PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM

• K Number: K141914
• Device Name: PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer: OK BIOTECH CO., LTD.
• Date Cleared: 2015-04-15 ( 274 days)
• Product Code: NBW
• Regulation Number: 862.1345

Intended Use

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.

Predicate Devices

K122338

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard electrochemical blood glucose monitoring system and does not mention any AI or ML components.

Therapeutic

No
The device is used for the quantitative measurement of glucose, aiding in monitoring the effectiveness of diabetes control. It is for "in vitro diagnostic use" and explicitly states it "should not be used for the diagnosis of, or screening for diabetes." These characteristics indicate it is a diagnostic or monitoring device, not a therapeutic device which would directly treat a condition.

Diagnostic

No

The text explicitly states: "The Prodigy® AutoCode® Eject Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes, or for neonatal use." While it measures glucose, its intended use is for monitoring effectiveness of diabetes control rather than initial diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of a meter and test strips, which are hardware components. It also mentions a lancing device and lancets as part of a kit.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The Prodigy® AutoCode® Eject Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use)..." and "They are for testing outside the body (in vitro diagnostic use only)".
• Definition of IVD: An IVD is a medical device used to examine specimens, such as blood, taken from the human body to provide information for diagnosis, monitoring, or screening. This device fits this definition by measuring glucose in blood samples.
• Purpose: The system is intended to measure glucose in blood samples to aid in monitoring the effectiveness of diabetes control, which is a diagnostic and monitoring purpose.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

NBW. CGA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

fingertips, forearm, upper arm, palm, calf or thigh

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Home use by people with diabetes, self-testing.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key 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. 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K122338

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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

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

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

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

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

Sincerely yours,

Stayce Beck -S

For : Courtney H. Lias, 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)

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.

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.

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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 : [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	Traditional
Basis for the submission	A New Device
Common Name Of The Proposed
Device	Blood Glucose Monitoring System
Trade name	PRODIGY AutoCode Eject™ Blood Glucose
Monitoring System
510(K) Submitter	OK BIOTECH CO., LTD.
No. 91, Sec. 2, Gongdao 5th Road, 30070,
Hsinchu City, Taiwan
Telephone: [phone]
Fax:[phone]
Email: [e-mail]
Owner Number	9090860
Date prepared	April 14, 2015
Official Correspondent	Dr. JEN, KE-MIN
TEL: [phone] FAX: [phone]
Email: [e-mail]
Preference For Continued
Confidentiality (21 CFR 807.95)	510(k) Summary
Classification Regulation	SYSTEM, TEST, BLOOD GLUCOSE, OVER
THE COUNTER
(21 CFR 862.1345)
Class	II
Panel	Clinical Chemistry
Product Code	NBW
Predicate Device	PRODIGY Preferred® Blood Glucose Monitoring
System

● Intended Use:

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,

4

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:[e-mail]

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 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.

● 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:[e-mail]

● 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 EjectTM
Blood Glucose Monitoring
System	Prodigy Preferred® Blood
Glucose Monitoring System
Product Code	NBW	NBW
510K NO	K141914	K122338
Similarities
Indications for use	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,	The Prodigy Preferred 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
	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 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.	E-mail:[e-mail]
Blood Glucose Monitoring
System is intended to be used
by a single person and should
not be shared.
The Prodigy Preferred Blond
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 Preferred
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).
Test Principle	The test is based on the	Same
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.		E-mail:[e-mail]
Enzyme	Glucose oxidase	Same
Specimen Type	Capillary whole blood from
fingertip and alternative sites
(palm, forearm, upper-arm, calf
and thigh)	Same
Test Strip	PRODIGY® No-Coding Test
Strips	Same
Control solution	PRODIGY® Control Solution
(Level 1 & Level 2)	Same
Sample Volume	0.7 μL	Same
Operating
Temperature	50 °F - 104 °F
10~85% R. H.	Same
Strip Storage
Temperature	39.2 - 104 °F
10~85% R. H.	Same
HCT Range	20 ~ 60 %	Same
Detecting range	20~600 mg/dL	same
code-checking
mechanism	Code number checking	Same
temperature
compensation
mechanism	Automatic compensation with
built-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:[e-mail]

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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:[e-mail]

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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 : [phone] FAX : [phone] Taiwan : TEL : [phone] FAX : [phone] 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.