PREFERRED BLOOD GLUCOSE MONITORING SYSTEM
Device Facts
| Record ID | K122338 |
|---|---|
| Device Name | PREFERRED BLOOD GLUCOSE MONITORING SYSTEM |
| Applicant | Prodigy Diabetes Care, LLC |
| Product Code | NBW · Clinical Chemistry |
| Decision Date | Nov 5, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
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 or thigh. The Prodigy Preferred Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Prodigy Preferred 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 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). The Prodigy No Coding Test Strips are for use with the Prodigy Preferred Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh.
Device Story
System comprises handheld meter and dry reagent biosensor test strips (glucose oxidase). User applies fresh capillary whole blood sample (min 0.7 µL) to test strip; meter performs electrochemical measurement (amperometry). Current magnitude is proportional to glucose concentration. Device features automatic temperature compensation via thermistor. Results displayed on LCD; stored in internal memory (120 measurements). Data exportable via RS232 port. Used by patients at home for self-monitoring. Healthcare providers use output to assess diabetes control effectiveness. System includes cleaning/disinfection protocols for single-patient use.
Clinical Evidence
Clinical performance evaluated via lay user study (n=150) and healthcare professional study (n=100). Accuracy compared against YSI 2300 reference method across multiple body sites (finger, palm, forearm, upper arm, calf, thigh). Results met ISO 15197:2003 criteria: 95% of results <75 mg/dL within ±15 mg/dL and ≥75 mg/dL within ±20% of reference. Bench testing confirmed linearity (20-600 mg/dL), precision (CV 2.5-5.5%), and lack of interference from 24 common substances.
Technological Characteristics
Electrochemical biosensor; glucose oxidase enzyme; amperometric sensing; automatic temperature compensation via thermistor; 0.7 µL sample volume; 7-second reaction time; 20-600 mg/dL range; RS232 connectivity; battery-powered; LCD display; 90-day strip vial stability; 20-60% hematocrit range.
Indications for Use
Indicated for quantitative blood glucose measurement in people with diabetes mellitus for home monitoring of diabetes control. Suitable for capillary whole blood from fingertips, forearm, palm, calf, or thigh. Contraindicated for neonatal use, diabetes diagnosis, or screening. Alternative site testing restricted to steady-state glucose conditions.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Prodigy Voice Blood Glucose Monitoring System (k073118)
Submission Summary (Full Text)
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# 510(k) Summary 807.92(c)
# SPONSOR
Prodigy Diabetes LLC
Company Address:
Company Name:
2701-A Hutchison McDonald Road Charlotte, NC 28269
Telephone: Fax: Contact Person: 704-285-6400 704-285-6475 Rick Admani
**NOV 05 2013**
Summary Preparation Date: November 4, 2013
| DEVICE NAME | 807.92(a)(2) |
|----------------------|----------------------------------------------------|
| Trade Name: | Prodigy® Preferred Blood Glucose Monitoring System |
| Common/Usual Name: | Blood Glucose Meter |
| Classification Name: | System, Test, Blood Glucose, Over the Counter |
| Regulation Number: | 862.1345 |
| Product Code: | NBW, CGA |
| Device Class: | II |
| Panel: | Clinical Chemistry |
### PREDICATE DEVICE
### 807.92(a)(3)
807.92(a)(4)
807.92(a)(1)
| Legally Marketed Equivalent Device | | |
|------------------------------------|--------------------|----------|
| Company | Product | 510(k) # |
| Diagnostic Devices, Inc. | Prodigy Voice BGMS | K073118 |
### DEVICE DESCRIPTION
The Prodigy Preferred 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 Preferred Blood Glucose Monitoring System is marketed as a meter only with a carrying case, battery, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card. The Prodigy Preferred Blood Glucose Monitoring System is also marketed as a meter kit with a carrying case, battery, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card,
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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.
#### DEVICE INTENDED USE
#### 807.92(a)(5)
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 or thigh. The Prodigy Preferred Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Prodigy Preferred 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 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).
The Prodigy No Coding Test Strips are for use with the Prodigy Preferred Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh.
| Item | Subject device | Predicate Device |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Prodigy Preferred BGMS | Prodigy Voice BGMS |
| Manufacturer | Prodigy Diabetes Care, LLC | Diagnostic Devices, Inc. |
| K Number | | K073118 |
| Similarities | | |
| Indications for<br>Use | The Prodigy Preferred Blood Glucose<br>Monitoring System is intended to be<br>used for the quantitative<br>measurement of glucose (sugar) in<br>fresh capillary whole blood samples<br>drawn from the fingertips, forearm,<br>upper arm, palm, calf or thigh. The<br>Prodigy Preferred Blood Glucose<br>Monitoring System is intended to be<br>used by a single person and should<br>not be shared.<br><br>The Prodigy Preferred Blood Glucose<br>Monitoring System is intended for<br>self testing outside the body (in vitro) | The Prodigy Voice Blood Glucose<br>Monitoring System is intended for use in<br>the quantitative measurement of<br>glucose in fresh capillary whole blood<br>from the finger and the following<br>alternative sites: the palm, the forearm,<br>the upper-arm, the calf and the thigh. It<br>is intended for use by healthcare<br>professionals and people with diabetes<br>mellitus at home as an aid in monitoring<br>the effectiveness of diabetes control<br>program. It is not intended for the<br>diagnosis of or screening for diabetes<br>mellitus.<br><br>The alternative site testing in this |
| | | |
| | diagnostic use) by people with<br>diabetes at home as an aid to<br>monitor the effectiveness of diabetes<br>control. The Prodigy Preferred Blood<br>Glucose Monitoring System should<br>not be used for the diagnosis of or<br>screening of diabetes or for neonatal<br>use. Alternative site testing should<br>be done only during steady - state<br>times (when glucose is not changing<br>rapidly).<br><br>The Prodigy No Coding Test Strips<br>are for use with the Prodigy<br>Preferred Blood Glucose Meter to<br>quantitatively measure glucose<br>(sugar) in fresh capillary whole blood<br>samples drawn from the fingertips,<br>forearm, upper arm, palm, calf or<br>thigh. | system can be used only during<br>steady-state blood glucose<br>conditions. |
| Detection<br>method | Amperometry: measuring a current<br>produced by a chemical reaction | Amperometry: measuring a current<br>produced by a chemical reaction |
| Enzyme | Glucose oxidase | Glucose oxidase |
| Test strip<br>calibration | Code number checking | Code number checking |
| Temperature<br>compensation | Automatic compensation with built-<br>in thermister | Automatic compensation with built-<br>in thermister |
| Sample volume<br>(µL) | 0.7 µL | 0.7 µL |
| Reaction time<br>(sec) | 7 | 7 |
| Measurement<br>range | 20-600 mg/dL | 20-600 mg/dL |
| Operating<br>condition | 50° F - 104°F (10°C- 40°C), below<br>85% R.H. (noncondensing) | 50° F - 104°F (10°C- 40°C), between<br>10% and 85% R.H. (noncondensing) |
| Strip vial<br>opened use<br>time | 90 days | 90 days |
| Auto shut off<br>(min) | 3 | 3 |
| Alarm | Beeping sound and/or error message<br>in LCD display | Beeping sound and/or error message<br>in LCD display |
| Communication | RS232 port | RS232 port |
| Differences | | |
| Memory<br>feature | 120 measurements with day and<br>time | 450 measurement with day and time |
| Day average | 7-, 14-, 21-, 28- average glucose<br>result | 7-, 14-, 21-, 28-, 60- and 90 day<br>average glucose result |
| Speaking<br>function | no | yes |
| Weight | 2.81 in. (L) x 2.375 in. (W) x 0.75 in.<br>(H)<br>71mm (L) x 60mm (W) x 19mm (H) | 3.78 in. (L) x 1.7 in. (W) x 0.71 in. (H)<br>95mm (L) x 55mm (W) x 18mm (H) |
| Dimension | 1.6 oz with battery | 2.4 ozs |
| | 45 g | 68 g |
| Appearance | Picture / illustration of device | Picture / illustration of device |
### Predicate Product Comparison Chart
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.
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COMPARISON OF TECHNICAL CHARACTERISTICS
807.92(a)(6)
Prodigy Preferred Blood Glucose Monitoring System has equivalent technological characteristics and intended use as the Prodigy Voice Blood Glucose Monitoring System (K073118). The Preferred Blood Glucose Monitoring System does not have the Voice capability.
### PERFORMANCE TESTING
807.92(b)
### Precision test
According to the test results, the pooled and maximum SD were less than 5.0mg/dL at glucose concentration <75mg/dL, and pooled and maximum CV were less than 5.0% at glucose concentration ≥75mg/dL. The maximum individual bias was less than 10% compared with glucose analyzer YSI2300. The test results met the acceptance criteria.
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#### Linearity
According to our test results, the correlation coefficient is greater than 0.95. That is, our test results and YSI 2300 were highly correlated. The linearity of our measurement is acceptable between 20 to 600 mg/dL. 100 % of the bias of individual glucose results fallen within ±10 %. The test results met the acceptance criteria.
#### System Accuracy
According to the test results, more than 95% test results of all alternative site tested fall within the acceptance criteria (15mg/dL for blood glucose level <75 mg/dL and 20% for blood glucose level ≥75mg/dL). The system accuracy of finger and AST of Prodigy Preferred Blood Glucose Monitoring System met the requirement of ISO 15197.
#### Interference
The Prodigy Preferred® Blood Glucose Monitoring System was tested for interfering substances. All the bias of test results were ~ 10% compared with the measurements of the controlled pool. No obvious interference was observed in the interfering substance at therapeutic or physiological levels at three blood glucose levels. Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately.
Elevated blood triglyceride, Reducing substances such as uric acid and ascorbic acid, Acetaminophen, Dopa, Methyldopa, L-dopa, and Tolbutamide (when occurring in normal blood or normal therapeutic concentrations) do not significantly affect results. However, abnormally high concentrations in blood may cause inaccurately high results.
#### Hematocrit
According to the data, when blood sample with HCT between 20% to 60%, all of the individual difference of the tests compared with individual YSI mean were less than ±10%. All of the individual bias of the tests compared with YSI mean in HCT 40% was less than ±10%. All SD were <5mg/dL and all CV were <5%. The test result supported an acceptance HCT range for Prodigy Preferred Blood Glucose Monitoring System was 20% to 60%.
#### Volume Verification Study
Based on the data, the sample volumes between 0.7to 1 .5µL were fall within acceptable criteria. In order to obtain more accurate results, testing blood glucose value with the Prodigy Preferred Blood Glucose Monitoring System required at least0.7uL of blood
Measurement Internal Determination Test
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The glucose measurements with the check strip before and after high temperature exposure is less than 0.2 mg/dl. The mean difference of the before and after test strip measurements using the control solutions Level N and Level H is less than 3.6 mg/dl for each. The test results exceed the acceptance criteria of 2.0 mg/dL difference for the before and after exposure check strip measurements and 5.0 mg/dL mean difference for the before and after control solution measurements. The meters pass this performance test.
#### Altitude Study
lt shows the individual results fall within ± 10 % at the altitude from 91 to 3,402 meters. The results meet the acceptance criteria. So it shows no significant effects on Prodigy Preferred Blood Glucose Monitoring System at various altitudes from 298 feet to 11,161 feet (91 to 3,402 meters).
#### Storage Condition for Prodigy No Coding Test Strips
According to the test results, all the individual bias was less than ± 10 %. The results show all the unused test strips were stable in a period of 24months and 90 days in used vials even after transportation.
Temperature for Equipment
The maximum individual bias of the meters treated to extreme temperature measurements compared with the YSI 2300 were <10% by using venous whole blood. The test results met the acceptance criteria.
#### Humidity test for Equipment
The maximum individual bias of the meters treated to extreme humidity measurements compared with the YSI 2300were <10% by using venous whole blood. The test results met the acceptance criteria.
Operating Condition for Prodigy No Coding Test Strips According to the test results, the performance of individual bias of the test strips evaluated in the extreme environments was less than ± 10 %, the result meets the acceptance criteria.
#### Low Temperature Test
The glucose measurements with the check strip before and after low temperature exposure are less than 0.2 mg/dl. The mean difference of the before and after test strip measurements using the control solutions Level Normal and Level High are less than 3.9 mg/dl for each. The test results exceed the acceptance criteria of 2.0 mg/dL difference for the before and after exposure
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check strip measurements and 5.0 mg/dL difference for the before and after control solution measurements. The meters pass this performance test.
#### Humidity Detection Limit
It shows that all CV of the test results are less than 4 %, that the data is accepted. The total CV of the average values at different humidity levels are less than 4 % for "Normal" and "High" control solution for the humidity range from RH 10 ~ 85%.
#### High Temperature Test
The glucose measurements with the check strip before and after high temperature exposure is less than 0.2 mg/dl. The mean difference of the before and after test strip measurements using the control solutions Level N and Level H is less than 3.6 mg/dl for each.
The test results exceed the acceptance criteria of 2.0 mg/dL difference for the before and after exposure check strip measurements and 5.0 mg/dL mean difference for the before and after control solution measurements. The meters pass this performance test.
#### Temperature Test
It shows that all precisions of the test results are less than 4 %, so that the data is accepted. The total CV of the average values at different temperatures are less than 4 % for "Normal" and "High" Prodigy control solution for the temperature range from 10 to 40°C.They are passed the temperature with the Operating temperature (10~40℃) and Storage temperature (4~40℃), Robustness Test
According to the test results, the appearance, structure and function of the meters were quite regular after cleaning and disinfection cycles including 5,000 times for single-patient use claim, and the lancing devices were the same as the testing meters after 156 times cleaning and disinfection cycles. 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 < 75 mg/dL and less than ± 10 % at glucose concentrations ≥75 mg/dL. The test results met acceptance criteria.
#### Disinfection Efficacy Validation Study
In order to evaluate the efficacy of disinfection procedure with specified disinfectant that is DISPATCH®Hospital Cleaner Disinfection Towel with Bleach, coupons from the four test articles, Blood Glucose Meter were tested in this study. Our assay followed the guidance of FDA and carried out in a strict manner for safety considerations. The result revealed that HBV of clinical sera could be efficaciously removed from the Blood Glucose Meter provided by OKBiotech CO.,
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. Ltd after completing the designed disinfection procedure. The study demonstrates the disinfection procedure and virucidal would be a robust method to protect the users to avoid HBV infection.
Software Validation
The Software of Prodigy Preferred Blood Glucose Meter meets the requirements of FDA's guidance document "Guidance for the Content of Pre-market Submission for Software Contained in Medical Devices".
Human Factor Study
Ease of Use = 98.5% Label Comprehension = 99.5%
Electrical Testing
EN 61236-1 EMC Test = Passed EN 60601-1-2 EMC Test = Passed
FCC CFR 47 18 Subpart C = Passed
Design verification and validation testing confirmed that the performance, safety, and effectiveness of the Prodigy Preferred Blood Glucose Monitoring System was equivalent to that of the predicate device.
#### Conclusion
The Prodigy Preferred Blood Glucose monitoring System is substantially equivalent in its intended use, performance, safety, effectiveness and the underlying scientific and operating principles used, to the predicate Prodigy Voice Blood Glucose Monitoring System (K073118).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. 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 symbol that resembles an abstract representation of a human figure or a flame.
Public I leulth Service
Food and Drug Administration 10903 New Humpshire Avenue Document Control Center - WO66-6168 Silver Spring, MD 20993-0002
November 5, 2013
PRODIGY DIABETES CARE, LLC C/O E.J. SMITH, CONSULTANT SMITH ASSOCIATES 1468 HARWELL AVENUE CROFTON MD 21114
Re: K122338
Trade/Device Name: Preferred Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: October 28, 2013 Received: October 29, 2013
Dear E.J. Smith:
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 r ou may , more or ovisions of the Act include requirements for annual registration, listing of general controls provisions or ractice, 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.
1f 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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Page 2-E.J. Smith
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
# Carol C. Benson -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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K122338
#### Device Name
Prodigy Preferred Blood Glucose Monitoring System
Indications for Use (Describe)
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, palm, calf or thigh. The Prodigy Preferred Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Prodigy Preferred Blood Glucose Monitoring System is intended for self testing outside the body (in virro 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. Allemative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The Prodigy No Coding Test Strips are for use with the Prodigy Preferred Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh.
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)
