(113 days)
Not Found
No
The document describes a standard electrochemical blood glucose monitoring system and a mobile app for data management. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is an in vitro diagnostic device used for monitoring blood glucose levels, not for therapeutic intervention.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "iHealth BG5 and BG5L wireless Smart Gluco-Monitoring System should not be used for the diagnosis of or screening for diabetes."
No
The device description explicitly states that the system consists of a blood glucose meter, test strips, lancets, lancing device, and control solutions, in addition to the software application. This indicates the presence of significant hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use section explicitly states:
- "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"
This statement clearly indicates that the device is intended for diagnostic testing performed outside of the body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
iHealth BG5 and BG5L wireless Smart Gluco-Monitoring System is intended to be used for:
quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh
. single person measurement only and should not be shared
. 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
iHealth BG5 and BG5L wireless Smart Gluco-Monitoring System should not be used for the diagnosis of or screening for diabetes, or for neonatal use.
Alternative Site Testing (AST) should be done only during steady state times when glucose levels are not changing rapidly.
The AGS1000I test strips are intended for use with the iHealth BG5 and BG5L meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG5 and BG5L meter.
The iHealth control solutions are intended for use with the iHealth BG5/BG5L Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
The iHealth Gluco-Smart App is an iOS app for iPhone, iTouch, and iPad and is used for data extraction and analysis in iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, JQP, JJX
Device Description
iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System consist of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.
The new device iHealth BG5 and BG5L Wireless Smart Glucose meters 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.
The new device iHealth BG5 and BG5L meters can display the test results itself, it can also transmit the test results to the an iPhone, iPod touch or iPad through blue tooth.
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 or thigh
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Self-testing by people with diabetes at home.
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 following standards:
- ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
- IEC 61010-1 : 2001, Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General requirements
- EN 61326-1:2006Electrical equipment for measurement, control and laboratory use - EMC requirements part 1: General requirements
- EN 61326-2-6 Electrical equipment for measurement, control and laboratory use - EMC requirements Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
- IEC 61010-2-101 : 2002,Particular requirements for in vitro diagnostic (IVD) medical equipment
- CLSI EP6-A:2003,Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
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
123935
510(k) Summary
APR 1 2 2013
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
ﺮ
| Name: | Andon Medical Co., Ltd. |
|---|---|
| Address: | No.26 Hang Yu Road, Tianjin Airport Economic Area, Tianjin, |
| P.R. China | |
| Phone number: | 86-22-8761 2426 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Yi Liu |
| Date of Application: | 12/14/2012 |
2.0 Device information
| Trade name: | iHealth BG5 Wireless Smart Gluco-Monitoring System |
|---|---|
| iHealth BG5L Wireless Smart Gluco-Monitoring System | |
| Common name: | Blood Glucose Monitoring System |
| Classification name: | Blood Glucose Monitoring System |
3.0 Classification
| Product Code | Classification | Regulation
Section | Panel |
|------------------------------------------------------------------------------|----------------|-----------------------|-----------------------|
| NBW- Blood Glucose Monitoring
System. | Class II | 862.1345 | Clinical
Chemistry |
| CGA- test, blood glucose, over the
counter | Class II | 862.1345 | Clinical
Chemistry |
| JQP- calculator/data processing
module, for clinical use. | Class I | 862.2100 | Clinical
Chemistry |
| JJX-
single
(specified)
analyte
controls (assayed and unassayed) | Class I | 862.1660 | Clinical
Chemistry |
5- I
1
| 1 | Manufacturer: | Andon Medical Co., Ltd. |
|---|---|---|
| Device: | iHealth BG3 Smart Gluco-monitoring System | |
| 510(k) number: | K120813 | |
| 2 | Manufacturer: | Andon Medical Co., Ltd. |
| Device: | AG-608N Blood Glucose monitoring System | |
| 510(k) number: | K110017 |
4.0 Predicate device information
5.0 Device description
iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System consist of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.
The new device iHealth BG5 and BG5L Wireless Smart Glucose meters 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.
The new device iHealth BG5 and BG5L meters can display the test results itself, it can also transmit the test results to the an iPhone, iPod touch or iPad through blue tooth.
6.0 Intended use
iHealth BG5 and BG5L wireless Smart Gluco-Monitoring System is intended to be used for:
quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh
- . single person measurement only and should not be shared
. 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
iHealth BG5 and BG5L wireless Smart Gluco-Monitoring System should
2
not be used for the diagnosis of or screening for diabetes, or for neonatal use.
Alternative Site Testing (AST) should be done only during steady state times when glucose levels are not changing rapidly.
The AGS1000I test strips are intended for use with the iHealth BG5 and BG5L meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG5 and BG5L meter.
The iHealth control solutions are intended for use with the iHealth BG5/BG5L Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
The iHealth Gluco-Smart App is an iOS app for iPhone, iTouch, and iPad and is used for data extraction and analysis in iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System.
| NEW DEVICE: | PREDICATE: | |
|---|---|---|
| CHARACTERISTICS | iHealth BG5 and BG5L | |
| wireless Smart | ||
| Gluco-Monitoring System | iHealth BG3 Smart | |
| Gluco-Monitoring | ||
| System(K120813) | ||
| Detection Method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase | 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℃~35℃(50°-95°F) | 10℃~35℃(50°-95°F) |
| Dimensions | 9mm × 34.5mm ×19mm | 102mm×58mm ×22mm |
| Display | LED display, | |
| Display on iPhone, iPod | Connect to iPone or iPod | |
| touch to display |
7.0 Summary comparing technological characteristics with predicate device
5- 3
3
| | touch or iPad connected
through Bluetooth | measurement results |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Result Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Memory Capabilities | 500 times with time and date
displaying | 10000 times with time and
date displaying |
| Test Start | Automatic | Automatic |
| Test Time | 5 second | 5 second |
| Power Source | DC 3.7V d.c.
li-ion 250mAh | DC 3.3V
(Powered by iOS device
connected to the meter) |
| Battery Life | N/A | N/A |
| Measurement Range | 20mg/dL-600mg/dL
(1.1mmol/L33.3mmol/L) | 20mg/dL-600mg/dL33.3mmol/L) |
(1.1mmol/L
| Qualified Test Strip | AGS-1000I Test Strip | AGS-1000I Test Strip |
| Sample Volume | Minimum 0.7 micro liter | Minimum 0.7 micro liter |
| Other function | Transmit measure data to
iPhone or iPod through blue
tooth.
iHealth BG5L use Bluetooth
4.0 wireles radio technology;
and
iHealth BG5 use Bluetooth
3.0 wireles radio technology | N/A |
| Control solution | iHealth Control solution
(Level I / II / III )
The control solution is
exactly the same as
AG-608N control solution,
only the name is different | AG-608N control solution
(cleared in K110017) |
8.0 Performance summary
.
・
.
.
iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System conforms to the following standards:
- · ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
- IEC 61010-1 : 2001, Safety requirements for electrical equipment for
4
measurement, control, and laboratory use Part 1: General requirements
- · EN 61326-1:2006Electrical equipment for measurement, control and laboratory use - EMC requirements part 1: General requirements
- · EN 61326-2-6 Electrical equipment for measurement, control and laboratory use - EMC requirements Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
- · IEC 61010-2-101 : 2002,Particular requirements for in vitro diagnostic (IVD) medical equipment
- · CLSI EP6-A:2003,Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
Non-clinical test and the clinical test are done according to the above standard.
9.0 Comparison to the predict device and the conclusion
iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System is similar with the predicate device iHealth BG3 Smart Glucose Monitoring System, they are all for single people use, they use the same test strip, and can test the blood glucose at the alternative site. The hematocrit range, the altitude and the use function are all the same. The appearance of the new devices is different, and iHealth BG5 and BG5L meter obtain LED display on the devices, and can complete the measurement function themselves. Moreover, the new device BG5 and BG5L can connect to an iPone, iPod touch or iPad to display measurement results through Bluetooth.
However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and is evenly spaced around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 12, 2013
Andon Medical Co., Ltd. C/O Yi Liu NO. 26 HANGYU ROAD TIANJIN AIRPORT ECONOMIC AREA TIANJIN, CHINA 300381
Re: K123935
Trade/Device Name: iHealth BG5 Wireless Smart Gluco-Monitoring System iHealth BG5L Wireless Smart Gluco-Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JQP, JJX Dated: March 08, 2013 Received: March 12, 2013
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 Part 801); 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
Page 2— Yi Liu
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
Indication for Use
510(k) Number (if known): K123935
Device Name: iHealth BG5 Wireless Smart Gluco-Monitoring System
Indications For Use:
iHealth BG5 wireless Smart Gluco-Monitoring System is intended to be used for:
- quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh
- single person measurement only and should not be shared .
- 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
iHealth BG5 wireless Smart Gluco-Monitoring System should not be used for the diagnosis of or screening for diabetes, or for neonatal use.
Alternative Site Testing (AST) should be done only during steady state times when glucose levels are not changing rapidly.
The AGS10001 test strips are intended for use with the iHealth BG5 meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG5 meter.
The iHealth control solutions are intended for use with the iHealth BG5 Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
The iHealth Gluco-Smart App is an iOS app for iPhone, iTouch, and iPad and is used for data extraction and analysis in iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over-The-Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)
Yunq W. Mahan -S
Division Sign-Off Office of In Vitro Devices and Radiologic Health
K123935 510(k) =
Page 1 of 2
8
Indication for Use
510(k) Number (if known): K123935
Device Name: iHealth BG5L Wireless Smart Gluco-Monitoring System
Indications For Use:
iHealth BG5L wireless Smart Gluco-Monitoring System is intended to be used for:
quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh
- single person measurement only and should not be shared .
- 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
iHealth BG5L wireless Smart Gluco-Monitoring System should not be used for the diagnosis of or screening for diabetes, or for neonatal use.
Alternative Site Testing (AST) should be done only during steady state times when glucose levels are not changing rapidly.
The AGS1000I test strips are intended for use with the iHealth BG5 meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG5L meter.
The iHealth control solutions are intended for use with the iHealth BG5L Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
The iHealth Gluco-Smart App is an iOS app for iPhone, iTouch, and iPad and is used for data extraction and analysis in iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System.
And/Or Prescription Use Over-The-Counter Use J イ (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 Devices and Radiologic Health (OIR)
Yung Wilehan -S
Division Sign-Off Office of In Vitro Devices and Radiologic Health
510(k)_k123935