(456 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 only additional feature mentioned is a voice function for visually impaired users, which is not AI/ML.
No.
Explanation: This device is for measuring blood glucose levels to monitor the effectiveness of diabetes control, not for providing therapy or treatment. It is an in vitro diagnostic device used for measurement and monitoring, not for direct therapeutic intervention.
Yes
Explanation: The device is intended for "in vitro diagnostic use" to measure glucose, which falls under the definition of a diagnostic device. While it specifies "should not be used for the diagnosis of or screening for diabetes," its purpose is to provide quantitative measurements that aid in monitoring diabetes control, a crucial aspect of managing a health condition.
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).
The intended use statements for all the described systems (AG-6081 Single, AG-6951 Single, AG-6081 MULTI, and AG-6951 MULTI) explicitly state that they are intended for "in vitro diagnostic use".
Furthermore, the description of the device and its components (blood glucose meter, test strips, control solutions) and how they are used to measure glucose in blood samples outside the body aligns with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AG-6081 Single 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 and thigh. The AG-6081 Single Blood Glucose Monitoring System is to be used by a single person and should not be shared.
The AG-6081 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-6081 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The AGS-1100 Single Blood Glucose Test Strips are for use with the AG-6081 Single Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.
The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6081 Single meters and AGS-1100 Single test strips.
The AG-6081 MULTI 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 and thigh. The AG-6081 MULTI 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 an aid to monitor the effectiveness of a diabetes control program.
The AG-6081 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly).
The AGS-1100 MULTI Blood Glucose Test Strips are for use with the AG-6081 MULTI Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.
The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6081 MULTI meters and AGS-1100 MULTI test strips.
The AG-6951 Single 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 and thigh. The AG-6951 Single Blood Glucose Monitoring System is to be used by a single person and should not be shared.
The AG-6951 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-6951 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady – state times (when glucose is not changing rapidly).
The AGS-1100 Single Blood Glucose Test Strips are for use with the AG-6951 Single Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.
The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6951 Single meters and AGS-1100 Single test strips.
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 AG-6951 MULTI 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 and thigh. The AG-6951 MULTI 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 an aid to monitor the effectiveness of a diabetes control program.
The AG-6951 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly).
The AGS-1100 MULTI Blood Glucose Test Strips are for use with the AG-6951 MULTI Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.
The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6951 MULTI meters and AGS-1100 MULTI test strips.
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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, JJX
Device Description
AG-6081 and AG-6951 Single Blood Glucose Monitoring System (BGMS) consist of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.
While AG-6081 and AG-6951 MULTI Blood Glucose Monitoring System (BGMS) consist of blood glucose meter, MULT! use test strips, Auto-disabling Lancing device and the control solutions.
The four blood Glucose Monitoring system AG-6081 Single, AG-6951 Single, AG-6081 MULTI and AG-6951 MULTI 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 with their predicate device. Only the appearance is different from their predicate device, and the new devices can test the blood glucose at the alternative site: the palm, the forearm, the upper arm, the calf and the thigh.
More over, AG-6951 Single and AG-6951 MULTI Blood Glucose Monitoring Systems have a voice function, which is also different from their predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip, palm, forearm, upper arm, calf, thigh
Indicated Patient Age Range
Not Found
Intended User / Care Setting
AG-6081 Single Blood Glucose Monitoring System and AG-6951 Single Blood Glucose Monitoring System are intended for self testing by people with diabetes at home.
AG-6081 MULTI Blood Glucose Monitoring System and AG-6951 MULTI Blood Glucose Monitoring System are intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program.
The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus.
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-6081 Single BGMS, AG-6081 MULTI BGMS, AG-6951 Single BGMS and AG-6951 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
- CLSI/NCCLS Guideline, EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline-Second edition
The test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.
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
Additional information for K101307 柯 顿(天 津) 电 子 医 疗 器 械 有 限 公 司 Andon Medical Co., Ltd. 地址:天津市,天津空港经济开发区,航宇路26号 AUG - 9 2011 Add: No.26 HangYu Road, Tianjin Airport Economic Area, Tianjin, P.R. China 邮编(P.C.) 300381
传真(Fax): 86-22-6052 6162 电话(Tel): 86-22-87612426 E-mail : andonmedical@yahoo.com.cn
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: | 5/9/2010 |
2.0 Device name
AG-6081 Single Blood Glucose Monitoring System AG-6951 Single Blood Glucose Monitoring System AG-6081 MULTI Blood Glucose Monitoring System AG-6951 MULTI 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. Device: AG-606 Blood Glucose Monitoring System 510(k) number: K073030
5.0 Intended use
5.1 AG-6081 Single and AG-6951 Single BGMS
The AG-6081 Single Blood Glucose Monitoring System is intended to be used
1
for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The AG-6081 Single Blood Glucose Monitoring System is to be used by a single person and should not be shared.
The AG-6081 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-6081 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The AGS-1100 Single Blood Glucose Test Strips are for use with the AG-6081 Single Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.
The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6081 Single meters and AGS-1100 Single test strips.
The AG-6951 Single 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 and thigh. The AG-6951 Single Blood Glucose Monitoring System is to be used by a single person and should not be shared.
The AG-6951 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-6951 Single Blood Glucose Monitoring System should not be used for the diagnosis
2
Additional information for K101307 柯 顿 (天 津) 电 子 医 疗 器 械 有 限 公 司 Andon Medical Co., Ltd. 地址:天津市,天津空港经济开发区,航宇路26号 Add: No.26 HangYu Road, Tianjin Airport Economic Area, Tianjin, P.R. China 邮编(P.C.): 300381 电话(Tel): 86-22-87612426 传真(Fax): 86-22-6052 6162 E-mail: andonmedical@yahoo.com.cn
of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The AGS-1100 Single Blood Glucose Test Strips are for use with the AG-6951 Single Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.
The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6951 Single meters and AGS-1100 Single test strips.
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.
5.2 AG-6081 MULTI and AG-6951 MULTI BGMS
The AG-6081 MULTI 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 and thigh. The AG-6081 MULTI 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 an aid to monitor the effectiveness of a diabetes control program.
The AG-6081 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly).
The AGS-1100 MULTI Blood Glucose Test Strips are for use with the AG-6081 MULTI Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper
3
Additional information for K101307 柯 顿(天 津)电子 医疗 器 械 有 限 公 司 Andon Medical Co., Ltd. 地址:天津市,天津空港经济开发区,航宇路26号 Add: No.26 HangYu Road, Tianjin Airport Economic Area, Tianjin, P.R. China 邮编(P.C.): 300381 电话(Tel): 86-22-87612426 传真(Fax): 86-22-6052 6162 E-mail: andonmedical@yahoo.com.cn
arm, calf and thigh.
The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6081 MULTI meters and AGS-1100 MULTI test strips.
The AG-6951 MULTI 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 and thigh. The AG-6951 MULTI 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 an aid to monitor the effectiveness of a diabetes control program.
The AG-6951 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly).
The AGS-1100 MULTI Blood Glucose Test Strips are for use with the AG-6951 MULTI Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.
The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6951 MULTI meters and AGS-1100 MULTI test strips.
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.
4
Additional information for K101307 柯顿(天津)电子医疗器械有限公司 Andon Medical Co., Ltd. 地址:天津市,天津空港经济开发区,航宇路26号 Add: No.26 HangYu Road, Tianjin Airport Economic Area, Tianjin, P.R. China 邮编(P.C.): 300381 传真(Fax): 86-22-6052 6162 电话(Tel): 86-22-87612426 E-mail: andonmedical@yahoo.com.cn
6.0 Device description
AG-6081 and AG-6951 Single Blood Glucose Monitoring System (BGMS) consist of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.
While AG-6081 and AG-6951 MULTI Blood Glucose Monitoring System (BGMS) consist of blood glucose meter, MULT! use test strips, Auto-disabling Lancing device and the control solutions.
The four blood Glucose Monitoring system AG-6081 Single, AG-6951 Single, AG-6081 MULTI and AG-6951 MULTI 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 with their predicate device. Only the appearance is different from their predicate device, and the new devices can test the blood glucose at the alternative site: the palm, the forearm, the upper arm, the calf and the thigh.
More over, AG-6951 Single and AG-6951 MULTI Blood Glucose Monitoring Systems have a voice function, which is also different from their predicate device.
5
柯 顿 (天 津) 电 子 医 疗 器 械 有 限 公 司
Andon Medical Co., Ltd. 地址:天津市,天津空港经济开发区,航宇路 26号 Add: No.26 HangYu Road, Tianjin Airport Economic Area, Tianjin, P.R. China 邮编(P.C.): 300381 传真(Fax): 86-22-6052 6162 电话(Tel): 86-22-87612426 E-mail: andonmedical@yahoo.com.cn
7.0 Summary_comparing technological characteristics with predicate device
7.1 AG-6081 Single and AG-6081 MULTI BGMS
| Similarities | ||
|---|---|---|
| NEW DEVICE: | PREDICATE: | |
| CHARACTERISTICS | AG-6081 Single and | AG-606 Blood Glucose |
| AG-6081 MULTI Blood | Monitoring System | |
| Glucose Monitoring System | (K073030) | |
| Detection Method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase | Glucose Oxidase |
| Type of Meter | Biosensor (Electrode) | Biosensor (Electrode) |
| Operating | ||
| Temperature | 10°C~40°C(50°-104°F) | 10°C ~40°C(50°-104°F) |
| Range | LCD | LCD |
| Result Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Test Start | Automatic | Automatic |
| Test Time | 5 seconds | 5 seconds |
| Battery Life | Approx. 500 normal tests | Approx. 1000 normal tests |
| Measurement Range | 20mg/dL-600mg/dL | 20mg/dL-600mg/dL |
| (1.1mmol/L~33.3mmol/L) | (1.1mmol/L~33.3mmol/L) | |
| Differences | ||
| AG-6081 Single and | AG-606 Blood Glucose | |
| CHARACTERISTICS | AG-6081 MU MULTI Blood | Monitoring System |
| Glucose Monitoring System | (K073030) | |
| Sample Source | AST(Alternative site testing) | Capillary whole blood |
| Hematocrit Range | 20-60% | 30-55% |
| Dimensions | 87mmx 53mmx 9.9mm | 82mmx 59mmx 20mm |
| Memory Capabilities | 500 times with time and date | 350 times with time and date |
| displaying | displaying | |
| Power Source | DC 3V (CR2032) | DC 3V (2 AAA) |
| Qualified Test Strip | AGS-1100 Single Test strip for | AGS-600 Test Strip |
| AG-6081 Single BGMS | ||
| and AGS-1100 MULTI Test | ||
| Strip for AG-6081 | ||
| MULTI | ||
| BGMS | ||
| Sample Volume | Minimum 0.7 micro liter | Minimum 1 micro liter |
| Other function | USB function | N/A |
| Intended Use | To quantitatively measure glucose. | To quantitatively measure glucose in fresh capillary whole blood. |
| Sample Application | Blood sample is placed directly to the test strip after finger or other part of the body is lanced. | Blood sample is placed directly to the test strip after finger is lanced. |
| Similarities | ||
| CHARACTERISTICS | NEW DEVICE: | |
| AG-6951 Single and | ||
| AG-6951 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) |
| Operating Temperature | 10℃~40℃(50°-104°F) | 10℃~40℃(50°-104°F) |
| Display | LCD | LCD |
| Result Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Test Start | Automatic | Automatic |
| Test Time | 5 second | 5 second |
| Power Source | DC 3V (2 AAA) | DC 3V (2 AAA) |
| Measurement Range | 20mg/dL-600mg/dL | |
| (1.1mmol/L~33.3mmol/L) | 20mg/dL-600mg/dL | |
| (1.1mmol/L~33.3mmol/L) | ||
| Differences | ||
| CHARACTERISTICS | NEW DEVICE: | |
| AG-6951 Blood Glucose | ||
| Monitoring System | PREDICATE: | |
| AG-606 Blood Glucose | ||
| Monitoring System | ||
| (K073030) | ||
| Intended Use | To quantitatively measure | |
| glucose. | To quantitatively measure | |
| glucose in fresh capillary | ||
| whole blood. | ||
| Sample Source | AST(Alternative site testing) | Capillary whole blood |
| Sample Application | Blood sample is placed | |
| directly to the test strip after | ||
| finger or other part of the body | ||
| is lanced. | Blood sample is placed | |
| directly to the test strip after | ||
| finger is lanced. | ||
| Hematocrit Range | 20-60% | 30-55% |
| Dimensions | 52mmx 92mmx 21mm | 82mmx 59mmx 20mm |
| Memory Capabilities | 500 times with time and date | |
| displaying | 350 times with time and date | |
| displaying | ||
| Battery Life | Approx. 500 normal tests | Approx. 1000 normal tests |
| Qualified Test Strip | AGS-1100 Single Test strip for | |
| AG-6951 Single BGMS | AGS-600 Test Strip | |
| and AGS-1100 MULTI Test | ||
| Strip for AG-6951 MULTI | ||
| BGMS | ||
| Sample Volume | Minimum 0.7 microliter | Minimum 1 microliter |
| Other function | Voice function | N/A |
6
柯 顿(天 津)电 子 医 疗 器 械 有 限 公 司
Andon Medical Co., Ltd.
地址:天津市,天津空港经济开发区,航宇路 26 号 Add: No.26 HangYu Road, Tianjin Airport Economic Area, Tianjin, P.R. China 邮编(P.C.): 300381
传真(Fax): 86-22-6052 6162 电话(Tel): 86-22-87612426 E-mail: andonmedical@yahoo.com.cn
7
柯 顿 (天 津) 电 子 医 疗 器 械 有 限 公 司
Andon Medical Co., Ltd. 地址:天津市,天津空港经济开发区,航宇路 26 号
Add: No.26 HangYu Road, Tianjin Airport Economic Area, Tianjin, P.R. China 邮编(P.C.): 300381 电话(Tel): 86-22-87612426 E-mail: andonmedical@yahoo.com.cn
7.2 AG-6951 Single and AG-6951 MULTI BGMS
8
柯 顿 (天 津) 电 子 医 疗 器 械 有 限 公 司
Andon Medical Co., Ltd.
地址:天津市,天津空港经济开发区,航宇路 26 号 Add: No.26 HangYu Road, Tianjin Airport Economic Area, Tianjin, P.R. China 邮编(P.C.): 300381
电话(Tel): 86-22-87612426 传真 (Fax): 86-22-6052 6162 E-mail: andonmedical@yahoo.com.cn
9
Additional information for K101307 柯 顿 (天 津) 电 子 医 疗 器 械 有 限 公 司 Andon Medical Co., Ltd. 地址:天津市,天津空港经济开发区,航宇路26号 Add: No.26 HangYu Road, Tianjin Airport Economic Area, Tianjin, P.R. China 邮编(P.C.): 300381 传真(Fax): 86-22-6052 6162 电话(Tel): 86-22-87612426 E-mail: andonmedical@yahoo.com.cn
8.0 Performance summary
AG-6081 Single BGMS, AG-6081 MULTI BGMS, AG-6951 Single BGMS and AG-6951 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
- · CLSI/NCCLS Guideline, EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline-Second edition
9.0 Comparison to the predict device and the conclusion
The four blood glucose monitor AG-6081 Single, AG-6081 MULTI, AG-6951 Single and AG-6951 MULTI are very similar with the predicate device AG-606. Their appearance is different from AG-606, they use the different test strips, and the intended use of AG-6081 MULTI and AG-6951 MULTI Blood Glucose Monitoring Systems are also different from their predicate device AG-606. Besides, the four new devices can test the blood glucose at the alternative site other than the finger, and they have the USB function as well. More over, AG-6951 Single and AG-6951 MULTI BGMS have a new voice function.
However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.
10
Image /page/10/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
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
AUG 0 9 2011
Re: K101307
Trade name: AG-6081 Single Blood Glucose Monitoring System AG-6081 Multi Blood Glucose Monitoring System AG-6951 Single Blood Glucose Monitoring System AG-6951 Multi Blood Glucose Monitoring System AGS-1100 Control Solution Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System
Regulatory Class: Class II
Product Code: NBW. CGA. JJX Dated: July 25, 2011
Received: July 28, 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).
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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 paremarket 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/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 tolli-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
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510(k) Number (if known): K 101307
Device Name: AG-6081 Single Blood Glucose Monitoring System
Indication for Use:
The AG-6081 Sinale 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 and thigh. The AG-6081 Single Blood Glucose Monitoring System is to be used by a single person and should not be shared.
The AG-6081 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-6081 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The AGS-1100 Single Blood Glucose Test Strips are for use with the AG-6081 Single Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.
The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6081 Single meters and AGS-1100 Single test strips.
Prescription Use J J (Part 21 CFR 801 Subpart D) And/Or
Over the Counter Use (21 CFR 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 (OIVD)
Rita charles
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k 101307
t Page 1 of
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510(k) Number (if known): K /0 / 30'7
Device Name: AG-6081 MULTI Blood Glucose Monitoring System
Indication For Use:
The AG-6081 MULTI 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 and thigh. The AG-6081 MULTI 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 an aid to monitor the effectiveness of a diabetes control program.
The AG-6081 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly).
The AGS-1100 MULTI Blood Glucose Test Strips are for use with the AG-6081 MULTI Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.
The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6081 MULTI meters and AGS-1100 MULTI test strips.
Prescription Use And/Or (Part 21 CFR 801 Subpart D)
Over the Counter Use √ (21 CFR 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 (OIVD)
Ruth Chesler
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety k 10 1307 510(k)
Page: 1 of
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K101307 510(k) Number (if known):
Device Name: AG-6951 Single Blood Glucose Monitoring System
Indication For Use:
The AG-6951 Single 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 and thigh. The AG-6951 Single Blood Glucose Monitoring System is to be used by a single person and should not be shared.
The AG-6951 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-6951 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady – state times (when glucose is not changing rapidly).
The AGS-1100 Single Blood Glucose Test Strips are for use with the AG-6951 Single Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.
The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6951 Single meters and AGS-1100 Single test strips.
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.
Over the Counter Use √ Prescription Use And/Or (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD) Suite Chiller
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
101307 510(k)
Page 3 of 4
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510(k) Number (if known):
Device Name: AG-6951 MULTI Blood Glucose Monitoring System
Indication For Use:
The AG-6951 MULTI 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 and thigh. The AG-6951 MULTI 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 an aid to monitor the effectiveness of a diabetes control program.
The AG-6951 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly).
The AGS-1100 MULTI Blood Glucose Test Strips are for use with the AG-6951 MULTI Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.
The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6951 MULTI meters and AGS-1100 MULTI test strips.
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.
Prescription Use Over the Counter Use And/Or (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)
Ruta Club
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101307
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