Prodigy® AutoCode® Eject 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® AutoCode® Eject Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Prodigy® AutoCode® Eject 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® AutoCode® Eject Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes, or for neonatal use. The alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

PRODIGY® No Coding Test Strips are intended for use with the PRODIGY® AutoCode® Eject blood glucose meter to measure the concentration of the 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 dabetes or for testing on neonates. PRODIGY® No Coding Test Strips are used as an aid to monitor the effectiveness of diabetes control.

This system contains a speaking function, but is not intended for use by the visually impaired.

Device Description

The Prodigy® AutoCode® Eject Blood Glucose Monitoring System consists of a meter and Prodigy No Coding Test Strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.

The Prodigy® AutoCode® Eject Blood Glucose Monitoring System is marketed as a meter only with a carrying case, batteries, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card.

The Prodigy® AutoCode® Eject Blood Glucose Monitoring System is also marketed as a meter kit with a carrying case, batteries, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card, Prodigy Lancing Device, Prodigy Lancets, Prodigy No Coding Test Strips, and Control Solution.

The Prodigy No Coding Test Strips utilizes the active enzyme is Glucose Oxidase, derived from Aspergillus niger. The Prodigy® AutoCode® Eject Blood Glucose Monitoring System has a speaking function.

AI/ML Overview

The provided text describes the Prodigy® AutoCode Eject TM Blood Glucose Monitoring System and its substantial equivalence to a predicate device. However, it does not contain the detailed study information (sample sizes, expertise, ground truth establishment) typically associated with acceptance criteria for an AI/ML medical device submission.

The document is a 510(k) summary for an in vitro diagnostic (IVD) device, specifically a blood glucose monitoring system, which measures glucose using an electrochemical method. These devices are generally tested against analytical and clinical performance standards rather than requiring AI-specific study designs like MRMC studies.

Here's a breakdown of the available information, noting the absence of AI/ML-specific details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the format of a table with specific thresholds for accuracy, precision, sensitivity, or specificity. Instead, it relies on demonstrating substantial equivalence to a predicate device (PRODIGY Preferred® Blood Glucose Monitoring System, K122338) that has already met regulatory requirements.

The "Synopsis of Test Methods and Results" section generally states that "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; Guidance for Industry and FDA document provided by CDRH/FDA." This indicates that standard analytical and clinical performance studies for blood glucose meters were conducted, but the specific results or acceptance criteria are not detailed in this summary.

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

This information is not provided in the document. The 510(k) summary only mentions that "Pre-clinical and clinical data are employed," but does not detail the sample size for any test sets or the provenance (country of origin, retrospective/prospective) of the data.

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

This information is not provided in the document. For blood glucose monitoring systems, ground truth is typically established by comparing the device's readings against a laboratory reference method (e.g., a YSI analyzer), not through expert consensus.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typical for interpreting subjective data (e.g., medical images) where human agreement is required to establish ground truth. For quantitative measurements like blood glucose, adjudication is not typically relevant at the point of establishing ground truth against a reference method.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or at least not reported in this 510(k) summary. These studies are specific to AI/ML devices that assist human readers in tasks like image interpretation. The Prodigy® AutoCode Eject TM Blood Glucose Monitoring System is a standalone diagnostic device that provides a direct quantitative measurement of glucose, not an AI assistant for human interpretation. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

The device itself is a standalone diagnostic device; its performance is inherently "algorithm only" in the sense that it measures glucose and provides a numerical output. However, it's not an AI/ML algorithm in the modern sense that often implies learning from data. It's an electrochemical system. The performance studies for such a device would inherently be standalone, evaluating the accuracy and precision of the meter and test strips.

7. The Type of Ground Truth Used

While not explicitly stated in this summary, for blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method, such as a YSI glucose analyzer, which is considered the gold standard for glucose measurement in clinical laboratories. This is a form of "objective measurement" or "pathology/reference method" rather than expert consensus or outcomes data.

8. The Sample Size for the Training Set

This information is not provided and is largely not applicable in the context of this device. The Prodigy® AutoCode Eject TM Blood Glucose Monitoring System is an electrochemical system, not an AI/ML device that requires a "training set" in the machine learning sense. Its underlying principle is a chemical reaction that generates an electrical current proportional to glucose, not a model trained on data.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable for the reasons stated above (not an AI/ML device requiring a training set).

In summary, the provided document describes a traditional in-vitro diagnostic blood glucose meter. The request for information regarding AI/ML-specific study design elements (MRMC, training sets, number of experts, adjudication) is not directly addressed because the device is not an AI/ML medical device. The 510(k) process for such devices focuses on demonstrating substantial equivalence to a legally marketed predicate device by showing similar indications for use, technological characteristics, and comparable safety and effectiveness through "pre-clinical and clinical data" (analytical and clinical performance studies, which are not detailed in this summary).

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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines that suggest the shape of a human profile.

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

April 15, 2015

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

Re: K141914

Trade/Device Name: Prodigy® Autocode Eject TM Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. CGA Dated: March 1, 2015 Received: March 11, 2015

Dear Ke-min Jen:

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,

Stayce Beck -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) K141914

Device Name

PRODIGY® AutoCode Eject TM Blood Glucose Monitoring System

Indications for Use (Describe)

This system contains a speaking function, but is not intended for use by the visually impaired.

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 with the letter K inside of an oval shape. Next to the K is the word "Kbiotech" in a stylized font. Below the logo is text in a non-English language, possibly Chinese or Taiwanese. The text appears to be the name of the company.

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) Submission	Traditional
Basis for the submission	A New Device
Common Name Of The ProposedDevice	Blood Glucose Monitoring System
Trade name	PRODIGY AutoCode Eject™ Blood GlucoseMonitoring System
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 prepared	April 14, 2015
Official Correspondent	Dr. JEN, KE-MINTEL: 886-3-5208829 FAX: 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
Predicate Device	PRODIGY Preferred® Blood Glucose MonitoringSystem

● Intended Use:

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Image /page/4/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 is a line of text in a different language, possibly Chinese or Japanese, indicating the company's name or description. The logo appears to be for a biotechnology company, given the use of the term 'biotech'.

E-mail:service@okbiotech.com

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

PRODIGY® No Coding Test Strips are intended for use with the PRODIGY® AutoCode® Eject blood glucose meter to measure concentration the 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 Test Strips are used as an aid to monitor the effectiveness of diabetes control.

This system contains a speaking function, but is not intended for use by the visually impaired.

● Device Description:

The Prodigy® AutoCode® Eject Blood Glucose Monitoring System is marketed as a meter only with a carrying case, batteries, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card.

● Test Principle

The Blood glucose test is based on the measurement of electrical current generated by the reaction of capillary whole blood glucose with glucose oxidase on the test strip. The meter measures the strength of the current which is proportional to the concentration of glucose present and displays the corresponding blood glucose level.

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Image /page/5/Picture/0 description: The image shows the logo for Kbiotech. The logo features a stylized letter K enclosed in a circular design, 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.

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

● Comparison Table

Comparison Items	Subject device	Predicate device
MANUFACTURER	OK Biotech Co., Ltd.	Prodigy Diabetes Care, LLC
BRAND NAME	Prodigy	Prodigy
Model Number	AutoCode EjectTM	Preferred®
Trade Name	Prodigy® AutoCode EjectTMBlood Glucose MonitoringSystem	Prodigy Preferred® BloodGlucose Monitoring System
Product Code	NBW	NBW
510K NO	K141914	K122338
Similarities
Indications for use	Prodigy® AutoCode® EjectBlood Glucose MonitoringSystem is intended to be usedfor the quantitativemeasurement of glucose (sugar)in fresh capillary whole bloodsamples drawn from thefingertips, forearm, upper arm,	The Prodigy Preferred BloodGlucose Monitoring System isintended to be used for thequantitative measurement ofglucose (sugar) in freshcapillary whole blood samplesdrawn from the fingertips,forearm, upper arm, palm, calf
	Prodigy® AutoCode® EjectBlood Glucose MonitoringSystem is intended to be usedby a single person and shouldnot be shared. The Prodigy®AutoCode® Eject BloodGlucose Monitoring System isintended for self-testing outsidethe body (in vitro diagnosticuse) by people with diabetes athome as an aid to monitor theeffectiveness of diabetescontrol. The Prodigy®AutoCode® Eject BloodGlucose Monitoring Systemshould not be used for thediagnosis of, or screening fordiabetes, or for neonatal use.The alternative site testingshould be done only duringsteady-state times (whenglucose is not changingrapidly).PRODIGY® No Coding TestStrips are intended for use withthe PRODIGY® AutoCode®Eject blood glucose meter tomeasure concentration the ofblood glucose in fresh capillarywhole blood samples drawnfrom the fingertips, forearm,upper arm, palm, calf or thighfor self-testing at home. Theyare for testing outside the body(in vitro diagnostic use only) .Do not use them for diagnosisof, or screening for diabetes orfor testing on neonates.PRODIGY® No Coding TestStrips are used as an aid tomonitor the effectiveness ofdiabetes control.This system contains aspeaking function, but is notintended for use by the visuallyimpaired.	E-mail:service@okbiotech.comBlood Glucose MonitoringSystem is intended to be usedby a single person and shouldnot be shared.The Prodigy Preferred BlondGlucose Monitoring System isintended for self testing outsidethe body (in vitro diagnosticuse) by people with diabetes athome as an aid to monitor theeffectiveness of diabetescontrol. The Prodigy PreferredBlood Glucose MonitoringSystem should not be used forthe diagnosis of or screening ofdiabetes or for neonatal use.Alternative site testing shouldbe done only during steady-state times (when glucose isnot changing rapidly).
Test Principle	The test is based on the	Same
current generated by thereaction of capillary wholeblood glucose with glucoseoxidase on the test strip. Themeter measures the strengthof the current which isproportional to theconcentration of glucosepresent and displays thecorresponding blood glucoselevel.		E-mail:service@okbiotech.com
Enzyme	Glucose oxidase	Same
Specimen Type	Capillary whole blood fromfingertip and alternative sites(palm, forearm, upper-arm, calfand thigh)	Same
Test Strip	PRODIGY® No-Coding TestStrips	Same
Control solution	PRODIGY® Control Solution(Level 1 & Level 2)	Same
Sample Volume	0.7 μL	Same
OperatingTemperature	50 °F - 104 °F10~85% R. H.	Same
Strip StorageTemperature	39.2 - 104 °F10~85% R. H.	Same
HCT Range	20 ~ 60 %	Same
Detecting range	20~600 mg/dL	same
code-checkingmechanism	Code number checking	Same
temperaturecompensationmechanism	Automatic compensation withbuilt-in thermistor	Same
Differences
Measuring Time	6 seconds	7 seconds
Meter size	100 mm (L) × 56 mm (W) × 23	71 mm (L) × 60 mm (W) × 19
	mm (H)	mm (H)
Meter Weight	Approximate 79 g (w/ battery)	Approximate 45 g (w/battery)
Power Battery	1.5V AAA Alkaline battery x2	One 3V CR2032 battery
Memory Storage	450 tests	120 tests
Speaking feature	Yes	No

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Image /page/6/Picture/0 description: The image shows a logo for "Kbiotech". The logo features a stylized letter "K" enclosed in a circular design, with the word "biotech" written in bold, italicized letters next to it. Below the word "biotech", there is some text in a different language, possibly Chinese, which could be the company's name or a slogan.

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 'biotech' stacked on top of each other. The 'K' is stylized with a circular design around it. Below the word 'biotech' is text in a different language, possibly Chinese, indicating the company's name or description. The logo appears to represent a company named 'Kbiotech'.

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

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Image /page/8/Picture/0 description: The image shows a logo with the letter K inside a circular design. Next to the logo is the word "biotech" in bold, followed by Chinese characters. The logo appears to represent a company or organization named "Kbiotech".

TEL : 886-3-5160258 FAX : 886-3-5160028 Taiwan : TEL : 86-791-3899362 FAX : 86-791-388013 China :

http://www.okbiotech.co

● Substantial Equivalence (SE) Discussion

A claim of substantial equivalence is made to PRODIGY Preferred® Blood Glucose Monitoring System (K122338). Both of them have the same indications for use, the same working principle and technologies including using the same Prodigy No-Coding test strips and PRODIGY Control Solution, sample volume, operating & storage conditions, HCT range, detecting range.

The major differences for the two devices are measuring time, meter dimensions, meter weight; power battery, memory storage, and speaking feature The speaking function for the subject device is indicated not to be used by visually impaired person, just an aid for all of the users. The subject device and predicate device are intended for use 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. They are substantially equivalent.

● 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; 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.