(447 days)
No
The summary describes a standard blood glucose monitoring system that measures glucose levels using test strips. There is no mention of AI, ML, or any advanced algorithms beyond basic measurement and data display. The connection to a mobile app appears to be for data transfer, not for AI/ML processing of the glucose data itself.
No
The device is a blood glucose monitoring system, which is used for measurement and monitoring, not for therapy or treatment.
Yes
The PRODIGY iConnect Blood Glucose Monitoring System is explicitly stated as being for "in vitro diagnostic use" and functions as an "aid to monitor the effectiveness of diabetes control," which are characteristics of a diagnostic device.
No
The device description explicitly states it consists of three main components: iConnect blood glucose meter, PRODIGY No Coding Blood Glucose Test Strips, and Prodigy control solutions. It also lists physical components of the meter (Housing, PCBA, LCD, Ear phone jack) and mentions non-clinical testing including electrical safety and mechanical resistance, indicating it is a hardware device with accompanying software.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use statement explicitly states: "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 description of the PRODIGY No Coding Blood Glucose Test Strips also states: "They are for testing outside the body (in vitro diagnostic use only)."
These statements clearly indicate that the device is intended for use on samples taken from the human body but tested outside of the body to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PRODIGY iConnect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The PRODIGY iConnect Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The PRODIGY iConnect Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The PRODIGY iConnect Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
PRODIGY No Coding Blood Glucose Test Strips are 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.
Product codes
NBW, CGA
Device Description
The system is intended for use at home for single patient use. It should not be used for the diagnosis of diabetes or for the testing of newborns. It consists of three main components, i.e., iConnect blood glucose meter, PRODIGY No Coding Blood Glucose Test Strips and 2 levels of Prodigy control solutions (Level 1 & Level 2). The physical components of the meter are Housing, PCBA, LCD and Ear phone jack. The PRODIGY No Coding Blood Glucose Test Strips are not coded. The device has the function of alternative sites testing at Finger, Palm, Forearm, Upper arm, Calf and Thigh
The chemical makeup of the control solutions are as follows:
-
- D-Glucose
- 2.. Antifoaming agent: 0.02%
- Food Pigment Red No. 6: 0.05% 3.
-
- Non-reactive ingredients: 10.5%
The system has the ability of physically connecting to mobile devices for the purpose of obtaining blood glucose determination via a mobile APP.
The PRODIGY iConnect Blood Glucose Monitoring System is marketed as a meter only with a carrying case, battery, Meter User Guide, Quick Reference Guide, Logbook, and Warranty Card. The PRODIGY iConnect Blood Glucose Monitoring System is also marketed as a meter kit with a carrying case, battery, Meter User Guide, Quick Reference Guide, Logbook, Warranty Card, Prodigy Lancing Device, Prodigy Lancets, PRODIGY No Coding Blood Glucose Test Strips, and PRODIGY Control Solution.
If your iConnect blood glucose meter is being operated by a second person who is providing testing assistance to the user, the meter and lancing device should be disinfected prior to use by the second person. Consult your healthcare professional if unusual readings occur.
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 (not for neonatal use)
Intended User / Care Setting
People with diabetes at home, single person use, self-testing outside the body (in vitro diagnostic use).
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)
- Software verification and validation testing: The software was tested against established Software Design Specifications, confirming performance as intended. Device Hazard Analysis completed, and risk control implemented. Testing results support that all software specifications met acceptance criteria. The PRODIGY iConnect Blood Glucose Meter and APP software verification and validation with HTC and Apple platforms demonstrated safety and effectiveness.
- Electromagnetic Compatibility Study: The PRODIGY iConnect Blood Glucose Monitoring System with Apple or HTC platform passed all relevant sections (Radiated Emissions, Electrostatic Discharge Immunity Test, Radiated Radio-Frequency Electromagnetic Immunity, and Power Frequency Magnetic Field Immunity Test) and complies with all listed standards.
- Electrical Safety testing: The device with Apple or HTC platform passed all electrical safety testing according to national & international standards.
- Robustness Evaluation: Study showed that appearance, structure, and function of meters and lancing device were regular after 3,650 cleaning and disinfection cycles. Accuracy test results met acceptance criteria (individual bias 0.95. 100 % of the bias of individual glucose results fell within ±10 %. Results met acceptance criteria.
- System Accuracy Evaluation: Using YSI as reference standard, ≥96.9% of tests for which the differences fell within ±15 mg/dL for glucose concentration
§ 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.
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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.
1
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
2
Indications for Use
510(k) Number (if known) K142785
Device Name
PRODIGY iConnect Blood Glucose Monitoring System
Indications for Use (Describe)
The PRODIGY iConnect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The PRODIGY iConnect Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The PRODIGY iConnect Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The PRODIGY iConnect Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
PRODIGY No Coding Blood Glucose Test Strips are with the PRODIGY iConnect blood glucose meter to measure the concentration of blood glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh for self-testing at home. They are for testing outside the body (in vitro diagnostic use only). Do not use them for diagnosis of, or screening for diabetes or for testing on neonates. PRODIGY No Coding Blood Glucose Test Strips are used as an aid to monitor the effectiveness of diabetes control.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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)
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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
5. 510(K) Summary of Safety and Effectiveness (Per 21 CFR 807.92)
| Type Of 510(K) Submission
Basis for the submission | Traditional
A New Device |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name Of The Proposed
Device | Blood Glucose Monitoring System |
| Trade name | PRODIGY iConnect Blood Glucose Monitoring
System |
| 510(K) Submitter | OK BIOTECH CO., LTD.
No. 91, Sec. 2, Gongdao 5th Road, 30070,
Hsinchu City, Taiwan
Telephone: +886-3-516-0258
Fax:+886-3-516-0028
Email: service@okbiotech.com |
| Owner Number | 9090860 |
| Date prepared
Official Correspondent | December 16, 2015
Dr. JEN, KE-MIN
TEL: 886-3-5208829
FAX: 886-3-5209783
Email: ceirs.jen@msa.hinet.net |
| 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, CGA |
| Predicate Device | PRODIGY Preferred® Blood Glucose
Monitoring System
(K122338) |
● Intended Use:
The PRODIGY iConnect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The PRODIGY iConnect Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The PRODIGY iConnect Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The PRODIGY iConnect Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site
4
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).
PRODIGY No Coding Blood Glucose Test Strips are intended for use with the PRODIGY iConnect blood glucose meter to measure the concentration of blood glucose in fresh capillary whole blood samples drawn from the fingertips, forearm. upper arm, palm, calf or thigh for self-testing at home. They are for testing outside the body (in vitro diagnostic use only). Do not use them for diagnosis of, or screening for diabetes or for testing on neonates. PRODIGY No Coding Blood Glucose Test Strips are used as an aid to monitor the effectiveness of diabetes control.
● Device Description:
The system is intended for use at home for single patient use. It should not be used for the diagnosis of diabetes or for the testing of newborns. It consists of three main components, i.e., iConnect blood glucose meter, PRODIGY No Coding Blood Glucose Test Strips and 2 levels of Prodigy control solutions (Level 1 & Level 2). The physical components of the meter are Housing, PCBA, LCD and Ear phone jack. The PRODIGY No Coding Blood Glucose Test Strips are not coded. The device has the function of alternative sites testing at Finger, Palm, Forearm, Upper arm, Calf and Thigh
The chemical makeup of the control solutions are as follows:
-
- D-Glucose
- 2.. Antifoaming agent: 0.02%
- Food Pigment Red No. 6: 0.05% 3.
-
- Non-reactive ingredients: 10.5%
The system has the ability of physically connecting to mobile devices for the purpose of obtaining blood glucose determination via a mobile APP.
The PRODIGY iConnect Blood Glucose Monitoring System is marketed as a meter only with a carrying case, battery, Meter User Guide, Quick Reference Guide, Logbook, and Warranty Card. The PRODIGY iConnect Blood Glucose Monitoring System is also marketed as a meter kit with a carrying case, battery, Meter User Guide, Quick Reference Guide, Logbook, Warranty Card, Prodigy Lancing Device, Prodigy Lancets, PRODIGY No Coding Blood Glucose Test Strips, and PRODIGY Control Solution.
If your iConnect blood glucose meter is being operated by a second person who is providing testing assistance to the user, the meter and lancing device should be disinfected prior to use by the second person. Consult your healthcare professional if unusual readings occur.
5
Image /page/5/Picture/0 description: The image shows the logo for Kbiotech. The logo consists of a stylized letter K inside of an oval shape. The word "biotech" is written in bold letters to the right of the K. Below the word "biotech" is some text in another language.
● Test Principle
Blood glucose is measured by an electrical current that is produced when a blood samples mixes with the reagent (special chemicals) of the test strip. The electrical current changes with the amount of glucose in the blood sample. The meter measures the strength of the electrical current, calculates your blood glucose level and then displays your result in either milligrams of glucose per deciliter (mg/dL) or millimoles of glucose per liter (mmol/L)
● Comparison Table
| Comparison Items | Subject device | Predicate device | Safety and
effectiveness of
subject device
compared to the
predicate device |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| MANUFACTURER | OK Biotech Co., Ltd. | Prodigy Diabetes
LLC | OK Biotech is an
associate
manufacturer
with the Prodigy |
| BRAND NAME | Prodigy | Prodigy | Same brand
name |
| MODEL NO | iConnect | Preferred® | Different
models names |
| Trade Name | PRODIGY iConnect
Blood Glucose
Monitoring System | Prodigy Preferred® Blood
Glucose
Monitoring System | Different
Trade names |
| Similarities | | | |
| Product Code | NBW, CGA | NBW, CGA | Same product
code |
| 510K NO | K142785 | K122338 | Similar
submission |
| | The PRODIGY | The Prodigy | Similar |
| | iConnect Blood | Preferred Blood | indications for |
| | Glucose Monitoring | Glucose | use |
| | System is intended to | Monitoring | |
| | be used for the | System is | |
| | quantitative | intended to be | |
| | measurement of | used for the | |
| | glucose (sugar) in | quantitative | |
| | fresh capillary whole | measurement of | |
| | blood samples drawn | glucose (sugar) in | |
| | from the fingertips, | fresh capillary | |
| | forearm, upper arm, | whole blood | |
| | palm, calf or thigh. | samples drawn | |
| | The PRODIGY | from the | |
| | iConnect Blood | fingertips, | |
| | Glucose Monitoring | forearm, upper | |
| | System is intended to | arm, palm, calf or | |
| | be used by a single | thigh. The | |
| | person and should not | Prodigy Preferred | |
| | be shared. The | Blood Glucose | |
| | PRODIGY iConnect
Blood Glucose | Monitoring
System is | |
| | Monitoring System is | intended to be | |
| | intended for | used by a single | |
| Indications for use | self-testing outside the | person and should | |
| | body (in vitro | not be shared. | |
| | diagnostic use) by | The Prodigy | |
| | people with diabetes | Preferred Blood | |
| | at home as an aid to | Glucose | |
| | monitor the | Monitoring | |
| | effectiveness of | System is | |
| | diabetes control. The | intended for | |
| | PRODIGY iConnect | self-testing | |
| | Blood Glucose | outside the body | |
| | Monitoring System | (in vitro | |
| | should not be used for | diagnostic use) | |
| | the diagnosis of or | by people with | |
| | screening of diabetes | diabetes at home | |
| | or for neonatal use. | as an aid to | |
| | Alternative site testing | monitor the | |
| | should be done only | effectiveness of | |
| | during steady - state | diabetes control. | |
| | times (when glucose is | The Prodigy | |
| | not changing rapidly). | Preferred Blood | |
| | PRODIGY No | Glucose | |
| | Coding Blood | Monitoring | |
| | Glucose Test Strips | System should | |
| | are intended for use | not be used for | |
| | with the PRODIGY
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. | 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 | Electrochemical
biosensor with carbon
electrodes | Electrochemical
biosensor with
carbon electrodes | Same principle |
| Enzyme | Glucose oxidase | Glucose oxidase | Same enzyme |
| Specimen Type | Capillary whole blood
from fingertip and
alternative sites (palm,
forearm, upper-arm,
calf and thigh) | Capillary whole
blood from
fingertip and
alternative sites
(palm, forearm,
upper-arm, calf
and thigh) | Same specimen
type |
| Test Strip | PRODIGY® No-
Coding Blood
Glucose Test Srtips | PRODIGY® No-
Coding Test | Same as previous
clearance
K122338 test |
| E-mail:service@okbiotech.com | | | |
| | | Strips | strips |
| Control solution | PRODIGY® Control
Solutions (Level 1/
Level 2) | PRODIGY®
Control Solutions
(Level 1 / Level
2) | Same as previous
clearance
K122338
control solution |
| | Sample Volume | 0.7 µL | 0.7 µL |
| Operation
Conditions' | 10 - 40 °C
(39.2 - 104 °F),
1085% R. H. | 10 - 40 °C85% R. H. | Same Operation
(39.2 - 104 °F),
10
Conditions' |
| Strip Storage
conditions | 4 - 40 °C
(39.2 - 104 °F),
1085% R. H. | 4 - 40 °C85% R. H. | Same strip
(39.2 - 104 °F),
10
storage
conditions |
| HCT Range | 20 ~ 60 % | 20 ~ 60 % | Same HCT range |
| Detecting range | 20600 mg/dL | 20600 mg/dL | Same Detecting
range |
| Power Voltage | One 3V CR2032
battery | One 3V CR2032
battery | Same battery |
| Differences | | | |
| Measuring Time | 6 seconds | 7 seconds | less measuring
time |
| Meter size | 48 mm (L) × 47 mm
(W) × 13 mm (H) | 71 mm (L) × 60
mm (W) × 19 mm
(H) | Smaller meter
size |
| | Meter Weight | Approximate 20 g
(with battery) | Approximate 45 g
(with battery) |
| Average calculation | Not applicable | 7-, 14-, 21-
and 28- days | No average
calculation |
| | 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
7
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.
8
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
● Substantial Equivalence (SE) Discussion
A claim of substantial equivalence is made to PRODIGY Preferred® Blood
9
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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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