Health Care Management System Software included system test and unit test.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
510(k) Summary
AUG 26 2011
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.
1.0 submitter's information
Andon Medical Co., Ltd. Name: No.04-23-3 AIRPORT INDUSTRIAL PARK, TIANJIN Address: Phone number: 86-22-8761 2426 Fax number: 86-22-6052 6162 Contact: Yi Liu Date of Application: 9/10/2010
2.0 Device information
| Trade name: | Andon Health Care Management System Software |
|---|---|
| Common name: | Data management software |
| Classification name: | Data management software |
3.0 Classification
Production code: NBW- Blood Glucose Monitoring System. Requlation number: 862.1345 Classification: II Panel: Clinical Chemistry
4.0 Predict device information
Manufacturer: Taidoc Technology Corporation Device: Clever Chek Health Care System Software 510(k) number: K070941
5.0 Device description
Andon Health Care Management System Software is an optional software accessory for use with AG-608 Single Blood Glucose Monitoring System and AG-608 Multi Blood Glucose Monitoring System. When used with AG-608 Single Blood Glucose Monitoring System and AG-608 Multi Blood Glucose Monitoring System, Andon Health Care Management System Software transfers data from the device's memory into a computer for enhanced data management.
1
6.0 Intended use
Andon Health Care Management System Software is an optional software accessory for use with the Andon blood glucose meters with data management capacities, When used with one of these meters, Andon Health Care Management System Software transfers data from the device's memory into a computer for enhanced data management. Andon Health Care Management System Software is intended for use in home and clinical settings via the internet to assist people with diabetes and their healthcare professionals in uploading, storing, analyzing, and communicating historical blood glucose test results and other biological statistics to support diabetes management. Andon Heath Care System Software is not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
The AG-608 MULTI 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. The AG-608 MULTI Blood Glucose Monitoring System is intended to be used by healthcare professionals for multiple patients in a professional healthcare setting as an aid in monitoring the effectiveness of diabetes control.
The AG-608 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-608 MULT1 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.
This system should only be used with single-use, auto-disabling lancing devices.
The AG-608 Single 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. The AG-608 Single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
2
The AG-608 Single 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 AG-608 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
The AGS-1000 Single Blood Glucose Test Strips are for use with the AG-608 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.
| item | Andon | Clever |
|---|---|---|
| Indications for use | The ANDON Health Care | |
| Management System | ||
| Software is intended for use | ||
| in | ||
| home and clinical settings as | ||
| an aid for people with users | ||
| and their health | ||
| care professionals to review, | ||
| analyze and evaluate the | ||
| historical test results | ||
| to support health | ||
| management effectively. | The CLEVER CHEK Health | |
| Care System Software is | ||
| intended for use in | ||
| home and clinical settings as | ||
| an aid for people with users | ||
| and their health | ||
| care professionals to review, | ||
| analyze and evaluate the | ||
| historical test results | ||
| to support health | ||
| management effectively. | ||
| Installation method | Exe file | Exe file |
| Package Contents | N/A | N/A |
| Capable of deleting results | Delete all results in meter | Delete all results in meter |
| Language capabilities | English, Spanish | English, Spanish, Traditional |
| Chinese | ||
| Customizable schedule | N/A | N/A |
| Types of graphs etc. | Coordinates graph | Coordinates graph |
| Auto-detect COM port | Yes | Yes |
| System components | PC, USB cable, meter | PC, USB cable, meter |
| Software platform | Microsoft | Windows XP, Windows |
| Vista, Windows 7 | ||
| Hardware requirements | CPU: optimal at 1,2 GHz+ | Personal computer with 400 |
| megahertz (MHz) or higher |
7.0 Summary comparing technological characteristics with predicate device
3
| 256 MB+ RAM | processor clock | |
|---|---|---|
| Disk space: optimal 200 | speed recommended; the | |
| MB+ free space - at least 100 | software does not run on | |
| MB | Apple computers. | |
| Graphic resolution starting | Random access memory | |
| from 1024 x 768, CD-ROM | (RAM) of 64 megabytes | |
| drive, USB interface | (MB) or more | |
| Available hard disk space of | ||
| 30 MB for running the | ||
| program. | ||
| Monitor with 1024 x 768 or | ||
| higher resolution. | ||
| Technology | Visual Basic | Visual Basic |
| Performance specifications, | ||
| including any testing | Read memories in meter. | Read memories in meter. |
| Delete all memories in meter | Delete all memories in meter | |
| Set time to meter | Set time to meter | |
| Draw table and graph | Draw table and graph | |
| Set the personal information | Set the personal information |
.
.
4
8.0 Performance summary
Testing of Andon Health Care Management System Software included system test and unit test.
9.0 Comparison to the predict device and the conclusion
Andon Health Care Management System Software is very similar with the predicted device
Clever Chek Health Care System Software, However, they are intended to use together with the different meters, their port are also different.
However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Andon Medical Co., Ltd c/o Mr. Yi Liu 1st Floor Building C No.3 Jin Ping Street
Nankai District Tianjin, China 300190 Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
AUG 2 6 2001
Re: K102678
R
Trade name: Andon Health Care Management System Software AG-608 Single Blood Glucose Monitoring System AG-608 Multi Blood Glucose Monitoring System
Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, JQP Dated: August 2, 2010 Received: August 2, 2010
Dear Mr. Liu:
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.
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 your device can be found in Title 21. Code of Federal Regulations (CFR). Parts 800 to 895. 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 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).
Image /page/5/Picture/14 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The eagle is composed of three curved lines that suggest feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The text is in all caps and is evenly spaced around the circle.
6
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Andon Health Care Management System Software FDA 510(k) Files
Indication for Use
510(k) Number (if known):
Device Name: Andon Health Care Management System Software
Indication For Use:
Andon Health Care Management System Software is an optional software accessory for use with the Andon blood glucose meters with data management capacities, When used with one of these meters, Andon Health Care Management System Software transfers data from the device's memory into a computer for enhanced data management.
Andon Health Care Management System Software is intended for use in home and clinical settings via the internet to assist people with diabetes and their healthcare professionals in uploading, storing, analyzing, and communicating historical blood glucose test results and other biological statistics to support diabetes management. Andon Heath Care System Software is not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
Prescription Use Yes (21 CFR Part 801 Subpart D) Over the Counter Use Yes (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Rute Chesler
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102678
Page 1 of 3
8
AG-608 Blood Glucose Monitoring System FDA 510(k) Files
Indication for Use
510(k) Number (if known):
Device Name: AG-608 MULTI Blood Glucose Monitoring System
Indication For Use:
The AG-608 MULTI 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. The AG-608 MULTI Blood Glucose Monitoring System is intended to be used by healthcare professionals for multiple patients in a professional healthcare setting as an aid in monitoring the effectiveness of diabetes control.
The AG-608 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-608 MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.
This system should only be used with single-use, auto-disabling lancing devices.
Prescription Use J (21 CFR Part 801 Subpart D)
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Autle C. Hesler
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102678
Page 2 of 3
9
AG-608 Blood Glucose Monitoring System FDA 510(k) Files
Indication for Use
K102678 510(k) Number (if known):
Device Name: AG-608 Single Blood Glucose Monitoring System
Indication For Use:
The AG-608 Single 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. The AG-608 Single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The AG-608 Single 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 AG-608 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
The AGS-1000 Single Blood Glucose Test Strips are for use with the AG-608 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.
And/Or
Prescription Use (21 CFR Part 801 Subpart D) Over the Counter Use √ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Rute Chaler
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)
Page 3 of 3