iHealth Align Gluco-Monitoring system

K153286 · Andon Health Co, Ltd. · NBW · Aug 19, 2016 · Clinical Chemistry

Device Facts

• Record ID: K153286
• Device Name: iHealth Align Gluco-Monitoring system
• Applicant: Andon Health Co, Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The iHealth Align Gluco-Monitoring System consists of the iHealth Align Glucose meter (BG1), iHealth Blood Glucose Test Strips (AGS-1000I), and the iHealth Gluco-Smart App mobile application as the display component of the iHealth Align Gluco-Monitoring System. The iHealth Align Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Align Gluco-Monitoring System is intended to be used by a single person and should not be shared. The iHealth Align Gluco-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 iHealth Align Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

Device Story

System comprises BG1 meter, AGS-1000 test strips, and Gluco-Smart App. User lances skin (finger or alternative site), applies capillary blood to test strip. Meter uses electrochemical biosensor (glucose oxidase) and capillary action to measure glucose. Meter connects to iOS or Android mobile device via earphone jack; app displays results. Used by patients at home for diabetes management. Output (mg/dL or mmol/L) informs patient of glucose levels to monitor diabetes control. System stores up to 10,000 results.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and bench testing.

Technological Characteristics

Electrochemical biosensor (amperometry) using glucose oxidase. Dimensions: 52mm x 30mm x 9.5mm. Power: DC 3.0V (CR1620). Connectivity: Earphone jack interface to iOS/Android devices. Measurement range: 20-600 mg/dL. Hematocrit range: 20-60%. Sample volume: 0.7 µL. Test time: 5 seconds.

Indications for Use

Indicated for quantitative blood glucose measurement in people with diabetes at home to monitor diabetes control. For single-patient, in vitro diagnostic use. Not for neonatal use, diagnosis/screening of diabetes, or critically ill patients. Contraindicated for use with arterial blood, serum, or plasma; patients with severe dehydration, hypotension, or shock; or hyperglycemic-hyperosmolar states. Interference risks: acetaminophen >5 mg/dL, uric acid ≥10 mg/dL, ascorbic acid >2 mg/dL.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• iHealth BG1 Align Mini Gluco-Monitoring System (k133790)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/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, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted with three parallel lines forming the staff and the snakes, giving it a modern and abstract appearance.

Auqust 19, 2016

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

ANDON HEALTH CO., LTD LIU YI, PRESIDENT NO. 3 JINPING STREET, YA AN ROAD, NANKAI DISTRICT TIANJIN, P.R. CHINA

Re: K153286

Trade/Device Name: iHealth Align Gluco-Monitoring System (BG1) Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JQP Dated: August 11, 2016 Received: August 15, 2016

Dear Mr. Yi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

Page 2-Mr. Yi

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Stayce Beck -S

For :Courtney H. Lias Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

{2}------------------------------------------------

#### Indications for Use

510(k) Number (if known) k153286

Device Name

iHealth Align Gluco-Monitoring System (BG1)

#### Indications for Use (Describe)

The iHealth Align Gluco-Monitoring System consists of the iHealth Align Glucose meter (BG1), iHealth Blood Glucose Test Strips (AGS-1000), and the iHealth Gluco-Smart App mobile application as the display component of the iHealth Align Gluco-Monitoring System. The iHealth Align Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertin, upper arm, calf, or thigh. The iHealth Align Gluco-Monitoring System is intended to be used by a single person and should not be shared.

The iHealth Align Gluco-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 iHealth Align Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

Type of Use (Select one or both, as applicable)

| | Prescription Use (Part 21 CFR 801 Subpart D) |
|--|----------------------------------------------|
| | Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 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,<br>P.R. China |
| Phone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Yi Liu |
| Date of Preparation: | 11/05/2015 |

#### 2.0 Device information

| Trade name: | iHealth Align Gluco-Monitoring System (BG1 |
|----------------------|--------------------------------------------|
| 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

JQP Production code: Regulation number: 862.2100 Classification: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Panel: Clinical Chemistry

{4}------------------------------------------------

## 4.0 Predicate device information

| Manufacturer: | Andon Health Co., Ltd. |
|----------------|-------------------------------------------------|
| Device: | iHealth Align mini Gluco-Monitoring System(BG1) |
| 510(k) number: | K133790 |

## 5.0 Device description

The iHealth Align Gluco-Monitoring System(BG1) consist of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.

They are based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. It uses the same technological characteristics for testing with its predicate device.

In order to use the iHealth Align Gluco-Monitoring system(BG1) , a compatible Android or iOS mobile device with the necessary mobile application installed is required.

## 6.0 Intended use

The iHealth Align Gluco-Monitoring System consists of the iHealth Align Glucose meter (BG1), iHealth Blood Glucose Test Strips (AGS-1000), and the iHealth Gluco-Smart App mobile application as the display component of the iHealth Align Gluco-Monitoring System. The iHealth Align Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Align Gluco-Monitoring System is intended to be used by a single person and should not be shared.

The iHealth Align Gluco-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 iHealth Align Gluco-Monitoring System should not be used for the

{5}------------------------------------------------

diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

| CHARACTERISTICS | NEW DEVICE:<br>iHealth Align<br>Gluco-Monitoring<br>System(BG1) | PREDICATE:<br>iHealth BG1 Align mini<br>Gluco-Monitoring System<br>(K133790) |
|--------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Detection Method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase | Glucose Oxidase |
| Type of Meter | Biosensor (Electrode) | Biosensor (Electrode) |
| Sample Source | Capillary whole blood from<br>AST(Alternative site testing)<br>and finger | Capillary whole blood from<br>AST(Alternative site<br>testing) and finger |
| Sample Application | Blood sample is placed<br>directly to the test strip after<br>finger or AST is lanced. | Blood sample is placed<br>directly to the test strip<br>after finger or AST is<br>lanced. |
| Hematocrit Range | 20-60% | 20-60% |
| Operating<br>Temperature Range | 10℃~35℃(50°-95°F) | 10℃~35℃(50°-95°F) |
| Dimensions | 52mm×30mm×9.5mm | 52mm×30mm×9.5mm |
| Display | Connect to iOS device and<br>android device to display<br>measurement results | Connect to iOS device to<br>display measurement<br>results |
| Result Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Memory Capabilities | 10000 times with time and<br>date displaying | 10000 times with time and<br>date displaying |
| Test Start | Automatic | Automatic |
| Test Time | 5 second | 5 second |
| Power Source | DC3.0V (CR1620) | DC3.0V (CR1620) |
| Battery Life | N/A | N/A |
| Measurement Range | 20mg/dL-600mg/dL<br>(1.1mmol/L~33.3mmol/L) | 20mg/dL-600mg/dL<br>(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 and<br>Android device through<br>Earphone jack | Connect to iOS device<br>through Earphone jack |

## 7.0 Summary comparing technological characteristics with predicate device

{6}------------------------------------------------

#### 8.0 Comparison to the predict device and the conclusion

The proposed device is similar with the predicate device iHealth BG1, they 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. However, the proposed device can be connected to not only the iOS device, but also the Android device.

However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.