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 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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the PRODIGY iConnect Blood Glucose Monitoring System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Criteria Category	Acceptance Criteria	Reported Device Performance
Robustness	Individual bias of test results compared with YSI mean: < 10 mg/dL at glucose concentrations < 75 mg/dL; < ± 10% at glucose concentrations ≥ 75 mg/dL after 3,650 cleaning/disinfection cycles.	Individual bias of the test results compared with YSI mean were less than 10 mg/dL at glucose concentrations < 75 mg/dL and less than ± 10% at glucose concentrations ≥ 75 mg/dL. The test results met acceptance criteria.
Precision (Within-run & Between-run)	Pooled Standard Deviation < 5.0 mg/dL at glucose concentration < 100 mg/dL; Pooled Coefficient of Variation < 5.0% at glucose concentration ≥ 100 mg/dL, compared to YSI reference standards over ten days.	Pooled Standard Deviation less than 5.0 mg/dL at glucose concentration < 100 mg/dL, and pooled Coefficient of Variation less than 5.0% at glucose concentration ≥ 100 mg/dL for within runs and between runs compared to the YSI reference standards over the course of ten days. The test results met the acceptance criteria.
Linearity	Correlation coefficient > 0.95. 100% of individual glucose results bias within ±10% within the measuring range of 20 to 600 mg/dL.	Correlation coefficient is greater than 0.95 (Lot I: 0.9997, Lot II: 0.9998, Lot III: 0.9999). 100% of the bias of individual glucose results fallen within ±10%. The linearity of measurement is acceptable between 20 to 600 mg/dL. The test results met the acceptance criteria.
System Accuracy	For glucose concentrations < 75 mg/dL: ≥95% of results within ±15 mg/dL. For glucose concentrations ≥ 75 mg/dL: ≥95% of results within ±20%.	For glucose concentrations < 75 mg/dL: ≥96.9% of tests for which the differences fell within ±15 mg/dL (Finger: 100%, Palm: 100%, Forearm: 100%, Upper Arm: 100%, Calf: 100%, Thigh: 100%). For glucose concentrations ≥ 75 mg/dL: 100% within 20% (Finger: 100%, Palm: 100%, Forearm: 100%, Upper Arm: 100%, Calf: 100%, Thigh: 100%). The test results met the acceptance criteria.
Hematocrit Evaluation	Individual difference of blood glucose measurements compared with individual YSI mean fall within ±15% from HCT 20% to 60%. % bias difference on mean value of blood glucose measurements fall within 8% compared with mean of blood glucose measurements in HCT 40% from HCT 20% to 60%.	All of the individual difference of the blood glucose measurements compared with individual YSI mean fall within ±15% from HCT 20% to 60%. Also, % bias difference on mean value of the blood glucose measurements fall within 8% compared with the mean of blood glucose measurements in HCT 40% from HCT 20% to 60%. The test results met the acceptance criteria.
Interference Study	Bias of mean test results within the listed ranges ≤ 10% compared with the YSI mean measurements. The concentration limits of all interfering substances higher than therapeutic or physiological levels.	Bias of mean test results within the range listed above were ≤ 10% compared with the YSI mean measurements. No obvious interference was observed in the interfering substance at neither therapeutic nor physiological levels at three blood glucose levels. The test results met the acceptance criteria.
Operation Condition	Confirmed operation within temperature range of 4 - 40 °C and relative humidity range of 10~85%.	The study confirmed the operation conditions for the temperature range of 4 - 40 °C (39.2 - 104 °F), and the relative humidity range of 10~85%.
Sample Volume	Test values of volumes between 0.7 and 1.5 uL fall within acceptable criteria. Requires at least 0.7 uL of blood sample.	The test values of volumes between 0.7 and 1.5 uL were fall within acceptable criteria. It's required at least 0.7 uL of blood sample. The test results met the acceptance criteria.
Virucide Evaluation	Complete inactivation of Hepatitis B Virus at specified dilutions on case & lens coupons within 2 minutes contact time using PDI SUPER SANI-CLOTH germicidal disposable wipes.	PDI SUPER SANI-CLOTH germicidal disposable wipes (EPA Reg. No. 9480-4) within 2 minutes contact time can completely inactivate the Hepatitis B Virus at undiluted (HBsAg: 7857.9 IU/mL), 10X, 100X and 1000X virus dilution on the Case & Lens coupons.
Altitude Study	Individual results fall within ± 10% at altitude below 11,161 feet (3,402 meters).	The individual results fall within ± 10% at the altitude below 11,161 feet (3,402 meters). The results met the acceptance criteria. So it shows no significant effects on PRODIGY iConnect Blood Glucose Monitoring System at the altitudes below 11,161 feet (3,402 meters).
Mechanical Resistance	Meters can withstand vibration and drop testing required by ISO 15197:2013, IEC 60068-2-64:1993, and IEC 61010-1:2010.	All studies showed the meters could stand the vibration and drop testing required in ISO 15197:2013, IEC 60068-2-64:1993 and IEC 61010-1: 2010.
Shelf-Life Study	Unused test strips stable for 25 months; 96 days for opened vials.	The unused test strips were stable for 25 months and 96 days for opened vials. The shelf-life of PRODIGY Blood Glucose Test Strip is claimed as 24 months for unopened strips vials and 90 days for opened strips vials. All data met the acceptance criteria.
Software V&V	Device performs as intended based on Software Design Specifications, hazards mitigated.	All software documentation prepared and submitted, tested against specifications. Device Hazard Analysis completed and risk control implemented. Testing results support all software specifications met acceptance criteria of each module and interaction of processes. V&V with HTC and Apple platforms demonstrated safety and effectiveness.
Electrical Safety	Complies with IEC 60601-1: 2005, IEC 61010-1:2010, IEC 61010-2-101:2002, FCC 47 CFR Part 15 Subpart B/Oct. 2013 and CISPR 22/1997 (Class B Limit).	The device with Apple or HTC platform passed all the electrical safety testing according to national & international standards including IEC 60601-1: 2005, IEC 61010-1:2010, IEC 61010-2-101:2002, FCC 47 CFR Part 15 Subpart B/Oct. 2013 and CISPR 22/1997 (Class B Limit).
EMC	Complies with IEC 60601-1-2:2007, IEC 61326-1:2012, IEC 61326-2-6:2005, CISPR 11:2009 +A1:2010 Class B, IEC 61000-4-2:2008, IEC 61000-4-3:2010, IEC 61000-4-8:2009 for radiated emissions, electrostatic discharge, radio-frequency electromagnetic immunity, and power frequency magnetic field immunity.	The PRODIGY iConnect Blood Glucose Monitoring System with Apple or HTC platform has been tested and successfully met all of the relevant sections (Radiated Emissions, Electrostatic Discharge Immunity Test, Radiated Radio-Frequency Electromagnetic Immunity, and Power Frequency Magnetic Field Immunity Test to complies to all standards including IEC 60601-1-2:2007: Electromagnetic Compatibility, IEC 61326-1:2012, IEC 61326-2-6:2005, Emission: CISPR 11:2009 +A1:2010, Class B, Immunity: IEC 61000-4-2:2008, IEC 61000-4-3:2010, IEC 61000-4-8:2009.

2. Sample Size Used for the Test Set and Data Provenance

System Accuracy Evaluation (Lay Persons Study): 350 lay persons.
- Data Provenance: The document does not explicitly state the country of origin. It indicates "internal test results" and a study involving "lay persons," but no geographical specifics are provided. It does not mention whether it was retrospective or prospective. It is implied to be prospective for the lay persons study.
Precision Evaluation: Tested over the blood glucose concentration range of 20-600 mg/dL and Control Levels 1 and 2 over the course of ten days. (Specific number of samples/runs not detailed, but standard deviations/CVs derived).
Linearity Evaluation: Not specified exact number of samples, but used different lots of test strips (Lot I, Lot II, Lot III).
Hematocrit Evaluation: Evaluated over an HCT range of 20-60%.
Interference Study: "Ten meters and three lots of test strips were used for this study." Samples were venous blood spiked with various substances at three glucose levels (60, 120, 250 mg/dL).
Robustness Evaluation: Ten iConnect meters for vibration and drop tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not explicitly mention the use of experts to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method as external expert review for ground truth was not explicitly stated. The ground truth was established by a reference method (YSI).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance.

This device is a blood glucose monitoring system, not an imaging device requiring human "readers" or AI assistance in interpretation in the context of MRMC studies common in radiology or pathology. Therefore, an MRMC comparative effectiveness study of human readers with/without AI assistance was not performed or applicable in the way described. The device is for direct quantitative measurement.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done.

Yes, the studies performed (Precision, Linearity, System Accuracy, Hematocrit, Interference, etc.) evaluate the standalone performance of the PRODIGY iConnect Blood Glucose Monitoring System. The device directly measures glucose concentration without human interpretation of its output that would significantly alter the result. The software verification and validation also represent standalone algorithmic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for accuracy studies (System Accuracy, Precision, Linearity, Hematocrit, Interference) was established using a YSI reference standard (specifically, implies the YSI 2300 Glucose Analyzer, which is a common and highly accurate laboratory reference method for glucose measurement).

8. The sample size for the training set

The document does not specify a separate "training set" sample size. For medical devices, particularly for quantitative measurement systems, "training" in the machine learning sense is often not distinct in the same way as for AI image analysis. Instead, the devices are designed and then validated against established standards. The development and internal testing phases would involve data, but it's not typically compartmentalized as a "training set" in regulatory submissions for this type of device.

9. How the ground truth for the training set was established

As there's no explicitly defined "training set" in the context of machine learning, the establishment of ground truth for general device development and calibration would similarly rely on highly accurate laboratory reference methods like the YSI and adherence to standards (e.g., ISO 15197).

Summary

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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)

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)

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 PRAStaff(@fda.hhs.gov

"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."

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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 : 886-3-5160258 FAX : 886-3-5160028 Taiwan : China : TEL : 86-791-3899362 FAX : 86-791-3880131

http://www.okbiotech.com E-mail:service@okbiotech.com

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

Type Of 510(K) SubmissionBasis for the submission	TraditionalA New Device
Common Name Of The ProposedDevice	Blood Glucose Monitoring System
Trade name	PRODIGY iConnect Blood Glucose MonitoringSystem
510(K) Submitter	OK BIOTECH CO., LTD.No. 91, Sec. 2, Gongdao 5th Road, 30070,Hsinchu City, TaiwanTelephone: +886-3-516-0258Fax:+886-3-516-0028Email: service@okbiotech.com
Owner Number	9090860
Date preparedOfficial Correspondent	December 16, 2015Dr. JEN, KE-MINTEL: 886-3-5208829FAX: 886-3-5209783Email: ceirs.jen@msa.hinet.net
Preference For ContinuedConfidentiality (21 CFR 807.95)	510(k) Summary
Classification Regulation	SYSTEM, TEST, BLOOD GLUCOSE, OVERTHE COUNTER(21 CFR 862.1345)
Class	II
Panel	Clinical Chemistry
Product Code	NBW, CGA
Predicate Device	PRODIGY Preferred® Blood GlucoseMonitoring System(K122338)

● Intended Use:

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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: service@okbiotech.com

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

● Device Description:

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.
1. 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.

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 andeffectiveness ofsubject devicecompared to thepredicate device
MANUFACTURER	OK Biotech Co., Ltd.	Prodigy DiabetesLLC	OK Biotech is anassociatemanufacturerwith the Prodigy
BRAND NAME	Prodigy	Prodigy	Same brandname
MODEL NO	iConnect	Preferred®	Differentmodels names
Trade Name	PRODIGY iConnectBlood GlucoseMonitoring System	Prodigy Preferred® BloodGlucoseMonitoring System	DifferentTrade names
Similarities
Product Code	NBW, CGA	NBW, CGA	Same productcode
510K NO	K142785	K122338	Similarsubmission
	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 iConnectBlood Glucose	MonitoringSystem 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 PRODIGYiConnect bloodglucose meter tomeasure theconcentration ofblood glucose in freshcapillary whole bloodsamples drawn fromthe fingertips,forearm, upper arm,palm, calf or thigh forself-testing at home.They are for testingoutside the body (invitro diagnostic useonly). Do not usethem for diagnosis of,or screening fordiabetes or for testingon neonates.PRODIGY NoCoding BloodGlucose Test Stripsare used as an aid tomonitor theeffectiveness ofdiabetes control.	the diagnosis ofor screening ofdiabetes or forneonatal use.Alternative sitetesting should bedone only duringsteady -statetimes (whenglucose is notchanging rapidly).
Test Principle	Electrochemicalbiosensor with carbonelectrodes	Electrochemicalbiosensor withcarbon electrodes	Same principle
Enzyme	Glucose oxidase	Glucose oxidase	Same enzyme
Specimen Type	Capillary whole bloodfrom fingertip andalternative sites (palm,forearm, upper-arm,calf and thigh)	Capillary wholeblood fromfingertip andalternative sites(palm, forearm,upper-arm, calfand thigh)	Same specimentype
Test Strip	PRODIGY® No-Coding BloodGlucose Test Srtips	PRODIGY® No-Coding Test	Same as previousclearanceK122338 test
E-mail:service@okbiotech.com
		Strips	strips
Control solution	PRODIGY® ControlSolutions (Level 1/Level 2)	PRODIGY®Control Solutions(Level 1 / Level2)	Same as previousclearanceK122338control solution
	Sample Volume	0.7 µL	0.7 µL
OperationConditions'	10 - 40 °C(39.2 - 104 °F),10~85% R. H.	10 - 40 °C(39.2 - 104 °F),10~85% R. H.	Same OperationConditions'
Strip Storageconditions	4 - 40 °C(39.2 - 104 °F),10~85% R. H.	4 - 40 °C(39.2 - 104 °F),10~85% R. H.	Same stripstorageconditions
HCT Range	20 ~ 60 %	20 ~ 60 %	Same HCT range
Detecting range	20~600 mg/dL	20~600 mg/dL	Same Detectingrange
Power Voltage	One 3V CR2032battery	One 3V CR2032battery	Same battery
Differences
Measuring Time	6 seconds	7 seconds	less measuringtime
Meter size	48 mm (L) × 47 mm(W) × 13 mm (H)	71 mm (L) × 60mm (W) × 19 mm(H)	Smaller metersize
	Meter Weight	Approximate 20 g(with battery)	Approximate 45 g(with battery)
Average calculation	Not applicable	7-, 14-, 21-and 28- days	No averagecalculation
	Memory Storage	100 tests	120 tests

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Image /page/6/Picture/0 description: The image shows the logo for Kbiotech. The logo consists of a stylized letter K inside a circle, followed by the word "biotech" in a bold, sans-serif font. Below the word "biotech" 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.

Taiwan : TEL : 886-3-5160258 FAX : 886-3-5160028 China: TEL:86-791-3899362 FAX:86-791-3880131

http://www.okbiotech.com E-mail:service@okbiotech.com

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Image /page/7/Picture/0 description: The image contains a logo with the letters 'K' and 'b' intertwined, followed by the word 'biotech' in a bold, sans-serif font. Below the word 'biotech', there are Chinese characters, which likely represent the name of the company or organization associated with the logo. The logo appears to be for a biotechnology company.

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Image /page/8/Picture/0 description: The image shows a logo with the letters 'Kb' stacked on top of each other. To the right of the letters is the word 'biotech' in a bold, sans-serif font. Below the logo is some text in a different language, possibly Chinese or Japanese. The logo appears to be for a biotechnology company.

Taiwan : TEL : 886-3-5160258 FAX : 886-3-5160028 China : TEL:86-791-3899362 FAX:86-791-3880131

http://www.okbiotech.com E-mail:service@okbiotech.com

● Substantial Equivalence (SE) Discussion

A claim of substantial equivalence is made to PRODIGY Preferred® Blood

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Image /page/9/Picture/0 description: The image shows a 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 some text in a different language, possibly Chinese or Japanese. The logo appears to be for a company in the biotechnology industry.

E-mail:service@okbiotech.com

Glucose Monitoring System (K122338). Both of them have the similar indications for use, the same working principle and technologies, including using the same Prodigy No-Coding test strips and PRODIGY Control Solutions, same enzyme, same specimen type, same sample volume, same operating & strip storage conditions, same HCT range, same detecting range, and same battery.

The major differences for the two devices are measuring time, meter size, meter weight; average calculation and memory storage. The smaller meter size and smaller meter weight of the subject device bring more convenient carrying capability to users. Measuring time has only one second difference, and subject device is faster than the predicate device, thus having better performance. Average calculation and memory storage are different. Since the blood glucose measuring data vary much because of the user's diet status, the meaning of average calculation is not significant. The memory storage is 100-set data for the subject device and 120 sets for the predicate device. The meaning of the memory storage is for user's recalling reference and 20 sets difference is not significant for recall, thus not raising any safety and effectiveness concerns.

Besides, the subject device and predicate device have the same intended uses in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. Thus the differences are due to the feature design aspects, not related to the safety or effectiveness aspects.

● Summary of the Non-Clinical Performance Characteristics

The following non-clinical testing were conducted on the PRODIGY iConnect Blood Glucose Monitoring System to show substantial equivalence to the predicate device:

Software verification and validation testing (IEC 62304:2006, FDA Guidance, 5/2005)
Electromagnetic Compatibility Study (IEC 60601-1-2:2007: Electromagnetic Compatibility, IEC 61326-1:2012, IEC 61326-2-6:2005, Emission: CISPR 11:2009 +A1:2010. Class B. Immunity: IEC 61000-4-2:2008, IEC 61000-4-3:2010, IEC 61000-4-8:2009
. Electrical Safety testing (IEC 60601-1: 2005, IEC 61010-1:2010, IEC 61010-2-101:2002, FCC 47 CFR Part 15 Subpart B/Oct. 2013 and CISPR 22/1997 (Class B Limit)
. Robustness Evaluation (FDA Guidance, Jan/2014)
Precision Evaluation (FDA Guidance 02/28/1997, ISO 15197:2013, NCCLS EP5-A2)
Linearity Evaluation (NCCLS/CLSI, EP6-A, FDA Guidance 02/28/1997, ISO 15197:2013)
. System Accuracy Evaluation (ISO 15197:2013, FDA Guidance 02/28/1997)
. Hematocrit Evaluation (FDA Guidance 02/28/1997, ISO 15197:2013,)

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Image /page/10/Picture/0 description: The image shows the logo for Kbiotech. The logo consists of a stylized letter K inside of a circle, with the word "biotech" written in bold letters to the right of the K. Below the word biotech is some text in a different language.

. Interference Study (FDA Guidance 02/28/1997, ISO 15197:2013, CLSI EP7-A2)
. Operation Condition Study (ISO 15197:2013, EN 13640)
Sample Volume Study (ISO 15197:2013)
Virucide Evaluation for Case & Lens materials (CLSI EP17-A)
Altitude Study (FDA Guidance 02/28/1997, ISO 15197:2013)
I Mechanical Resistance Study (ISO 15197:2013, IEC 60068-2-64:1993, IEC 61010-1:2010)
I Shelf-Life Study (ISO 15197:2013)

Testing demonstrated the PRODIGY iConnect Blood Glucose Monitoring System meets all relevant standards requirements. Internal verification and validation testing confirms that the product specifications are met which are equivalent in design and technological characteristics to the predicate device. Testing of the PRODIGY iConnect Blood Glucose Monitoring System supports the claims of substantial equivalence to the predicate device.

Software: All software documentation was prepared and submitted for the device in accordance with FDA guidance documents. The software was tested against the established Software Design Specifications for each of the test plans to assure the device performs as intended. The Device Hazard Analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria of each module and interaction of processes. The PRODIGY iConnect Blood Glucose Meter and APP software verification and validation with HTC and Apple platforms demonstrated safety and effectiveness of the PRODIGY iConnect Blood Glucose Monitoring System.

Electrical safety: The PRODIGY iConnect Blood Glucose Monitoring System complies with the applicable voluntary standards for the Electrical Safety. The device with Apple or HTC platform passed all the electrical safety testing according to national & international standards including IEC 60601-1: 2005, IEC 61010-1:2010, IEC 61010-2-101:2002, FCC 47 CFR Part 15 Subpart B/Oct. 2013 and CISPR 22/1997 (Class B Limit).

Electromagnetic Compatibility The PRODIGY iConnect Blood Glucose Monitoring System with Apple or HTC platform has been tested and successfully met all of the relevant sections (Radiated Emissions, Electrostatic Discharge Immunity Test, Radiated Radio-Frequency Electromagnetic Immunity, and Power Frequency Magnetic Field Immunity Test to complies to all standards including IEC Electromagnetic Compatibility, I IEC 61326-1:2012, I 60601-1-2:2007: IEC 61326-2-6:2005, Emission: CISPR 11:2009 +A1:2010, Class B, Immunity: IEC 61000-4-2:2008, IEC 61000-4-3:2010, IEC 61000-4-8:2009.

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Image /page/11/Picture/0 description: The image shows a logo with the letter K inside of a circular design. Next to the K is the word "Kbiotech" in a stylized font. Below the logo is some text in a different language.

E-mail:service@okbiotech.com

Robustness Study: The PRODIGY iConnect Blood Glucose Monitoring System is intended for single-patient use. According to the study results with the use of PDI SUPER SANI-CLOTH germicidal disposable wipes (EPA Reg. No. 9480-4), the appearance, structure and function of the meters and the lancing device were quite regular after cleaning and disinfection cycles 3,650 times. Also, based on the accuracy test, all the individual bias of the test results compared with YSI mean were less than 10 mg/dL at glucose concentrations < 75 mg/dL and less than ± 10 % at glucose concentrations ≥ 75 mg/dL. The test results met acceptance criteria. The subject device passes the Robustness Study.

Precision Evaluation: The PRODIGY iConnect Blood Glucose Monitoring System was evaluated in accordance with FDA Guidance 02/28/1997. NCCLS EP5-A User Evaluation of Precision Performance of Clinical Chemistry Devices and ISO 15197:2013. The subject device within-run and between-run tests over the blood glucose concentration range of 20-600 mg/dL and Control Levels 1 and 2 showed the pooled Standard Deviation were less than 5.0 mg/dL at glucose concentration < 100 mg/dL, and pooled Coefficient of Variation were less than 5.0% at glucose concentration ≥ 100 mg/dL for within runs and between runs compared to the YSI reference standards over the course of ten days. The test results met the acceptance criteria. The subject device passes the Precision Evaluation.

Linearity Evaluation: The PRODIGY iConnect Blood Glucose Monitoring System was tested to determine the linearity in accordance with CLSI document EP6-A, "Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach" and ISO 15197: 2003. The PRODIGY iConnect Blood Glucose Monitoring System was shown to demonstrate high linearity over the range 10.46 mg/dL to 672.9 mg/dL. The claimed blood glucose measuring range is 20 to 600 mg/dL, same as the predicate device. Linear regression showed the correlation coefficient is greater than 0.95, as shown in the following Table. That is, our test results were highly correlated with YSI 2300. The linearity of our measurement is acceptable between 20 to 600 mg/dL. 100 % of the bias of individual glucose results fallen within ±10 %. The test results met the acceptance criteria. The subject device passes the Linearity Evaluation.

Test Strip Lot	Slope	y-intercept	R2
Lot I	1.0001	-0.8111	0.9997

Table: The separate regression analysis for each lot of test strips

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Image /page/12/Picture/0 description: The image contains a logo with the letters 'Kb' in a stylized font, with the word 'biotech' written in a smaller font next to it. Below the logo, there is some text in a different language, possibly Chinese or Japanese. The logo appears to be for a biotechnology company.

Taiwan : TFI : 886-3-5160258 FAX : 886-3 China :

http://www.dkbiotech.co

Lot II	1.0036	-3.0874	0.9998
Lot III	1.0026	-2.1376	0.9999

System Accuracy Evaluation: The PRODIGY iConnect Blood Glucose Monitoring System was evaluated for system accuracy using YSI as the reference standard. According to the internal test results, ≥96.9% of tests for which the differences fell within ±15 mg/dL for glucose concentration <75 mg/dL, and 100% within 20% at glucose concentration ≥75 mg/dL. A study evaluating glucose values from fingertip, palm, forearm, upper arm, calf, and thigh capillary blood samples obtained by 350 lay persons showed the following results. The test results of PRODIGY iConnect Blood Glucose Monitoring System met the acceptance criteria. The subject device passes the System Accuracy Evaluation.

Site	Within ± 5 mg/dL	Within ± 10 mg/dL	Within ± 15 mg/dL
Finger	18/32 (56.3%)	31/32 (96.9%)	32/32 (100%)
Palm	16/32 (50.0%)	30/32 (93.8%)	30/32 (100%)
Forearm	21/32 (65.6%)	31/32 (96.9%)	31/32 (100%)
Upper arm	24/32 (75.0%)	32/32 (100%)	32/32 (100%)
Calf	18/32 (56.3%)	31/32 (96.9%)	31/32 (100%)
Thigh	15/32 (46.9%)	31/32 (96.9%)	31/32 (100%)

For glucose concentrations < 75 mg/dL

For glucose concentrations ≥ 75 mg/dL

Site	Within ± 5 %	Within ± 10 %	Within ± 15 %	Within ± 20 %
Finger	150/318(47.2%)	251/318(78.9%)	310/318(97.5%)	318/318(100%)
Palm	158/318(49.7%)	262/318(82.4%)	309/318(97.2%)	318/318(100%)
Forearm	160/318(50.3%)	256/318(80.5%)	311/318(97.8%)	318/318(100%)
Upper arm	137/318(43.1%)	247/318(77.7%)	302/318(95.0%)	318/318(100%)
Calf	159/318(50.0%)	257/318(80.8%)	312/318(98.1%)	318/318(100%)
Thigh	131/318(41.2%)	241/318(75.8%)	305/318(95.9%)	318/318(100%)

Hematocrit Evaluation: The effect of varying hematocrit (HCT) levels on the performance of the PRODIGY iConnect Blood Glucose Monitoring System was evaluated over an HCT range of 20-60%. All of the individual difference of the blood

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Image /page/13/Picture/0 description: The image contains a logo for Kbiotech. The logo features a stylized letter "K" enclosed in a circular shape, followed by the word "biotech" in a bold, sans-serif font. Below the word "biotech" is a line of text in a different language, possibly Chinese or Japanese.

E-mail:service@okbiotech.com

glucose measurements compared with individual YSI mean fall within ±15% from HCT 20% to 60%. Also, % bias difference on mean value of the blood glucose measurements fall within 8% compared with the mean of blood glucose measurements in HCT 40% from HCT 20% to 60%. The test results met the acceptance criteria. In summary, the HCT ranges from 20% to 60% were available for PRODIGY iConnect Blood Glucose Monitoring System.

Interference Study: The interference study was completed per CLSI EP7-A2: Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition. Interference studies were performed on the PRODIGY iConnect Blood Glucose Monitoring System and PRODIGY No-Coding Blood Glucose Test Strips. Seven endogenous and nineteen exogenous interfering substances were evaluated by spiking venous blood to three levels of glucose concentrations (60, 120, 250 mg/dL). The glucose samples were then spiked with the potentially interfering compounds. Ten meters and three lots of test strips were used for this study. Bias was calculated as the mean percent difference in glucose reading between the test and control concentration groups. The bias of mean test results within the range listed above were ≤ 10% compared with the YSI mean measurements. Based on the results, the concentration limits of all the interfering substances were higher than therapeutic or physiological levels. That is, no obvious interference was observed in the interfering substance at neither therapeutic nor physiological levels at three blood glucose levels. A summary of the maximum concentrations of the potential interfering substances tested is summarized in the table below:

Chemical	Max
	Concentration
1. Acetaminophen	< 8.0 mg/dL
2. Ascorbic acid	< 5.0 mg/dL
3. Aspirin	< 60 mg/dL
4. Bilirubin (unconjugated)	< 90 mg/dL
5. Cholesterol	< 500 mg/dL
6. Creatinine	< 5.0 mg/dL
7. Dopamine	< 2.0 mg/dL
8. EDTA	<360 mg/dL
9. Galactose	< 900 mg/dL
10. Gentisic acid	< 5.0 mg/dL
11. Glutathione	<53 mg/dL
12. Haemoglobin	<500 mg/dL
13. Heparin	<8000 U/dL
14. Hydroxyurea	< 3.0 mg/dL
15.Ibuprofen	<50 mg/dL
16. Icodextrin	<13 mg/dL
17. L-dopa	< 10 mg/dL
18. Maltose	< 900 mg/dL
19. Methyldopa	< 3.0 mg/dL
20. Pralidoxime Iodide	<25 mg/dL
21. Salicylate	<60 mg/dL

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Image /page/14/Picture/0 description: The image shows the logo for Kbiotech. The logo features a stylized letter K enclosed in a circular shape, with the word "biotech" written in bold, sans-serif font to the right of the K. Below the word "biotech" is some text in a different language.

22. Tolazamide	$\leq$ 100 mg/dL
23. Tolbutamide	$\leq$ 400 mg/dL
24. Triglyceride	$\leq$ 2000 mg/dL
25. Uric acid	$\leq$ 8.0 mg/dL
26. Xylose	$\leq$ 100 mg

Operation Condition Study: This study confirmed the operation conditions of the PRODIGY iConnect Blood Glucose Monitoring System for the temperature range of 4 - 40 ℃ (39.2 - 104 °F), and the relative humidity range of 10~85%.

Sample Volume Study: Based on the data evaluation, the test values of volumes between 0.7 and 1.5 uL were fall within acceptable criteria. In order to obtain more accurate results, testing blood glucose value with the PRODIGY iConnect Blood Glucose Monitoring System is required at least 0.7 uL of blood sample.

Virucide Evaluation for Case & Lens materials: The study indicated that PDI SUPER SANI-CLOTH germicidal disposable wipes (EPA Reg. No. 9480-4) within 2 minutes contact time can completely inactivate the Hepatitis B Virus at undiluted (HBsAg: 7857.9 IU/mL), 10X, 100X and 1000X virus dilution on the Case & Lens coupons.

Altitude Study: The study shows the individual results fall within ± 10 % at the altitude below 11,161 feet (3,402 meters). The results met the acceptance criteria. So it shows no significant effects on PRODIGY iConnect Blood Glucose Monitoring System at the altitudes below 11,161 feet (3,402 meters).

Mechanical Resistance Study: The PRODIGY iConnect Blood Glucose Monitoring System was examined to test the operational limits of the system and to validate the insensitivity of the system to performance variation under stress conditions. Accordingly, the following tests were carried out:

1. Vibration test: Ten iConnect meters were subjected respectively to vibration tester for 30 min for X axis, 30 min for Y axis and 30 min for Z axis, then doing the blood glucose measurement with 3 lots of test strips.
1. Drop test: Ten iConnect meters are released respectively from 1 meter high above a horizontal hardwood, then doing the blood glucose measurement with 3 lots of test strips.

All studies showed the meters could stand the vibration and drop testing required in ISO 15197:2013, IEC 60068-2-64:1993 and IEC 61010-1: 2010.

Shelf-Life Study: According to the test result, all the data met the acceptance criteria. That is, the unused test strips were stable for 25 months and 96 days for opened vials. We can claim the shelf-life of PRODIGY Blood Glucose Test Strip is 24 months for unopened strips vials and 90 days for opened strips vials.

Synopsis of Test Methods and Results

Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System;

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Image /page/15/Picture/0 description: The image shows the logo for Kbiotech. The logo features a stylized letter K with a circle around it, followed by the word "biotech" in a smaller font. Below the English text is Chinese text, which is likely the company's name in Chinese. The logo is simple and modern, and it is likely used on the company's website and marketing materials.

Guidance for Industry and FDA document provided by CDRH/ FDA.

● Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus the subject device is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.