(164 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 device description, intended use, or performance studies.
No
The device is intended for monitoring blood glucose levels in people with diabetes, not for treating or preventing the disease.
No.
The document explicitly states: "The iHealth 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, which are all hardware components. While it connects to an iOS device for displaying results, the core measurement is performed by the hardware meter and test strips.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for 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".
- Definition of IVD: An IVD is a medical device used to examine specimens taken from the body, such as blood, to provide information for diagnosis, monitoring, or screening. This device analyzes blood samples to measure glucose levels, which fits this definition.
- Measurement of Analytes: The device measures glucose, which is an analyte in a biological sample.
- Use Outside the Body: The intended use clearly states "Self-testing outside the body".
Therefore, based on the provided text, the iHealth Align Mini Gluco-Monitoring system (BG1) is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The iHealth Align Mini Gluco-Monitoring system(BG1) 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
The iHealth 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.
iHealth Blood Glucose Test Strips(AGS-1000I) are intended for use with the iHealth Align Mini Glucose meter (BG1) to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG1 meter.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, JQP
Device Description
The iHealth BG1 Align Mini Gluco-Monitoring System (BGMS) consists of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.
The new device iHealth BG1 is 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 appearance of iHealth BG1 is different from the predicate device. Both the iHealth BG1 and the predicate device BG3 need to connect to iOS device to display the rest results, however, iHealth BG1 connect to iOS device through the earphone kack, while BG3 connect to iOS device through the 30-pin dock interface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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
people with diabetes at home
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The iHealth BG1 Align Mini 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.
Non-clinical test and the clinical test are done according to the above standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.
1.0 submitter's information_
| Name: | Andon Health Co., Ltd. |
|---|---|
| Address: | No.3 Jinping Street, Ya'an Road, Nankai District, Tianjin, |
| P.R. China | |
| Phone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Yi Liu |
| Date of Application: | 12/03/2013 |
2.0 Device information
| Trade name: | iHealth BG1 Align Mini Gluco-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
Production code: CGA- test, blood glucose, over the counter Regulation number: 862.1345 Classification: II Panel: Clinical Chemistry
Production code: JQP- calculator/data processing module, for clinical use. Regulation number: 862.2100 Classification: -Panel: Clinical Chemistry
1
4.0 Predicate device information
Manufacturer: Andon Health Co., Ltd. Device: iHealth BG3 Smart Gluco-Monitoring System 510(k) number: K120813
5.0 Device description
101 - 101 -
The iHealth BG1 Align Mini Gluco-Monitoring System (BGMS) consists of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.
The new device iHealth BG1 is 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 appearance of iHealth BG1 is different from the predicate device. Both the iHealth BG1 and the predicate device BG3 need to connect to iOS device to display the rest results, however, iHealth BG1 connect to iOS device through the earphone kack, while BG3 connect to iOS device through the 30-pin dock interface.
6.0 Intended use
The iHealth Align Mini Gluco-Monitoring system(BG1) 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
7- 2
2
The iHealth 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.
iHealth Blood Glucose Test Strips(AGS-1000I) are intended for use with the iHealth Align Mini Glucose meter (BG1) to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm,
forearm, upper arm, calf or thigh using the iHealth BG1 meter.
| NEW DEVICE: | PREDICATE: | |
|---|---|---|
| CHARACTERISTI | ||
| CS | iHealth BG1 Align Mini | |
| Gluco-Monitoring System | iHealth BG3 Smart | |
| Gluco-Monitoring System | ||
| (K120813) | ||
| Indication for Use | The iHealth Align Mini Gluco-Monitoring | |
| system(BG1) 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 | ||
| The iHealth 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. | iHealth BG3 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 | ||
| The iHealth BG3 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. | ||
| iHealth Blood Glucose Test | ||
| Strips(AGS-1000I) are intended for use | ||
| with the iHealth Align Mini Glucose meter | ||
| (BG1) to quantitatively measure glucose | ||
| in fresh capillary whole blood samples | ||
| drawn from the fingertips, palm, forearm, | ||
| upper arm, calf or thigh using the iHealth | ||
| BG1 meter. | The AGS1000I test strips are intended | |
| for use with the iHealth BG3 meter to | ||
| quantitatively measure glucose in fresh | ||
| capillary whole blood samples drawn | ||
| from the fingertips, palm, forearm, | ||
| upper arm, calf or thigh using the | ||
| iHealthBG3 meter | ||
| 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 | $10℃~35℃(50°-95°F)$ | $10℃~35℃(50°-95°F)$ |
| Range | ||
| Dimensions | 52mm×30mm×9.5mm | 102mm×58mm ×22mm |
| Display | Connect to iOS device to display | |
| measurement results | Connect to iOS device to display | |
| measurement results | ||
| Result | ||
| Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Memory | ||
| Capabilities | 10000 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 | DC3.0V (CR1620) | DC 3.3V (Powered by iOS device |
| connected to the meter) | ||
| Battery Life | 200 times testing | N/A |
| 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-1000I Test Strip | AGS-1000I Test Strip |
| Sample Volume | Minimum 0.7 micro liter | Minimum 0.7 micro liter |
| Connect Method | Connect to iOS device through | |
| Earphone jack | Connect to iOS device through 30-pin | |
| dock interface |
7.0 Summary comparing technological characteristics with predicate device
3
.
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·
4
8.0 Performance summary
The iHealth BG1 Align Mini 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.
Non-clinical test and the clinical test are done according to the above standard.
9.0 Comparison to the predict device and the conclusion
The iHealth BG1 is similar with the predicate device iHealth BG3, the two devices are both for single patient 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 two device is different,and both the two devices have no LCD display, they must be connected with iOS device, however, the connect methods are different, BG1 connect to iOS device through earphone jack, while BG3 connect to iOS device through 30-pin dock interface. iHealth BG1 use battery as power source, this is different from the predicate device BG3 which is powered by iOS device connected to the meter.
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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
May 22, 2014
ANDON HEALTH CO.. LTD MR YI LIU NO. 3 JIN PING STREET. YA AN ROAD. NANKAI DISTRICT TIANJIN. CHINA 300190
Re: K133790
Trade/Device Name: iHealth BG1 Align Mini Gluco-Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. CGA. JOP Dated: April 23, 2014 Received: April 25, 2014
Dear Mr. 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 docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
6
Page 2-Mr. Yi Liu
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, plcase 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincercly yours.
Courtney H. Lias -S
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K133790
Device Name
iHealth Align Mini Gluco-Monitoring System
Indications for Use (Describe)
The iHealth Align Gluco-Monitoring system(BG1) 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
from the fingertip, palm, forearm, upper arm, calf, or thigh.
a single person measurement only and should not be shared.
· 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
The iHealth 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.
iHealth Blood Glucose Test Strips(AGS-1000!) are intended for use with the iHealth Align Glucose meter (BG1) to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG1 meter.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Stavce Beck -S
. .