(313 days)
Not Found
No
The summary describes a standard electrochemical blood glucose monitoring system and does not mention any AI or ML capabilities. The performance studies focus on traditional analytical and clinical validation metrics.
No
Explanation: The device is a blood glucose monitoring system, intended for measurement and monitoring, not for therapeutic intervention or treatment. It is explicitly stated as being for "in vitro diagnostic use."
No.
The "Intended Use / Indications for Use" states that the device "should not be used for the diagnosis of, or screening for diabetes".
No
The device description explicitly states that the system consists of a meter and test strips, which are hardware components. The summary also details performance studies related to the meter and test strips, further indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section for both the Prodigy® Astro Blood Glucose Monitoring System and the Prodigy® Astro PRO Blood Glucose Monitoring System explicitly states: "The Prodigy® Astro Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use)..." and "The Prodigy® Astro PRO Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use)...".
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. This device measures glucose in blood samples taken from the body.
- Purpose: The intended use is to "monitor the effectiveness of diabetes control," which is a diagnostic purpose performed on a sample outside the body.
Therefore, based on the provided text, the Prodigy® Astro Blood Glucose Monitoring System and the Prodigy® Astro PRO Blood Glucose Monitoring System are clearly identified as in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
Prodigy Astro 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® Astro Blood Glucose Monitoring System is intended to be used in the home by a single person and should not be shared. The Prodigy® Astro 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® Astro Blood Glucose Monitoring System should not be used for the diagnosis of, or screeming 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 Astro blood glucose meters to measure 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.
Prodigy® Astro PRO 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® Astro PRO Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use by healthcare professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The Prodigy® Astro PRO 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 PRO No Coding Test Strips are intended for use with the PRODIGY Astro PRO blood glucose meters to measure concentration of blood glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The system should only be used with single-use, auto-disabling lancing devices.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA
Device Description
The Prodigy Astro Blood Glucose Monitoring System and the Prodigy Astro PRO Blood Glucose Monitoring System are identical devices (hereafter both are called the System), but the latter is claimed to be used not only in the home by a single person but also in professional healthcare settings.
The System consists of a meter and Prodigy No Coding Test Strips (or Prodigy PRO 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 System is marketed as a meter only with a carrying case, batteries, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card. The 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, Glucose Oxidase, derived from Aspergillus niger.
Test Principle
Electrochemical biosensor with carbon electrodes that is referring to detection of glucose by the test strips. The 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh
Indicated Patient Age Range
Not Found
Intended User / Care Setting
PRODIGY Astro Blood Glucose Monitoring System: in the home by a single person, for self-testing.
PRODIGY Astro PRO Blood Glucose Monitoring System: multiple-patient use by healthcare professionals in professional healthcare settings.
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)
Non-Clinical Performance Characteristics:
- Software verification and validation testing (IEC 62304:2006, FDA Guidance, 5/2005): All software documentation was prepared and submitted in accordance with FDA guidance documents. Software was tested against established Software Design Specifications, performing as intended. Device Hazard Analysis was completed and risk control implemented. Testing results confirm all software specifications met acceptance criteria.
- 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): The Systems met all relevant sections (Radiated Emissions, Electrostatic Discharge Immunity Test, Radiated Radio-Frequency Electromagnetic Immunity, and Power Frequency Magnetic Field Immunity Test) of the listed standards.
- 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): The Systems comply with applicable voluntary standards for Electrical Safety and passed all electrical safety testing.
- Robustness Evaluation (FDA Guidance, Jan/2014): Study results using PDI SUPER SANI-CLOTH germicidal disposable wipes indicated no deterioration of components after cleaning and disinfection. The devices operated correctly. Validated cleaning and disinfection cycles were 520 for Prodigy Astro BGMS and 10950 for Prodigy Astro Pro BGMS. Individual bias of meter measurements vs. YSI mean were 0.95. 100 % of bias (or bias %) of individual glucose results fell within ±10 % or 10%. Test results met acceptance criteria.
- System Accuracy Evaluation (FDA Guidance 02/28/1997): Evaluated against YSI as reference standard. > 95% of test results fell within ±15 mg/dL at glucose
§ 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 stylized caduceus symbol, which features three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 20, 2016
OK BIOTECH CO., LTD. DR. JEN, KE-MIN OFFICIAL CORRESPONDENT NO. 91, SEC. 2, GONGDAO 5TH ROAD HSINCHU CITY 30070, TAIWAN
Re: K152599
Trade/Device Name: PRODIGY Astro Blood Glucose Monitoring System. PRODIGY Astro PRO Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: July 1, 2016 Received: July 08, 2016
Dear Dr. 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 (OS) 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/ResourcesforYou/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) K152599
Device Name
PRODIGY Astro Blood Glucose Monitoring System
Indications for Use (Describe)
Prodigy® Astro 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 Prodig® Astro Blood Glucose Monitoring System is intended to be used in the home by a single person and should not be shared. The Prodigy® Astro 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® Astro Blood Glucose Monitoring System should not be used for the diagnosis of, or screeming 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 Astro blood glucose meters to measure 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.
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."
3
Indications for Use
510(k) Number (if known) K152599
Device Name
PRODIGY Astro PRO Blood Glucose Monitoring System
Indications for Use (Describe)
Prodigy® Astro PRO 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® Astro PRO Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use by healthcare professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The Prodigy® Astro PRO 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 PRO No Coding Test Strips are intended for use with the PRODIGY Astro PRO blood glucose meters to measure concentration of blood glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The system should only be used with single-use, auto-disabling lancing devices.
Type of Use (Select one or both, as applicable)
2 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."
4
Image /page/4/Picture/0 description: The image shows a logo for "Kbiotech". The logo consists of 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. The logo appears to be for a technology or biotechnology company.
Taiwan : TEL : 886-3-5160258 FAX : 886-3-5160028 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 | Traditional |
|---|---|
| Basis for the submission | A New Device |
| Common Name Of The Proposed Device | Blood Glucose Monitoring System |
| Trade name | PRODIGY Astro Blood Glucose Monitoring |
| System | |
| PRODIGY Astro PRO 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 | July 1, 2016 |
| Official Correspondent | 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 | CGA, NBW |
| Predicate Device | PRODIGY AutoCode Eject Blood Glucose |
| Monitoring System (K141914) |
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Image /page/5/Picture/0 description: The image shows a logo with the letter K inside of a circle. To the right of the logo is the word "biotech" in a stylized font. Below the logo and the word is a line of text in a different language.
Intended Use: ●
Prodigv Astro Blood Glucose Monitoring System
Prodigy Astro 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 Astro Blood Glucose Monitoring System is intended to be used in the home by a single person and should not be shared. The Prodigy® Astro 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® Astro 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 Astro blood glucose meters to measure 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.
Prodigy Astro PRO Blood Glucose Monitoring System
Prodigy® Astro PRO 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 Astro PRO Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use by healthcare professionals in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The Prodigy Astro PRO 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 PRO No Coding Test Strips are intended for use with the PRODIGY Astro PRO blood glucose meters to measure concentration of blood glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The system should only be used with single-use, auto-disabling lancing devices.
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Image /page/6/Picture/0 description: The image shows a logo with the letters 'K' and 'biotech' in a stylized font. The 'K' is surrounded by an orbital design. Below the word 'biotech' is a line of text in a different language, possibly Chinese. The logo appears to represent a company or organization in the biotechnology field.
Device Description:
The Prodigy Astro Blood Glucose Monitoring System and the Prodigy Astro PRO Blood Glucose Monitoring System are identical devices (hereafter both are called the System), but the latter is claimed to be used not only in the home by a single person but also in professional healthcare settings.
The System consists of a meter and Prodigy No Coding Test Strips (or Prodigy PRO 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 System is marketed as a meter only with a carrying case, batteries, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card. The 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, Glucose Oxidase, derived from Aspergillus niger.
● Test Principle
Electrochemical biosensor with carbon electrodes that is referring to detection of glucose by the test strips. The 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.
7
Image /page/7/Picture/0 description: The image shows a logo with the letter K in a stylized font. Next to the K is the word "biotech" in a smaller font. Below the logo is some text in a different language, possibly Chinese. The logo appears to be for a company or organization related to biotechnology.
Comparison Table ●
| Comparison Items | Predicate device | Subject device |
|---|---|---|
| MANUFACTURER | OK Biotech Co., Ltd. | OK Biotech Co., Ltd. |
| BRAND NAME | Prodigy | Prodigy |
| Model Number | AutoCode Eject | Astro |
| Trade Name | Prodigy® AutoCode EjectTM | |
| Blood Glucose Monitoring System | *Prodigy® AstroTM Blood | |
| Glucose Monitoring System | ||
| *Prodigy® AstroTM PRO Blood | ||
| Glucose Monitoring System | ||
| Product Code | CGA, NBW | CGA, NBW |
| 510(k) No. | K141914 | K152599 |
| Similarities | ||
| Test Principle | Electrochemical biosensor with | |
| carbon electrodes that is | ||
| referring to detection of glucose | ||
| by the test strips. The 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. | Same principle | |
| Enzyme | Glucose oxidase | Same Enzyme |
| Specimen Type | Capillary whole blood from | |
| fingertip and alternative sites | ||
| (palm, forearm, upper-arm, calf | ||
| and thigh) | Same specimen type | |
| Test Strip | PRODIGY® No Coding Test | |
| Strips | *PRODIGY No Coding Test Strips | |
| *PRODIGY PRO No Coding Test | ||
| Strips | ||
| Control solution | PRODIGY® Control Solution | |
| (Level 1 & Level 2) | Same control solution as K141914 | |
| Sample Volume | 0.7 µL | Same sample volume |
| Operating Conditions | 50 °F - 104 °F | |
| 10~85% RH. (non-condensing) | Same Operating Conditions | |
| Strip Storage | ||
| Conditions | 39 °F - 104 °F | |
| 10~85% R.H. (non-condensing) | Same Strip Storage Conditions | |
| HCT Range | 20 ~ 60 % | Same HCT range |
| Detecting range | 20~600 mg/dL | Same detecting range |
| Temperature | ||
| compensation | ||
| mechanism | Automatic compensation with | |
| built-in thermistor | Same mechanism | |
| Measuring Time | 6 seconds | Same measuring time |
| Memory Storage | 450 tests | Same memory storage |
| Power Battery | 1.5V AAA Alkaline battery x2 | Same power batteries |
| Differences | ||
| 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 | *Indications for use of the Prodigy | |
| Astro Blood Glucose Monitoring | ||
| System are the same as the | ||
| predicate device except for the | ||
| speaking function. |
*The IFU of Prodigy Astro PRO
Blood Glucose Monitoring System
is almost the same as the predicate
device, and the major difference is
that it is intended to be used in
professional healthcare settings and
has no speaking function. |
| | | |
| | 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 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. | |
| Meter size | 100 mm (L) × 56 mm (W) × 23 | 108.5 mm (L) × 62.5 mm (W) × 30 |
| | mm (H) | mm (H) |
| Meter Weight | Approximate 79 g | Approximate 105 g |
| | (with batteries) | (with batteries) |
| Speaking feature | Yes | No |
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Image /page/8/Picture/0 description: The image contains a logo for "Kbiotech". The logo features a stylized letter "K" enclosed in a circular shape, with the word "biotech" written in bold, slightly italicized letters next to it. Below the word "biotech", there are some Chinese characters.
E-mail:service@okbiotech.com
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Image /page/9/Picture/0 description: The image shows a logo for a company called "Kbíotech". The logo consists of a stylized letter "K" with a circle around it, followed by the word "bíotech" in a bold, sans-serif font. Below the company name is some text in Chinese characters. The logo is simple and modern, and the use of black and white gives it a clean and professional look.
● Substantial Equivalence (SE) Discussion
A claim of substantial equivalence is made to PRODIGY AutoCode Eject Blood Glucose Monitoring System (K141914). Both of them have the same working principle and technologies, including using the same Prodigy No-Coding Test Strips (or Prodigy PRO No Coding Test Strips).and PRODIGY Control Solution.
The major differences for the two devices are intended use, meter dimensions, meter weight, speaking feature. The speaking function for the predicate device is indicated not to be used by visually impaired person, just an aid for all of the users. The subject device, Prodigy Astro BGMS, is indicated for use in the home by a single-person and should not be shared, and Prodigy Astro PRO GMS in professional healthcare settings. The predicate device is intended for use only in the home by a single-person. The subject device thus differentiates the users by providing two separate sets of Owner's Manuals, product labels and Boxes labels. The other differences, meter weight and size, are due to the feature design aspects, not related to the safety and effectiveness concerns.
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Image /page/10/Picture/0 description: The image contains a logo for "Kbiotech". The logo features a stylized letter "K" enclosed in a circular design, followed by the word "biotech" in a bold, italicized font. Below the word "biotech", there is some text in a different language, possibly Chinese or Japanese, which appears to be the company's name or a related description.
● Summary of the Non-Clinical Performance Characteristics
The following non-clinical testing was conducted on the PRODIGY Astro Blood Glucose Monitoring System (BGMS) 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, NCCLS EP5-A2)
- Linearity Evaluation (NCCLS/CLSI, EP6-A, FDA Guidance 02/28/1997,
- System Accuracy Evaluation ( FDA Guidance 02/28/1997)
- Hematocrit Evaluation (FDA Guidance 02/28/1997)
- Interference Study (FDA Guidance 02/28/1997, CLSI EP7-A2)
- Operation Condition Study (EN 13640)
- Sample Volume Study
- Virucide Evaluation for Case & Lens materials (CLSI EP17-A)
- Altitude Study (FDA Guidance 02/28/1997)
- Mechanical Resistance Study ( IEC 60068-2-64:1993, IEC 61010-1:2010)
- Shelf Life Study of Test Strips
- Shelf Life Study of the Meters
Testing demonstrated the PRODIGY Astro (or Astro PRO) BGMS (abbreviated as the Systems) meets all relevant standards requirements. Internal verification and validation testing confirm that the product specifications are met which are equivalent in design and technological characteristics to the predicate device. Testing of the Systems supports the claims of substantial equivalence to the predicate device.
Software validation: 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.
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E-mail:service@okbiotech.com
Electrical safety: The Systems complies with the applicable voluntary standards for the Electrical Safety. The device 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 Systems have 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, I 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.
Robustness Study: The Systems are intended for single-patient use or for use in professional healthcare settings. According to the study results with the use of PDI SUPER SANI-CLOTH germicidal disposable wipes (EPA Reg. No. 9480-4), the deterioration of all of the components of the devices did not occur and the devices were operated correctly after cleaning and disinfection treatments. The number of cleaning and disinfection cycles validated for the Prodigy Astro BGMS and for the Prodigy Astro Pro BGMS are 520 and 10950 cycles respectively. The individual bias of the meter measurements compared with individual YSI mean were less than 10 mg/dL at glucose concentrations