(430 days)
No
The description focuses on electrochemical biosensor technology and capillary action for glucose measurement, with no mention of AI or ML.
No
The device is a blood glucose monitoring system, used for quantitative measurement of glucose in blood samples to aid in monitoring diabetes, not for treating or rehabilitating a medical condition.
No.
The text explicitly states: "The AG-607 blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes." and "The AG-607Multi blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes." indicating it is not a diagnostic device.
No
The device description explicitly states that the system consists of a blood glucose meter, test strips, lancets, lancing device, and control solutions, which are all hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The intended use section for both the AG-607 and AG-607Multi 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)".
- Nature of the Test: The device measures glucose in blood samples outside the body, which is the definition of an in vitro diagnostic test.
- Purpose: The purpose is to aid in monitoring the effectiveness of diabetes control, which is a diagnostic purpose performed on a sample taken from the body.
N/A
Intended Use / Indications for Use
The AG-607 blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, calf, or thigh. The AG-607 blood glucose monitoring system is intended to be used by a Single person and should not be shared.
The AG-607 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-607 blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative Site Testing (AST) should be done only during steady-state times (when glucose levels is not changing rapidly).
The EGS-2003 test strips are for use with the AG-607 blood glucose meter to quantitatively measure glucose(sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, calf or thigh.
The AG-607Multi blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The AG-607Multi blood glucose monitoring system is intended for testing outside the body(in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as and aid to monitor the effectiveness of diabetes control program. The system is only used with single-use auto-disabling lancing device.
The AG-607Multi blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative Site Testing (AST) should be done only during steady-state times (when glucose levels is not changing rapidly).
The EGS-2003Multi test strips are for use with the AG-607Multi blood glucose meter to quantitatively measure glucose(sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh.
Product codes
NBW, LFR
Device Description
The AG-607 and AG-607 Multi Glucose Monitoring System (BGMS) consist of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.
They are based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. It uses the same technological characteristics for testing with its predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, palm, forearm, calf, or thigh; fingertips, palm, forearm, upper arm, calf or thigh
Indicated Patient Age Range
Not Found
Intended User / Care Setting
AG-607 Blood Glucose Monitoring System: Single person, self-testing outside the body (in vitro diagnostic use) by people with diabetes at home.
AG-607 Multi Blood Glucose Monitoring System: multiple-patient use in professional healthcare 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical test and the clinical test are done according to the ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping to create a sense of depth.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 16, 2017
ANDON HEALTH CO., LTD YI LIU PRESIDENT NO. 3 JINPING STREET, YA AN ROAD, NANKAI DISTRICT TIANJIN 300190 CHINA
Re: K153561
Trade/Device Name: AG-607 Blood Glucose Monitoring System AG-607 Multi Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: January 20, 2017 Received: January 25, 2017
Dear Yi 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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For: Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153561
Device Name
AG-607 Blood Glucose Monitoring System
Indications for Use (Describe)
The AG-607 blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, calf, or thigh. The AG-607 blood glucose monitoring system is intended to be used by a Single person and should not be shared.
The AG-607 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-607 blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative Site Testing (AST) should be done only during steady-state times (when glucose levels is not changing rapidly).
The EGS-2003 test strips are for use with the AG-607 blood glucose meter to quantitatively measure glucose(sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, calf or thigh.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K153561
Device Name
AG-607 Multi Blood Glucose Monitoring System
Indications for Use (Describe)
The AG-607Multi blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, calf, or thigh. The AG-607Multi blood glucose monitoring system is intended for testing outside the body(in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as and aid to monitor the effectiveness of diabetes control program. The system is only used with single-use auto-disabling lancing device.
The AG-607Multi blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative Site Testing (AST) should be done only during steady-state times (when glucose levels is not changing rapidly).
The EGS-2003 test strips are for use with the AG-607Multi blood glucose meter to quantitatively measure glucose(sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
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
| Name: | Andon Health Co., Ltd. |
|---|---|
| Address: | No.3 Jinping Street,Ya'an Road, Nankai District, Tianjin, |
| P.R. China | |
| Phone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Yi Liu |
| Date of Preparation: | 11/17/2015 |
2.0 Device information
| Trade name: | AG-607 Blood Glucose Monitoring System |
|---|---|
| AG-607 Multi Blood Glucose Monitoring System | |
| Common name: | Blood Glucose Monitoring System |
| Classification name: | Blood Glucose Monitoring System |
3.0 Classification
| Product code | Classification | Regulation Section | Panel |
|---|---|---|---|
| NBW | II | 21 CFR 862.1345 | Chemistry (75) |
| LFR | II | 21 CFR 862.1345 | Chemistry (75) |
4.0 Predicate device information
| Manufacturer: | Andon Medical Co., Ltd. |
|---|---|
| Device: | AG-608N Single Blood Glucose Monitoring System |
| 510(k) number: | K110017 |
5
5.0 Device description
The AG-607 and AG-607 Multi Glucose Monitoring System (BGMS) consist of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.
They are based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. It uses the same technological characteristics for testing with its predicate device.
6.0 Intended use
The AG-607 blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The AG-607 blood glucose monitoring system is intended to be used by a Single person and should not be shared.
The AG-607 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-607 blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative Site Testing (AST) should be done only during steady-state times (when glucose levels is not changing rapidly).
The EGS-2003 test strips are for use with the AG-607 blood glucose meter to quantitatively measure glucose(sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh.
The AG-607Multi blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The AG-607Multi blood glucose monitoring system is intended for testing outside the body(in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as and aid to monitor the effectiveness of diabetes control program. The system is only used with single-use auto-disabling lancing device.
6
The AG-607Multi blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative Site Testing (AST) should be done only during steady-state times (when glucose levels is not changing rapidly).
The EGS-2003Multi test strips are for use with the AG-607Multi blood glucose meter to quantitatively measure glucose(sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh.
| CHARACTERISTICS | NEW DEVICE:
AG-607 Blood Glucose
Monitoring System | PREDICATE:
AG-608N Single Blood
Glucose Monitoring System
(K110017) |
|--------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Detection Method | Amperometry | Amperometry |
| Enzyme | Glucose dehydrogenase | Glucose Oxidase |
| Type of Meter | Biosensor (Electrode) | Biosensor (Electrode) |
| Sample Source | Capillary whole blood from
AST(Alternative site testing)
and finger | Capillary whole blood from
AST(Alternative site testing)
and finger |
| Sample Application | Blood sample is placed
directly to the test strip after
finger or AST is lanced. | Blood sample is placed
directly to the test strip after
finger or AST is lanced. |
| Hematocrit Range | 20-60% | 20-60% |
| Operating
Temperature Range | $10℃40℃(50°-104°F)$ | $10℃33.3mmol/L) |40℃(50°-104°F)$ |33.3mmol/L) | 20mg/dL-600mg/dL
| Dimensions | 110mm x 52mm x 20.5mm | 87mm×53mm ×9.9mm |
| Display | LCD | LCD |
| Result Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Memory Capabilities | 500 times | 500 times |
| Test Start | Automatic | Automatic |
| Test Time | 5 second | 5 second |
| Power Source | DC3.0V (2×LR03) | DC 3.0V (CR2032) |
| Battery Life | 1000 times | 500 times |
| Measurement Range | 20mg/dL-600mg/dL
(1.1mmol/L
(1.1mmol/L
| Qualified Test Strip | EGS-2003 Test Strip | AGS-1000N Test Strip |
7.0 Summary comparing technological characteristics with predicate device
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| Sample Volume | Minimum 0.7 micro liter | Minimum 0.7 micro liter |
|---|---|---|
| Connect Method | NA | USB |
| Outlook | See Picture 1 | See Picture 2 |
Picture 1: AG-607
Image /page/7/Picture/3 description: The image shows a white Andon blood glucose meter displaying a reading of 94 mg/dL. The time displayed on the meter is 8:01 AM. The meter has a digital display and a simple design with the brand name "andon" printed at the top.
Picture 2 AG-608N
Image /page/7/Picture/5 description: The image shows a white, rectangular device with a screen at the top and two triangular buttons labeled "M" and "S" below the screen. The screen is dark and appears to be off. The device has a simple, minimalist design and is likely an electronic device such as a timer or a remote control.
8.0 Performance summary
The AG-607 and AG-607 Multi Blood Glucose Monitoring System (BGMS) conform to the following standards:
- · ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus .
Non-clinical test and the clinical test are done according to the above standard.
9.0 Comparison to the predict device and the conclusion
The proposed device AG-607 is similar with the predicate device AG-608N, they are both for single patient use, and can test the blood glucose at the alternative site. The hematocrit range, the use function are all the same. The appearance, internal power source and the qualified test strip of the two device is different. Moreover, the new device AG-607 meter does not have the USB function.
However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.