FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems

K161738 · Taidoc Technology Corporation · NBW · Nov 10, 2016 · Clinical Chemistry

Device Facts

• Record ID: K161738
• Device Name: FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 10, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

FORA ADVANCED GD40 Blood Glucose and β-Ketone Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger, and for the quantitative measurement of β-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger. The FORA ADVANCED GD40 is intended for in vitro diagnostic use and is intended for single-patient use as an aid to monitor the effectiveness of a diabetes control program. The system should not be used for the diagnosis of or screening for diabetes. FORA ADVANCED GD40 Blood Glucose Test Strips are for use with the FORA ADVANCED GD40 Blood Glucose and β-Ketone Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the finger. The FORA ADVANCED GD40 Blood β-Ketone Test Strips are for use with the FORA ADVANCED GD40 Blood Glucose and β-Ketone Meter to quantitatively measure β-ketone in fresh capillary whole blood samples drawn from the finger. β-Ketone Control Solutions are intended for use with FORA ADVANCED GD40 Blood Glucose and β-Ketone Monitoring System as a quality control check to verify the accuracy of blood ketone test results. FORA ADVANCED GD40 pro Blood Glucose and β-Ketone Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger, and from venous, and neonatal whole blood, and for the quantitative measurement of β-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger, and from venous whole blood. The FORA ADVANCED GD40 pro is intended for 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. This system should only be used with single-use, auto-disabling lancing devices. The system should not be used for the diagnosis of or screening for diabetes. FORA ADVANCED GD40 pro Blood Glucose Test Strips are for use with the FORA ADVANCED GD40 pro Blood Glucose and β-Ketone Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, and from venous and neonatal whole blood. The FORA ADVANCED GD40 pro Blood β-Ketone Test Strips are for use with the FORA ADVANCED GD40 pro Blood Glucose and β-Ketone Meter to quantitatively measure β-ketone in fresh capillary whole blood samples drawn from the fingertips and from venous whole blood. β-Ketone Control Solutions are intended for use with FORA ADVANCED GD40 pro Blood Glucose and β-Ketone Monitoring System as a quality control check to verify the accuracy of blood ketone test results.

Device Story

System uses electrochemical biosensor technology to measure glucose and β-ketone concentrations in whole blood samples. Input: capillary, venous, or neonatal blood applied to test strips via capillary action. Operation: glucose dehydrogenase (FAD) catalyzes glucose oxidation; β-hydroxybutyrate dehydrogenase catalyzes β-ketone conversion; resulting electrical current is proportional to analyte concentration. Output: quantitative glucose (mg/dL) or β-ketone (mmol/L) values displayed on meter. GD40 intended for single-patient home use; GD40 pro intended for multiple-patient professional healthcare settings. Healthcare providers use results to monitor diabetes control effectiveness. Benefits include rapid, point-of-care monitoring of glycemic and ketotic status.

Clinical Evidence

Performance evaluated in laboratory and clinical settings by healthcare professionals and lay users. Studies confirm that intended users obtain glucose and beta-ketone results substantially equivalent to current standard methods.

Technological Characteristics

Electrochemical biosensor; enzymatic reaction (Glucose Dehydrogenase/beta-hydroxybutyrate dehydrogenase); capillary/venous/neonatal whole blood samples; meter-based display; calibrated to plasma glucose equivalents; includes test strips and control solutions.

Indications for Use

Indicated for quantitative measurement of glucose and β-ketone in fresh capillary whole blood (finger), venous, and neonatal whole blood (GD40 pro only). Intended as an aid to monitor diabetes control programs. Contraindicated for diagnosis/screening of diabetes, patients in shock, severe hypotension, hyperglycemic-hyperosmolar state, or critically ill patients.

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

• Nova Max Plus Blood Glucose and β-Ketone Monitor System (K091547)

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 features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

November 10, 2016

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

# TAIDOC TECHNOLOGY CORPORATION PAUL LIU SENIOR REGULATORY AFFAIRS SPECIALIST 6F, NO.127, WUGONG 2ND RD., WUGU DISTRICT NEW TAIPEI CITY 24888, TAIWAN

Re: K161738

Trade/Device Name: FORA ADVANCED GD40 Blood Glucose and ß-Ketone Monitoring System

> FORA ADVANCED GH40 pro Blood Glucose and ß-Ketone Monitoring System

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JIN, JJX Dated: September 26, 2016 Received: October 3, 2016

Dear Paul 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 Parts 801 and 809); medical device 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

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

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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,

Katherine Serrano -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

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

# Indications for Use

510(k) Number (if known)

## Device Name

FORA ADVANCED GD40 Blood Glucose and ß-Ketone Monitoring System

## Indications for Use (Describe)

FORA ADVANCED GD40 Blood Glucose and p-Ketone Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger, and for the quantitative measurement of [0-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger. The FORA ADVANCED GD40 is intended for in vitro diagnostic use and is intended for single-patient use as an aid to monitor the effectiveness of a diabetes control program. The system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.

FORA ADVANCED GD40 Blood Glucose Test Strips are for use with the FORA ADVANCED GD40 Blood Glucose and ß-Ketone Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the finger. The FORA ADVANCED GD40 Blood 8-Ketone Test Strips are for use with the FORA ADVANCED GD40 Blood Glucose and 0-Ketone Meter to quantitatively measure 0-ketone in fresh capillary whole blood samples drawn from the finger.

ß-Ketone Control Solutions are intended for use with FORA ADVANCED GD40 Blood Glucose and ß-Ketone Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly.

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)

## 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)

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

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."

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

# Indications for Use

510(k) Number (if known)

## Device Name

FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring System

## Indications for Use (Describe)

FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger, and neonatal capillary heelstick whole blood, and for the quantitative measurement of [3-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger, and from venous whole blood. The FORA ADVANCED GD40 pro is intended for 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. This system should only be used with single-use, auto-disabling lancing devices. The system should not be used for the diagnosis of or screening for diabetes.

FORA ADVANCED GD40 pro Blood Glucose Test Strips are for use with the FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, and from venous and neonatal whole blood. The FORA ADVANCED GD40 pro Blood β-Ketone Test Strips are for use with the FORA ADVANCED GD40 pro Blood Glucose and p-Ketone Meter to quantitatively measure fketone in fresh capillary whole blood samples drawn from the fingertips and from venous whole blood.

ß-Ketone Control Solutions are intended for use with FORA ADVANCED GD40 Blood Glucose and ß-Ketone Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly.

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)

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

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."

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

Image /page/6/Picture/0 description: The image shows the logo for TaiDoc, a company that specializes in medical devices. The logo features the company name in gray, with three red hearts underneath. Below the hearts is the company's website address, www.taidoc.com, in white text on a gray background.

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The Assigned 510(k) number is:

# 1. Submitter Information

| Company Name: | TaiDoc Technology Corporation |
|-----------------|-------------------------------------------------------------------------------|
| Contact Person: | Paul Liu |
| Title: | Regulatory Affairs Specialist |
| Address: | B1-7F, No. 127, Wugong 2nd Rd., Wugu District, New Taipei City, 24888, Taiwan |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Prepared Date: | June 19th, 2016 |

# 2. Regulatory information:

| Proprietary Name: | FORA ADVANCED GD40 Blood Glucose and β-Ketone<br>Monitoring System<br>FORA ADVANCED GD40 pro Blood Glucose and β-Ketone<br>Monitoring System<br>β-Ketone Control Solution |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Blood Glucose and β-Ketone Monitoring System |
| Product Code: | NBW - Blood Glucose Test System, Over-the-Counter<br>LFR - Glucose Dehydrogenase<br>JIN - nitroprusside, ketones (urinary, non-quant.)<br>JJX - single (specified) analyte controls (assayed and unassayed) |
| Classification Panel: | 75, Clinical chemistry |
| Classification: | Class II (glucose)<br>Class I (β-Ketone) |
| Regulation Citation: | 21 CFR §862.1345. Glucose test system |

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for TaiDoc. The logo consists of the word "TaiDoc" in gray, followed by three red hearts in a row. Below the hearts is a gray rectangle with the text "www.taidoc.com" in white.

21 CFR 862.1435 Ketones (nonquantitative) test system 21 CFR 862.1660 Quality control material (assayed and unassayed)

# 3. Predicate Device

Nova Max Plus Blood Glucose and B-Ketone Monitor System (k091547)

# 4. Intended Use

# Single-patient use

FORA ADVANCED GD40 Blood Glucose and β-Ketone Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger, and for the quantitative measurement of ß-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger. The FORA ADVANCED GD40 is intended for in vitro diagnostic use and is intended for single-patient use as an aid to monitor the effectiveness of a diabetes control program. The system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.

FORA ADVANCED GD40 Blood Glucose Test Strips are for use with the FORA ADVANCED GD40 Blood Glucose and ß-Ketone Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the finger. The FORA ADVANCED GD40 Blood ß-Ketone Test Strips are for use with the FORA ADVANCED GD40 Blood Glucose and ß-Ketone Meter to quantitatively measure ß-ketone in fresh capillary whole blood samples drawn from the finger.

ß-Ketone Control Solutions are intended for use with FORA ADVANCED GD40 Blood Glucose and B-Ketone Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for TaiDoc. The logo consists of the word "TaiDoc" in gray font, followed by three red hearts. Below the logo is the website address "www.taidoc.com" in white font on a gray background.

Multiple-patient use

泰博科技股份有限公司 aiDoc Technology Corp.

新北市24888石股區五工二路1 Jew Tainei City 24888 Taiwar

Fax · [phone]

FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger, and from venous, and neonatal capillary heelstick whole blood, and for the quantitative measurement of ß-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger, and from venous whole blood. The FORA ADVANCED GD40 pro is intended for 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. This system should only be used with single-use, auto-disabling lancing devices. The system should not be used for the diagnosis of or screening for diabetes.

FORA ADVANCED GD40 pro Blood Glucose Test Strips are for use with the FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, and from venous and neonatal whole blood. The FORA ADVANCED GD40 pro Blood ß-Ketone Test Strips are for use with the FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Meter to quantitatively measure ß-ketone in fresh capillary whole blood samples drawn from the fingertips and from venous whole blood.

ß-Ketone Control Solutions are intended for use with FORA ADVANCED GD40 Pro Blood Glucose and ß-Ketone Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly.

### 5. Device Description:

The FORA ADVANCED GD40/GD40 Pro Blood Glucose and ß-Ketone Monitoring System consists of: FORA ADVANCED GD40/GD40 Pro Blood Glucose and ß-Ketone Meter (same as meter cleared under k101509, with addition of ketone testing capability), FORA ADVANCED GD40/GD40 Pro Glucose Test Strips, FORA Glucose Control Solutions (cleared under K093724), FORA ADVANCED GD40/GD40 Pro β-Ketone Test Strips, and ß-Ketone Control Solutions.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the TaiDoc logo. The logo consists of the word "TaiDoc" in gray, with three red hearts below it. Below the hearts is the website address "www.taidoc.com" in white text on a gray background. The logo is simple and clean, with the hearts adding a touch of warmth.

#### 6. Comparison to the Predicate:

The FORA ADVANCED GD40/GD40 Pro Blood Glucose and ß-Ketone Monitoring System uses the same fundamental technology and has same intended use as the predicate device Nova Max Plus Blood Glucose and B-Ketone Monitor System (k091547).

### Test Principle : 7.

Glucose measurement is based on electrochemical biosensor technology using the enzyme Glucose Dehydrogenase to catalyze the formation of gluconolactone from the oxidation of glucose whereby two electrons are produced. The electrical current resulting from this enzymatic reaction is measured and correlated to glucose concentration by the meter. The magnitude of the current is proportional to the concentration of glucose in the sample. The test strip is calibrated to display the equivalent of plasma glucose values to allow comparison of results with laboratory methods. Using the same technology, B-hydroxybutyrate (B-ketone) is converted by B-hydroxybutyrate dehydrogenase and the magnitude of electrical current resulting from this enzymatic reaction is proportional to the amount of ß-hydroxybutyrate present in the sample.

The ß-ketone control solution contain known amount of ß-hydroxybutyrate that reacts with ß-ketone test strip intended for use as quality checks.

### 8. Performance Studies:

The performance of the FORA ADVANCED GD40/GD40 Pro Blood Glucose and ß-Ketone Monitoring System was studied in the laboratory and clinical settings by healthcare professionals and lay users. The studies demonstrate that the intended users can obtained blood Glucose and ß-Ketone results that are substantially equivalent to the current methods for blood glucose and ß-Ketone measurement.

### 9. Conclusion:

Based on the results of laboratory and clinical studies provided in this submission, FORA ADVANCED GD40/GD40 Pro Blood Glucose and ß-Ketone Monitoring System is substantially equivalent to the predicate devices.