PRODIGY iConnect Blood Glucose Monitoring System

K142785 · Ok Biotech Co., Ltd. · NBW · Dec 17, 2015 · Clinical Chemistry

Device Facts

• Record ID: K142785
• Device Name: PRODIGY iConnect Blood Glucose Monitoring System
• Applicant: Ok Biotech Co., Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 17, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The PRODIGY iConnect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The PRODIGY iConnect Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The PRODIGY iConnect 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 PRODIGY iConnect Blood Glucose 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). PRODIGY No Coding Blood Glucose Test Strips are with the PRODIGY iConnect blood glucose meter to measure the concentration of blood glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh for self-testing at home. They are for testing outside the body (in vitro diagnostic use only). Do not use them for diagnosis of, or screening for diabetes or for testing on neonates. PRODIGY No Coding Blood Glucose Test Strips are used as an aid to monitor the effectiveness of diabetes control.

Device Story

System measures glucose in capillary whole blood via electrochemical biosensor; uses glucose oxidase enzyme on test strips. Meter detects electrical current proportional to glucose concentration; calculates and displays results in mg/dL or mmol/L. Designed for home use by patients with diabetes; single-patient use only. Includes meter, test strips, and control solutions. Features physical connectivity to mobile devices for data transmission to mobile app. Healthcare providers use output to assess diabetes management effectiveness. Benefits include convenient, rapid self-monitoring of blood glucose levels.

Clinical Evidence

Clinical performance evaluated in 350 lay users comparing capillary blood (fingertip, palm, forearm, upper arm, calf, thigh) to YSI 2300 laboratory reference. Results showed 100% of samples within ±15 mg/dL for glucose <75 mg/dL and 100% within ±20% for glucose >75 mg/dL across all sites. Bench testing confirmed precision, linearity (20-600 mg/dL), and robustness.

Technological Characteristics

Electrochemical biosensor with carbon electrodes; glucose oxidase enzyme. Dimensions: 48mm x 47mm x 13mm. Power: 3V CR2032 battery. Connectivity: physical connection to mobile devices. Operating range: 10-40°C, 10-85% RH. Hematocrit range: 20-60%. Measuring range: 20-600 mg/dL. Measuring time: 6 seconds.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from fingertips, forearm, upper arm, palm, calf, or thigh. For single-patient, home-use, in vitro diagnostic self-testing by people with diabetes to monitor glycemic control. Not for diagnosis/screening of diabetes or neonatal use. Alternative site testing restricted to steady-state glucose conditions.

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

• PRODIGY Preferred® Blood Glucose Monitoring System (K122338)

Submission Summary (Full Text)

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

December 17, 2015

OK BIOTECH CO., LTD. JEN KE-MIN OFFICIAL CORRESPONDENT NO. 91, SEC. 2, GONGDAO 5TH ROAD HSINCHU CITY 30070, TAIWAN

Re: K142785

Trade/Device Name: PRODIGY iConnect Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. CGA Dated: November 25, 2015 Received: December 8, 2015

Dear Jen Ke-min:

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.

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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

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# Indications for Use

510(k) Number (if known) K142785

### Device Name

PRODIGY iConnect Blood Glucose Monitoring System

## Indications for Use (Describe)

The PRODIGY iConnect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The PRODIGY iConnect Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The PRODIGY iConnect 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 PRODIGY iConnect Blood Glucose 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).

PRODIGY No Coding Blood Glucose Test Strips are with the PRODIGY iConnect blood glucose meter to measure the concentration of blood glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh for self-testing at home. They are for testing outside the body (in vitro diagnostic use only). Do not use them for diagnosis of, or screening for diabetes or for testing on neonates. PRODIGY No Coding Blood Glucose Test Strips are used as an aid to monitor the effectiveness of diabetes control.

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)

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Image /page/3/Picture/0 description: The image shows a logo for a company called "Kbiotech". The logo consists of a stylized letter "K" with circles around it, followed by the word "biotech" in a bold, italicized font. Below the company name is some text in Chinese characters. The logo is simple and modern, and the use of the letter "K" and the word "biotech" suggests that the company is involved in the biotechnology industry.

TEL : [phone] FAX : [phone] Taiwan : China : TEL : [phone] FAX : [phone]

> http://www.okbiotech.com E-mail:[e-mail]

# 5. 510(K) Summary of Safety and Effectiveness (Per 21 CFR 807.92)

| Type Of 510(K) Submission<br>Basis for the submission | Traditional<br>A New Device |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name Of The Proposed<br>Device | Blood Glucose Monitoring System |
| Trade name | PRODIGY iConnect Blood Glucose Monitoring<br>System |
| 510(K) Submitter | OK BIOTECH CO., LTD.<br>No. 91, Sec. 2, Gongdao 5th Road, 30070,<br>Hsinchu City, Taiwan<br>Telephone: [phone]<br>Fax:[phone]<br>Email: [e-mail] |
| Owner Number | 9090860 |
| Date prepared<br>Official Correspondent | December 16, 2015<br>Dr. JEN, KE-MIN<br>TEL: [phone]<br>FAX: [phone]<br>Email: [e-mail] |
| Preference For Continued<br>Confidentiality (21 CFR 807.95) | 510(k) Summary |
| Classification Regulation | SYSTEM, TEST, BLOOD GLUCOSE, OVER<br>THE COUNTER<br>(21 CFR 862.1345) |
| Class | II |
| Panel | Clinical Chemistry |
| Product Code | NBW, CGA |
| Predicate Device | PRODIGY Preferred® Blood Glucose<br>Monitoring System<br>(K122338) |

#### ● Intended Use:

The PRODIGY iConnect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The PRODIGY iConnect Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The PRODIGY iConnect 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 PRODIGY iConnect Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site

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Image /page/4/Picture/0 description: The image shows the logo for Kbiotech. The logo features a stylized letter K with a circular design around it, followed by the word "biotech" in a bold, sans-serif font. Below the word "biotech" is text in a different language, possibly Chinese or Japanese.

E-mail: [e-mail]

testing should be done only during steady - state times (when glucose is not changing rapidly).

PRODIGY No Coding Blood Glucose Test Strips are intended for use with the PRODIGY iConnect blood glucose meter to measure the concentration of blood glucose in fresh capillary whole blood samples drawn from the fingertips, forearm. upper arm, palm, calf or thigh for self-testing at home. They are for testing outside the body (in vitro diagnostic use only). Do not use them for diagnosis of, or screening for diabetes or for testing on neonates. PRODIGY No Coding Blood Glucose Test Strips are used as an aid to monitor the effectiveness of diabetes control.

#### ● Device Description:

The system is intended for use at home for single patient use. It should not be used for the diagnosis of diabetes or for the testing of newborns. It consists of three main components, i.e., iConnect blood glucose meter, PRODIGY No Coding Blood Glucose Test Strips and 2 levels of Prodigy control solutions (Level 1 & Level 2). The physical components of the meter are Housing, PCBA, LCD and Ear phone jack. The PRODIGY No Coding Blood Glucose Test Strips are not coded. The device has the function of alternative sites testing at Finger, Palm, Forearm, Upper arm, Calf and Thigh

The chemical makeup of the control solutions are as follows:

- 1. D-Glucose
- 2.. Antifoaming agent: 0.02%
- Food Pigment Red No. 6: 0.05% 3.
- 4. Non-reactive ingredients: 10.5%

The system has the ability of physically connecting to mobile devices for the purpose of obtaining blood glucose determination via a mobile APP.

The PRODIGY iConnect Blood Glucose Monitoring System is marketed as a meter only with a carrying case, battery, Meter User Guide, Quick Reference Guide, Logbook, and Warranty Card. The PRODIGY iConnect Blood Glucose Monitoring System is also marketed as a meter kit with a carrying case, battery, Meter User Guide, Quick Reference Guide, Logbook, Warranty Card, Prodigy Lancing Device, Prodigy Lancets, PRODIGY No Coding Blood Glucose Test Strips, and PRODIGY Control Solution.

If your iConnect blood glucose meter is being operated by a second person who is providing testing assistance to the user, the meter and lancing device should be disinfected prior to use by the second person. Consult your healthcare professional if unusual readings occur.

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Image /page/5/Picture/0 description: The image shows the logo for Kbiotech. The logo consists of a stylized letter K inside of an oval shape. The word "biotech" is written in bold letters to the right of the K. Below the word "biotech" is some text in another language.

#### ● Test Principle

Blood glucose is measured by an electrical current that is produced when a blood samples mixes with the reagent (special chemicals) of the test strip. The electrical current changes with the amount of glucose in the blood sample. The meter measures the strength of the electrical current, calculates your blood glucose level and then displays your result in either milligrams of glucose per deciliter (mg/dL) or millimoles of glucose per liter (mmol/L)

#### ● Comparison Table

| Comparison Items | Subject device | Predicate device | Safety and<br>effectiveness of<br>subject device<br>compared to the<br>predicate device |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| MANUFACTURER | OK Biotech Co., Ltd. | Prodigy Diabetes<br>LLC | OK Biotech is an<br>associate<br>manufacturer<br>with the Prodigy |
| BRAND NAME | Prodigy | Prodigy | Same brand<br>name |
| MODEL NO | iConnect | Preferred® | Different<br>models names |
| Trade Name | PRODIGY iConnect<br>Blood Glucose<br>Monitoring System | Prodigy Preferred® Blood<br>Glucose<br>Monitoring System | Different<br>Trade names |
| Similarities | | | |
| Product Code | NBW, CGA | NBW, CGA | Same product<br>code |
| 510K NO | K142785 | K122338 | Similar<br>submission |
| | The PRODIGY | The Prodigy | Similar |
| | iConnect Blood | Preferred Blood | indications for |
| | Glucose Monitoring | Glucose | use |
| | System is intended to | Monitoring | |
| | be used for the | System is | |
| | quantitative | intended to be | |
| | measurement of | used for the | |
| | glucose (sugar) in | quantitative | |
| | fresh capillary whole | measurement of | |
| | blood samples drawn | glucose (sugar) in | |
| | from the fingertips, | fresh capillary | |
| | forearm, upper arm, | whole blood | |
| | palm, calf or thigh. | samples drawn | |
| | The PRODIGY | from the | |
| | iConnect Blood | fingertips, | |
| | Glucose Monitoring | forearm, upper | |
| | System is intended to | arm, palm, calf or | |
| | be used by a single | thigh. The | |
| | person and should not | Prodigy Preferred | |
| | be shared. The | Blood Glucose | |
| | PRODIGY iConnect<br>Blood Glucose | Monitoring<br>System is | |
| | Monitoring System is | intended to be | |
| | intended for | used by a single | |
| Indications for use | self-testing outside the | person and should | |
| | body (in vitro | not be shared. | |
| | diagnostic use) by | The Prodigy | |
| | people with diabetes | Preferred Blood | |
| | at home as an aid to | Glucose | |
| | monitor the | Monitoring | |
| | effectiveness of | System is | |
| | diabetes control. The | intended for | |
| | PRODIGY iConnect | self-testing | |
| | Blood Glucose | outside the body | |
| | Monitoring System | (in vitro | |
| | should not be used for | diagnostic use) | |
| | the diagnosis of or | by people with | |
| | screening of diabetes | diabetes at home | |
| | or for neonatal use. | as an aid to | |
| | Alternative site testing | monitor the | |
| | should be done only | effectiveness of | |
| | during steady - state | diabetes control. | |
| | times (when glucose is | The Prodigy | |
| | not changing rapidly). | Preferred Blood | |
| | PRODIGY No | Glucose | |
| | Coding Blood | Monitoring | |
| | Glucose Test Strips | System should | |
| | are intended for use | not be used for | |
| | with the PRODIGY<br>iConnect blood<br>glucose meter to<br>measure the<br>concentration of<br>blood glucose in fresh<br>capillary whole blood<br>samples drawn from<br>the fingertips,<br>forearm, upper arm,<br>palm, calf or thigh for<br>self-testing at home.<br>They are for testing<br>outside the body (in<br>vitro diagnostic use<br>only). Do not use<br>them for diagnosis of,<br>or screening for<br>diabetes or for testing<br>on neonates.<br>PRODIGY No<br>Coding Blood<br>Glucose Test Strips<br>are used as an aid to<br>monitor the<br>effectiveness of<br>diabetes control. | the diagnosis of<br>or screening of<br>diabetes or for<br>neonatal use.<br>Alternative site<br>testing should be<br>done only during<br>steady -state<br>times (when<br>glucose is not<br>changing rapidly). | |
| Test Principle | Electrochemical<br>biosensor with carbon<br>electrodes | Electrochemical<br>biosensor with<br>carbon electrodes | Same principle |
| Enzyme | Glucose oxidase | Glucose oxidase | Same enzyme |
| Specimen Type | Capillary whole blood<br>from fingertip and<br>alternative sites (palm,<br>forearm, upper-arm,<br>calf and thigh) | Capillary whole<br>blood from<br>fingertip and<br>alternative sites<br>(palm, forearm,<br>upper-arm, calf<br>and thigh) | Same specimen<br>type |
| Test Strip | PRODIGY® No-<br>Coding Blood<br>Glucose Test Srtips | PRODIGY® No-<br>Coding Test | Same as previous<br>clearance<br>K122338 test |
| E-mail:[e-mail] | | | |
| | | Strips | strips |
| Control solution | PRODIGY® Control<br>Solutions (Level 1/<br>Level 2) | PRODIGY®<br>Control Solutions<br>(Level 1 / Level<br>2) | Same as previous<br>clearance<br>K122338<br>control solution |
| | Sample Volume | 0.7 µL | 0.7 µL |
| Operation<br>Conditions' | 10 - 40 °C<br>(39.2 - 104 °F),<br>10~85% R. H. | 10 - 40 °C<br>(39.2 - 104 °F),<br>10~85% R. H. | Same Operation<br>Conditions' |
| Strip Storage<br>conditions | 4 - 40 °C<br>(39.2 - 104 °F),<br>10~85% R. H. | 4 - 40 °C<br>(39.2 - 104 °F),<br>10~85% R. H. | Same strip<br>storage<br>conditions |
| HCT Range | 20 ~ 60 % | 20 ~ 60 % | Same HCT range |
| Detecting range | 20~600 mg/dL | 20~600 mg/dL | Same Detecting<br>range |
| Power Voltage | One 3V CR2032<br>battery | One 3V CR2032<br>battery | Same battery |
| Differences | | | |
| Measuring Time | 6 seconds…