(585 days)
Not Found
No
The description focuses on electrochemical biosensor technology and capillary action for glucose measurement. There is no mention of AI or ML in the intended use, device description, or performance studies. The speaking function is a simple audible output, not indicative of AI/ML.
No
This device is for monitoring glucose levels to aid in diabetes control, not for therapeutic intervention. It is an in vitro diagnostic device.
Yes
Explanation: The device is an "in vitro diagnostic use" device, used to measure glucose in blood samples, which aids in monitoring the effectiveness of diabetes control. While it states it "should not be used for the diagnosis of or screening for diabetes," its function in providing quantitative measurements for monitoring a medical condition classifies it as a diagnostic device.
No
The device description explicitly states it is based on "electrochemical biosensor technology" and "capillary action," and mentions a "meter" and "test strips," indicating the presence of hardware components for blood glucose measurement.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states:
- "The AG-695 Single Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use)..."
- "The AG-695 MULTI Blood Glucose Monitoring System is intended for testing outside the body ( in vitro diagnostic use)..."
- "The AG-696 Single Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use)..."
- "The AG-696 MULTI Blood Glucose Monitoring System is intended for testing outside the body ( in vitro diagnostic use)..."
This clearly indicates that the device is intended for diagnostic testing performed on samples taken from the body, but outside of the body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AG-695 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip. The AG-695 Single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The AG-695 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-695 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.
The AGS-1000 single Blood Glucose Test Strips are for use with the AG-695 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.
The AG-695 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip. The AG-695 MULTI Blood Glucose Monitoring System is intended for testing outside the body ( in vitro diagnostic use) and 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-695 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.
The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-695 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.
The AG-696 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip. The AG-696 Single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The AG-696 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-696 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.
The AGS-1000 single Blood Glucose Test Strips are for use with the AG-696 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.
The AG-696 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip. The AG-696 MULTI Blood Glucose Monitoring System is intended for testing outside the body ( in vitro diagnostic use) and 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-696 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.
The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-696 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.
Product codes
NBW, CGA
Device Description
The four blood Glucose Monitoring system AG-695 Single, AG-695 MULTI, AG-696 Single and AG-696 MILTI are all 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. All of them use the same technological characteristics for testing but the appearance is different from their predicate device. More over, all of the four systems have a voice function.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
AG-695 Single Blood Glucose Monitoring System and AG-696 Single Blood Glucose Monitoring System: a single person with diabetes at home (self testing).
AG-695 MULTI Blood Glucose Monitoring System and AG-696 MULTI Blood Glucose Monitoring System: healthcare professionals for multiple patients in a professional healthcare setting.
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)
AG-695 Single BGMS, AG-695 MULTI BGMS, AG-696 Single BGMS and AG-696 MULTI 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.
- FDA Draft Guidance Document-Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems: October 24, 2006
- Disinfectant CaviWipes with the EPA registration number of 46781-8 has been validated to clean and disinfect the BGMS, and the performance and material will not be effected by the disinfection during the BGMS' lifetime.
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.
0
JUL 1 5 2011
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 Medical Co., Ltd. |
|---|---|
| Address: | No.04-23-3 AIRPORT INDUSTRIAL PARK, TIANJIN |
| Phone number: | · 86-22-8761 2426 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Yi Liu |
| Date of Application: 09/30/2009 |
2.0 Device information
| Trade name: | AG-695 Single Blood Glucose Monitoring System
AG-695 Multi Blood Glucose Monitoring System
AG-696 Single Blood Glucose Monitoring System
AG-696 Multi Blood Glucose Monitoring System |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name: | Blood Glucose Monitoring System |
| Classification name: | Blood Glucose Monitoring System |
3.0 Classification
Production code: NBW- Blood Glucose Monitoring System. Regulation number: 862.1345 Classification: II Panel: Clinical Chemistry
4.0 Predict device information
Manufacturer: Andon Health Co., Ltd. AG-606 Blood Glucose Monitoring System Device: 510(k) number: K073030
5.0 Intended use
5.1 AG-695 Single Blood Glucose Monitoring System
The AG-695 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip.. The AG-695 Single Blood Glucose
1
Monitoring System is intended to be used by a single person and should not be shared.
The AG-695 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-695 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a qlucose test.
The AGS-1000 single Blood Glucose Test Strips are for use with the AG-695 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.
5.2 AG-695 MULTI Blood Glucose Monitoring System
The AG-695 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip.. The AG-695 MULT! Blood Glucose Monitoring System is intended for testing outside the body ( in vitro diagnostic use) and 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-695 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a alucose test.
The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-695 MULT! 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.
5.3 AG-696 Single Blood Glucose Monitoring System
2
The AG-696 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip. The AG-696 Single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The AG-696 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-696 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.
The AGS-1000 single Blood Glucose Test Strips are for use with the AG-696 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.
5.4 AG-696 MULTI Blood Glucose Monitoring System
The AG-696 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip. The AG-696 MULTI Blood Glucose Monitoring System is intended for testing outside the body ( in vitro diagnostic use) and 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-696 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.
The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-696 MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.
3
This system should only be used with single-use, auto-disabling lancing devices.
6.0 Device description
The four blood Glucose Monitoring system AG-695 Single, AG-695 MULTI, AG-696 Single and AG-696 MILTI are all 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. All of them use the same technological characteristics for testing but the appearance is different from their predicate device. More over, all of the four systems have a voice function.
4
7.0 Summary comparing technological characteristics with predicate device
7.1AG-695 Single and AG-695 MULTI Blood Glucose Monitoring System
| Similarities | ||
|---|---|---|
| CHARACTERISTICS | NEW DEVICE: | |
| AG-695 Single and | ||
| AG-695 MULTI Blood | ||
| Glucose Monitoring | ||
| System | PREDICATE: | |
| AG-606 Blood Glucose | ||
| Monitoring System | ||
| (K073030) | ||
| Detection Method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase | Glucose Oxidase |
| Type of Meter | Biosensor (Electrode) | Biosensor (Electrode) |
| Intended Use | To quantitatively measure | |
| glucose in fresh capillary | ||
| whole blood. | To quantitatively measure | |
| glucose in fresh capillary | ||
| whole blood. | ||
| Sample Source | Capillary whole blood | Capillary whole blood |
| Sample Application | Blood sample is placed | |
| directly to the test strip after | ||
| finger is lanced. | Blood sample is placed | |
| directly to the test strip after | ||
| finger is lanced. | ||
| Hematocrit Range | 30-55% | 30-55% |
| Operating Temperature | ||
| Range | 10℃~40℃(50°-104°F) | 10℃~40℃(50°-104°F) |
| Dimensions | 52mmx 92mmx 21mm | 82mmx 59mmx 20mm |
| Display | LCD | LCD |
| Result Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Memory Capabilities | 350 times with time and date | |
| displaying | 350 times with time and date | |
| displaying | ||
| Test Start | Automatic | Automatic |
| Test Time | 5 second | 5 second |
| Power Source | DC 3V (2 AAA) | DC 3V (2 AAA) |
| Battery Life | Approx. 1000 normal tests | Approx. 1000 normal tests |
| Measurement Range | 20mg/dL-600mg/dL | |
| (1.1mmol/L~33.3mmol/L) | 20mg/dL-600mg/dL | |
| (1.1mmol/L~33.3mmol/L) | ||
| Qualified Test Strip | AGS-1000 Single Test Strip | |
| for AG-695 Single BGMS | ||
| AGS-1000 MULTI Test strip | ||
| for AG-695 MULTI BGMS | AGS-600 Test Strip | |
| Sample Volume | Minimum 0.7 microliter | Minimum 1 microliter |
| Other function | Voice function | N/A |
5
7.2 AG-696 Single and MULTI Blood Glucose Monitoring System
| CHARACTERISTICS | NEW DEVICE:
AG-696 Single and
AG-696 MULTI Blood
Glucose Monitoring
System | PREDICATE:
AG-606 Blood Glucose
Monitoring System
(K073030) |
|-----------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Detection Method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase | Glucose Oxidase |
| Type of Meter | Biosensor (Electrode) | Biosensor (Electrode) |
| Intended Use | To quantitatively measure
glucose in fresh capillary
whole blood. | To quantitatively measure
glucose in fresh capillary
whole blood. |
| Sample Source | Capillary whole blood | Capillary whole blood |
| Sample Application | Blood sample is placed
directly to the test strip after
finger is lanced. | Blood sample is placed
directly to the test strip after
finger is lanced. |
| Hematocrit Range | 30-55% | 30-55% |
| Operating Temperature Range | 10℃40℃(50°-104°F) | 10℃33.3mmol/L) |40℃(50°-104°F) |33.3mmol/L) | 20mg/dL-600mg/dL
| Dimensions | 90mmx 59mmx 22mm | 82mmx 59mmx 20mm |
| Display | LCD | LCD |
| Result Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Memory Capabilities | 500 times with time and date
displaying | 350 times with time and date
displaying |
| Test Start | Automatic | Automatic |
| Test Time | 5 second | 5 second |
| Power Source | DC3V (2XAAA batteries) | DC 3V (2 AAA) |
| Battery Life | Approx. 1000 normal tests | Approx. 1000 normal tests |
| Measurement Range | 20mg/dL-600mg/dL
(1.1mmol/L
(1.1mmol/L
| Qualified Test Strip | AGS-1000 Single Test Strip for
AG-696 Single BGMS
AGS-1000 MULTI Test strip
for AG-696 MULTI BGMS | AGS-600 Test Strip |
| Sample Volume | Minimum 0.7 micro liter | Minimum 1 microliter |
| Other function | voice function | N/A |
6
8.0 Performance summary
AG-695 Single BGMS, AG-695 MULTI BGMS, AG-696 Single BGMS and AG-696 MULTI 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.
- · FDA Draft Guidance Document-Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems: October 24, 2006
- · Disinfectant CaviWipes with the EPA registration number of 46781-8 has been validated to clean and disinfect the BGMS, and the performance and material will not be effected by the disinfection during the BGMS' lifetime.
9.0 Comparison to the predict device and the conclusion
The four blood glucose monitor AG-695 Single AG-695 MULTI, AG-696 Single and AG-696 MULTI are very similar with the predicate device AG-606, their appearance is different from AG-606, they use the different test strips, they also has a new voice function. And the intended use of AG-695 MULTI and AG-696 MULTI are also different from their predicate device.
However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Andon Medical Co., Ltd. c/o Yi Liu No. 04-23-3 Airport Industrial Park Tianjin, China 300381
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Jul 1 5 2011
Re: K093755
AG-695 Single Blood Glucose Monitoring System Trade name: AG-695 Multi Blood Glucose Monitoring System AG-696 Single Blood Glucose Monitoring System AG-696 Multi Blood Glucose Monitoring System
Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: July 13, 2011 Received: July 13, 2011
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.
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).
8
Page 2
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Signature
Courtney C. 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
9
AG-695 Blood Glucose Monitoring System FDA 510(k) Files
Indication for Use
510(k) Number (if known): K093755 Device Name: AG-695 Single Blood Glucose Monitoring System Indication for Use:
The AG-695 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip.. The AG-695 Single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The AG-695 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-695 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.
The AGS-1000 single Blood Glucose Test Strips are for use with the AG-695 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.
| Prescription Use
✓ | And/Or | Over the Counter Use
✓ |
|-----------------------------|--------|-----------------------------|
| (21 CFR Part 801 Subpart D) | | (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)
. �
િન્દ
Page 1 of _
Ruth Chuber
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(K) 长 o 8 37 5 5
10
AG-695 MULTI Blood Glucose Monitoring System FDA 510(k) Files
Indication for Use
510(k) Number (if known): K093755
Device Name: AG-695 MULTI Blood Glucose Monitoring System Indication for Use:
The AG-695 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip.. The AG-695 MULTI Blood Glucose Monitoring System is intended for testing outside the body ( in vitro diagnostic use) and 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-695 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.
The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-695 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.
Over the Counter Use Prescription Use And/Or (21 CFR Part 801 Subpart C) (21 CFR Part 801 Subpart D) (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)
(ONVD)
Ruth Chuse
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093758
11
AG-696 single Blood Glucose Monitoring System FDA 510(k) Files
Indication for Use
K093755 510(k) Number (if known): Device Name: AG-696 Single Blood Glucose Monitoring System Indication for Use:
The AG-696 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of qlucose (sugar) in fresh capillary whole blood sample from the fingertip. The AG-696 Single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The AG-696 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-696 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.
The AGS-1000 single Blood Glucose Test Strips are for use with the AG-696 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.
| Prescription Use ✓ | And/Or | Over the Counter Use ✓ |
|---|---|---|
| (21 CFR Part 801 Subpart D) | (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)
Ruth Chester
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093755
Page 3 of 4
12
AG-696 MULTI Blood Glucose Monitoring System FDA 510(k) Files
Indication for Use
510(k) Number (if known): K093755
Device Name: AG-696 MULTI Blood Glucose Monitoring System Indication for Use:
The AG-696 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip. The AG-696 MULTI Blood Glucose Monitoring System is intended for testing outside the body ( in vitro diagnostic use) and 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-696 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.
The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-696 MULT! 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 J And/Or . Over the Counter Use J (21 CFR Part 801 Subpart D) (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)
Qute Chula
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 093755
Page 4 of 4