(121 days)
Not Found
No
The description focuses on electrochemical measurement and a speaking function for accessibility, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The # Intended Use / Indications for Use states that the device is "an aid in monitoring the effectiveness of diabetes control program" and "is not intended for the diagnosis of or screening for diabetes mellitus." It measures glucose levels, which is a diagnostic and monitoring function, not a therapeutic one.
No
The document explicitly states, "It is not intended for the diagnosis of or screening for diabetes mellitus." It is intended as an aid in monitoring effectiveness, which is a management rather than a diagnostic function.
No
The device description explicitly states that the system consists of a meter and test strips, which are hardware components. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of glucose in fresh capillary whole blood." This is a measurement performed in vitro (outside the body) on a biological sample (blood).
- Device Description: The description details the use of an "electrochemical method-based meter and dry reagent biosensor (test strips)" which are components used to perform a diagnostic test on a sample.
- Aid in Monitoring: The intended use also states it's an "aid in monitoring the effectiveness of diabetes control program," which is a diagnostic purpose.
While it's not intended for the diagnosis or screening of diabetes, the act of measuring glucose in a blood sample in vitro for monitoring purposes falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Prodigy Voice Blood Glucose Monitoring System is 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. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus.
The alternative site testing in this system can be used only during steady-state blood glucose conditions.
This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.
Product codes
NBW, CGA
Device Description
Prodigy Voice Blood Glucose Monitoring System consists of a meter and 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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
finger, palm, forearm, upper-arm, calf, thigh
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self testing by persons with diabetes in the home or by healthcare professionals in healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of Prodigy Voice Blood Glucose Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the performance of this system meets its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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MAR - 5 2008
510 (k) Summary
Page 1-of-3
| Company name | DIAGNOSTIC DEVICES INC. |
|---|---|
| Contact person | Rick Admani Abulhaj |
| Address | 9300 Harris Corners Parkway |
| Suite 450, Charlotte, NC 28269 | |
| Phone | 1-704-285-6400 |
| FAX | 1-704-285-6475 |
- Name of Device Trade Names
Common Names/Descriptions
Classification Names
Prodigy Voice Blood Glucose Monitoring System Blood Glucose Meter Blood Glucose Test Strips Class II devices (21 CFR Section 862.1345, Glucose Test System)
- Predicate Device Trade/Proprietary Name: Common/Usual Name:
Submitter 510 (k) Number Prodigy Blood Glucose Test System Blood Glucose Meter Blood Glucose Test Strips DIAGNOSTIC DEVICES INC. K060467
1
4. Device Description
Prodigy Voice Blood Glucose Monitoring System consists of a meter and 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.
5. Intended Use
Prodigy Voice Blood Glucose Monitoring System is indicated for the quantitative measurement of glucose in fresh capillary whole blood taken from the finger and the alternative sites for self testing by persons with diabetes in the home or by healthcare professionals in healthcare facilities. Testing is done outside the body (in vitro diagnostic use).
The alternative site testing (the plam, the forearm, the upper arm, the calf and the thigh) in this system can be used only during steady-state blood glucose conditions.
This system contains speaker function which provides step by step instructions.
6. Comparison to Predicate Device
Prodigy Voice Blood Glucose Monitoring System has equivalent technological characteristics as the Prodigy Blood Glucose Test System (K060467). Prodigy Voice Blood Glucose Monitoring System also has the similar intended use as the Prodigy Blood Glucose Test System.
7. Performance Studies
The performance of Prodigy Voice Blood Glucose Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the performance of this system meets its intended use.
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Page 3-of-3
8. Conclusion
.
Prodigy Voice Blood Glucose Monitoring System demonstrates satisfactory performance and is suitable for its intended use.
:
:
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wing-like shapes. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Diagnostic Devices Inc. c/o Ms. Erica Li Management Representative 4F, No. 88, Sec. 1 Kwang-Fu Road San-Chung, Taipei County China (Taiwan) 241
MAR - 5 2008
Re: K073118
Trade/Device Name: Prodigy Voice Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: Class II Product Code: NBW, CGA Dated: February 13, 2008 Received: February 14, 2008
Dear Ms. Li:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Attachment A
Indications for Use
510(k) Number:
Image /page/5/Picture/3 description: The image shows a handwritten string of characters. The string appears to be a combination of letters and numbers. The characters are 'K073118'.
Device Name: Prodigy Voice Blood Glucose Monitoring System
Indications for Use:
The Prodigy Voice Blood Glucose Monitoring System is 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. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus.
The alternative site testing in this system can be used only during steady-state blood glucose conditions.
This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.
Prescription Use Over-The-Counter Use __ X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Sign-Off
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Office of In Vitro Diagnostic Device
Evaluation and Safety