(265 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies focus on standard blood glucose monitoring technology and human factors testing of labeling.
No
The device is described as a "Blood Glucose Monitoring System" intended for "quantitative measurement of glucose" and "aid to monitor the effectiveness of diabetes control," which are diagnostic/monitoring functions, not therapeutic.
No.
The "Intended Use / Indications for Use" section explicitly states: "It is not intended for the diagnosis of or diabetes".
No
The device description explicitly states that the system comprises a handheld monitor and test strips, which are hardware components. The submission also describes a human factors study related to the labeling of the physical kit carton.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states under the "Intended Use / Indications for Use" section:
- "The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use)."
This statement directly confirms its classification as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained for singertip. It is intended for single-patient home use and should not be shared. It is intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or diabetes, and it is not intended for use with neonates.
The StatStrip Xpress Blood Glucose Monitoring System comprises the StatStrip Xpress Blood Glucose Monitor and StatStrip Xpress Glucose Test Strips.
· The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use).
Product codes
NBW
Device Description
The Nova Biomedical StatStrip Xpress Blood Glucose Monitoring System consists of a hand held StatStrip Xpress Blood Glucose Monitor, StatStrip Xpress Blood Glucose Test Strips, StatStrip Xpress Blood Glucose Control Solutions (Levels 1, 2, 3, sold separately), and Instructions for Use Manual.
The modified StatStrip Xpress Blood Glucose Monitoring System is identical in fit, form, and functions to the StatStrip Xpress Blood Glucose Monitoring System, previously cleared in K160156. The Blood Glucose Monitor, Test Strip, and Control Solutions are identical. The only difference between the predicate and proposed device is the labeling:
-
- The accuracy information has been added to the modified StatStrip Xpress Blood Glucose Monitoring System kit carton label. This format is supported by the results of the newly conducted StatStrip Xpress Blood Glucose Monitoring System Human Factors Study.
-
- The Accuracy table on the original StatStrip Xpress Glucose Test Strips Insert Sheet has been replaced by the Accuracy Table suggested in the FDA guidance document "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" (October 11, 2016).
-
- The StatStrip Xpress Blood Glucose Monitoring System kit carton label has been updated with the following statement, "Proven hospital technology now available for personal use". This is supported in K160156 that the StatStrip Xpress Blood Glucose Monitoring System is equivalent to the Reference Device in K160156; StatStrip Xpress Glucose Hospital Meter System (K150461).
-
- The statement of Interferences on the StatStrip Xpress Blood Glucose Monitoring System kit carton label has been updated to "No Known interferences from common medicines like Ibuprofen, Acetaminophen, and Vitamin C".
The StatStrip Xpress Glucose Monitor is a hand-held testing device that works in conjunction with the StatStrip Glucose Test Strips. Monitor operation is self-prompting using a segmented liquid crystal display (LCD) and icons. Function and data selection is accomplished using 3 push buttons. The handheld monitor supports audible alerts and prompts with a built-in beeper. In addition to measuring glucose, the meter also stores up to 400 patient test records. The user can recall and review test results. A single coin battery powers the device, and is expected to perform up to 600 tests before needing to be replaced. A low battery prompt will appear when it is time to replace the battery. All test data is stored in a non-volatile form to prevent data loss.
The StatStrip Xpress Glucose Test Strips are designed with an electrode that measures Glucose levels. Glucose in the blood sample mixes with reagent on the test strip that produces an electric current. The amount of current that is produced depends on the amount of Glucose in the blood. The Test Strip is designed such that when a drop of blood touched the end of the strip, the blood is drawn into the reaction space via capillary action. A simple one-step process provides a blood glucose result. Test strips will be available in cartons of 100 strips (50 strips/vial). Each glucose test strip contains a reaction layer that contains glucose ● enzyme (Aspergillus sp.) >1.0 IU, mediator >20 µg, and other nonreactive substances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip (for capillary whole blood)
Indicated Patient Age Range
Not intended for use with neonates. The Human Factors study included subjects 18 years of age or older.
Intended User / Care Setting
Single-patient home use / self-testing outside the body by people with diabetes mellitus.
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
A Human Factors study of 100 Intended Use Population (Type 1 and Type 2 Layperson Diabetics) was conducted to assess the overall understanding of the accuracy information presented on the proposed outer carton label of the StatStrip Xpress Blood Glucose Monitoring System.
Inclusion Criteria:
-
- Is 18 years of age or older
-
- Is able to read and write English
-
- Has been diagnosed with Type 1 Diabetes or,
-
- Has been diagnosed with Type 2 Diabetes or,
Exclusion Criteria:
-
- Does not meet the inclusion criteria or,
-
- Has a cognitive disorder or other condition, which, in the opinion of the investigator, would seriously compromise the integrity of the study.
Subject Demographics:
Table 1: Subject Age
| Age | Number of Subjects |
|---|---|
| 25-30 | 2 |
| 31-40 | 10 |
| 41-50 | 10 |
| 51-60 | 24 |
| 61-70 | 32 |
| 71-80 | 20 |
| 81-83 | 2 |
| Total | 100 |
Table 2: Subject Gender
| Gender | Number of Subjects |
|---|---|
| Male | 37 |
| Female | 63 |
| Total | 100 |
Table 3: Subject Race
| Race | Number of Subjects |
|---|---|
| African American | 54 |
| Caucasian | 45 |
| Native American | 1 |
| Total | 100 |
Table 4: Subject Education
| Education (Total number of years) | Number of Subjects |
|---|---|
| 8 | 2 |
| 9 | 2 |
| 10 | 2 |
| 11 | 2 |
| 12 | 75 |
| 13 | 3 |
| 14 | 11 |
| ા ર | 0 |
| 16 | 3 |
| Total | 100 |
Methods and Procedures:
-
- Potential Subjects were pre-screened by the study staff for inclusion into the study using the "Inclusion/Exclusion Form" (Form I/E).
-
- The Subject completed the Informed Consent (IC) process.
-
- Each Subject was assigned a Subject number by the study staff.
-
- A study staff member gave the Subject the "Mathematics Understanding Assessment Form" (Form MUA) and asked them to answer the questions.
-
- A study staff member provided the Subject with the Kit Carton label proposal for the StatStrip Xpress Blood Glucose Monitoring System.
-
- Each Subject was then asked to completely review the Kit Carton label contents of the StatStrip Xpress Blood Glucose Monitoring System.
-
- The Subject answered each of the questions on the forms to determine their level of understanding of the StatStrip Xpress Blood Glucose Monitoring System Kit Carton labels.
-
- A study staff member provided the Subject with the Kit Carton label for the StatStrip Xpress Blood Glucose Monitoring System alongside draft Kit Carton label for the Nova Max Plus Blood Glucose Monitoring System.
-
- Each Subject was asked to completely review and compare the labeling contents.
-
- The Subject answered each of the questions to determine their ability to correctly interpret the accuracy information when comparing one meter's accuracy information to another meter's accuracy information.
-
- The Subject answered each of the questions to determine how valuable the Kit Carton accuracy labeling information presented would be to them.
Summary of Performance Studies
Study Type: Human Factors Study
Sample Size: 100 Intended Use Population (Type 1 and Type 2 Layperson Diabetics)
Key Results:
Mathematics Assessment: The average Subject score for the 10-question Mathematics Assessment was 71.3% across all races, educational levels, ages, and both genders.
Human Factors Assessment: The data collected during this Human Factors Study shows that Subjects with minimal education and who demonstrated limited mathematics skills in the mathematics assessment are able to understand the accuracy information presented on the proposed Nova StatStrip Xpress kit packaging.
Although the Subjects exhibited an average mathematical assessment score of 71.3% when performing basic mathematical percentage calculations, the Subjects exhibited a better than average (82.2% - 93.3%) ability to understand the accuracy information proposed for the device's outer kit carton.
Summary of Responses to Objective Questions:
| Topic | Form Number | Average Score (%) |
|---|---|---|
| Mathematics Assessment | MUA | 71.3 |
| Understanding Front Kit Carton | HFA 1A (Questions 1-3) | 93.3 |
| Understanding Side Kit Carton | HFA 1B | 82.2 |
| Understanding of Accuracy Comparison Information System A vs. B | HFA 2 | 86.0 |
| Understanding of Comparison Information System A vs. C | HFA 3 | 92.1 |
| Understanding Comparison Information System A vs. D | HFA 4 | 91.7 |
The Subjects answers to the subjective questions indicated that an overwhelming majority understood the importance of accuracy when choosing a glucose meter to monitor their diabetes. Furthermore, the Subjects understood the information presented to them on the proposed kit packaging, and believed that there is value in accuracy ratings when selecting a Blood Glucose Monitoring System.
Conclusion: The proposed Accuracy Summary Chart and Accuracy Grade depictions evaluated in this study are an effective way to present the performance of the Nova StatStrip Xpress Blood Glucose Monitoring System to layperson Subjects and meets the predetermined acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
November 7, 2017
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Nova Biomedical Corporation Eliza Wang Regulatory Affairs Project Manager 200 Prospect Street Waltham, Massachusetts 02454
Re: K170464
Trade/Device Name: StatStrip Xpress Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: October 4, 2017 Received: October 5, 2017
Dear Eliza Wang:
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 Part 801 and Part 809); medical device 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
1
Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. Kelm -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) K170464
Device Name
StatStrip Xpress Blood Glucose Monitoring System
Indications for Use (Describe)
The StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained for singertip. It is intended for single-patient home use and should not be shared. It is intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or diabetes, and it is not intended for use with neonates.
The StatStrip Xpress Blood Glucose Monitoring System comprises the StatStrip Xpress Blood Glucose Monitor and StatStrip Xpress Glucose Test Strips.
· The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(k) Summary for K170464
| 510(K) Owner: | Nova Biomedical Corporation |
|---|---|
| Registration Number: | 1219029 |
| Address: | 200 Prospect St. |
| Waltham, MA 02454 | |
| Phone: | 781-894-0800 |
| Fax Number: | 784-891-4806 |
| Contact Person: | Eliza Wang, RAC |
| Regulatory Affairs Project Manager | |
| Date Prepared: | November 3rd, 2017 |
| Proprietary Name: | StatStrip Xpress Blood Glucose Monitoring System |
| Common or Usual Name: | System, test, blood glucose, over the counter |
| Classification Name: | Glucose test system |
| Class Panel No. | 75 |
| Regulation Number: | 21 CFR 862.1345 |
| Product Codes: | NBW |
| Class: | II |
| Predicate Device: | StatStrip Xpress Blood Glucose Monitoring System |
| K160156 |
Device Description:
The Nova Biomedical StatStrip Xpress Blood Glucose Monitoring System consists of a hand held StatStrip Xpress Blood Glucose Monitor, StatStrip Xpress Blood Glucose Test Strips, StatStrip Xpress Blood Glucose Control Solutions (Levels 1, 2, 3, sold separately), and Instructions for Use Manual.
The modified StatStrip Xpress Blood Glucose Monitoring System is identical in fit, form, and functions to the StatStrip Xpress Blood Glucose Monitoring System, previously cleared in K160156. The Blood Glucose Monitor, Test Strip, and Control Solutions are identical. The only difference between the predicate and proposed device is the labeling:
-
- The accuracy information has been added to the modified StatStrip Xpress Blood Glucose Monitoring System kit carton label. This format is supported by the results of the newly conducted StatStrip Xpress Blood Glucose Monitoring System Human Factors Study.
4
-
- The Accuracy table on the original StatStrip Xpress Glucose Test Strips Insert Sheet has been replaced by the Accuracy Table suggested in the FDA guidance document "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" (October 11, 2016).
-
- The StatStrip Xpress Blood Glucose Monitoring System kit carton label has been updated with the following statement, "Proven hospital technology now available for personal use". This is supported in K160156 that the StatStrip Xpress Blood Glucose Monitoring System is equivalent to the Reference Device in K160156; StatStrip Xpress Glucose Hospital Meter System (K150461).
-
- The statement of Interferences on the StatStrip Xpress Blood Glucose Monitoring System kit carton label has been updated to "No Known interferences from common medicines like Ibuprofen, Acetaminophen, and Vitamin C".
Intended Use:
The StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. It is intended for single-patient home use and should not be shared. It is intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes, and it is not intended for use with neonates.
The StatStrip Xpress Blood Glucose Monitoring System comprises the StatStrip Xpress Blood Glucose Monitor, and StatStrip Xpress Glucose Test Strips. .
- . The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use).
Summary of the Technological Characteristics:
The modified StatStrip Xpress Blood Glucose Monitor System that is the subject of this submission is identical in form, fit and function, to the device cleared in K160156. The StatStrip Xpress Glucose Monitoring System is intended for in vitro diagnostic use by lay people for the quantitative determination of glucose in whole blood.
The StatStrip Xpress Glucose Monitor is a hand-held testing device that works in conjunction with the StatStrip Glucose Test Strips. Monitor operation is self-prompting using a segmented liquid crystal display (LCD) and icons. Function and data selection is accomplished using 3 push buttons. The handheld monitor supports audible alerts and prompts with a built-in beeper. In addition to measuring glucose, the meter also stores up to 400 patient test records. The user can recall and review test results.
5
A single coin battery powers the device, and is expected to perform up to 600 tests before needing to be replaced. A low battery prompt will appear when it is time to replace the battery. All test data is stored in a non-volatile form to prevent data loss.
Test Strips:
The StatStrip Xpress Glucose Test Strips of this submission are identical in form, fit, function and packaging, to the glucose test strips originally cleared in K160156. The Test Strip is designed with an electrode that measures Glucose levels. Glucose in the blood sample mixes with reagent on the test strip that produces an electric current. The amount of current that is produced depends on the amount of Glucose in the blood.
The StatStrip Xpress Glucose Test Strip reacts with the glucose in the test sample. The reaction produces an electrical current which is proportional to the amount of glucose in the sample, and the electrical current is detected by the monitor and displayed to the user as a glucose value.
The Test Strip is designed such that when a drop of blood touched the end of the strip, the blood is drawn into the reaction space via capillary action. A simple one-step process provides a blood glucose result. Test strips will be available in cartons of 100 strips (50 strips/vial).
- Contents: Each glucose test strip contains a reaction layer that contains glucose ● enzyme (Aspergillus sp.) >1.0 IU, mediator >20 µg, and other nonreactive substances.
- Function: The StatStrip Xpress Glucose Test Strips are intended for quantitative . determination of Glucose in fresh whole blood specimens. StatStrip Glucose Test Strips are for use only with the StatStrip Family of Monitors.
- . Storage Conditions: Store the Test Strips in the vial between 34-86°F (1-30°C). Ensure that the vial is closed between uses. Once opened the test strips in the vial may be used for 180 days or until the expiration date printed on the label, whichever comes first.
6
| Characteristic | Predicate Device (K160156) | Proposed Device (K170464) |
|---|---|---|
| StatStrip Xpress Blood Glucose Monitoring System | StatStrip Xpress Blood Glucose Monitoring System | |
| Intended Use | The StatStrip Xpress Blood Glucose Monitoring System is | |
| intended to be used for the quantitative measurement of | ||
| glucose in fresh capillary whole blood obtained from the | ||
| fingertip. It is intended for single-patient home use and | ||
| should not be shared. It is intended for self-testing outside | ||
| the body by people with diabetes mellitus as an aid to | ||
| monitor the effectiveness of diabetes control. It is not | ||
| intended for the diagnosis of or screening for diabetes, and | ||
| it is not intended for use with neonates. | ||
| The StatStrip Xpress Blood Glucose Monitoring System | ||
| comprises the StatStrip Xpress Blood Glucose Monitor, | ||
| StatStrip Xpress Glucose Test Strips, and StatStrip Xpress | ||
| Glucose Control Solutions. The StatStrip Xpress Glucose | ||
| Control Solutions are intended for use with the StatStrip | ||
| Xpress Blood Glucose Monitoring System as a quality | ||
| control check to verify the accuracy of blood glucose test | ||
| results. There are 3 levels of controls (Level 1, 2, and 3). | ||
| The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body ( in vitro diagnostic use). | The StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative | |
| measurement of glucose in fresh capillary whole | ||
| blood obtained from the fingertip. It is intended for | ||
| single-patient home use and should not be shared. It is | ||
| intended for self-testing outside the body by people | ||
| with diabetes mellitus as an aid to monitor the | ||
| effectiveness of diabetes control. It is not intended for | ||
| the diagnosis of or screening for diabetes, and it is not | ||
| intended for use with neonates. | ||
| The StatStrip Xpress Blood Glucose Monitoring System comprises the StatStrip Xpress Blood | ||
| Glucose Monitor and StatStrip Xpress Glucose Test | ||
| Strips. | ||
| The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body ( in vitro diagnostic use). | ||
| Characteristic | Predicate Device (K160156) | Proposed Device (K170464) |
| StatStrip Xpress Blood Glucose Monitoring System | StatStrip Xpress Blood Glucose Monitoring System | |
| Enzyme | Glucose Oxidase | Same |
| Operating Principle | Electrochemical biosensor, amperometric | Same |
| Sample type | Capillary whole blood (finger stick) | Same |
| Sample size | 1.2 μL | Same |
| Sample application | Test Strip capillary draw | Same |
| Measuring range | 20-600 mg/dL | Same |
| Hematocrit range | 20-65% | Same |
| Reported output | mg/dL | Same |
| Time Result | to ~ 6 seconds | Same |
| Quality control | 3 levels | Same |
| Handheld | Yes | Same |
| Calibration | Automatic, no calibration code | Same |
| Data storage | 400 test results | Same |
| Barcode | No | Same |
| Characteristic | Predicate Device (K160156) | Proposed Device (K170464) |
| StatStrip Xpress Blood Glucose Monitoring System | StatStrip Xpress Blood Glucose Monitoring System | |
| Power source | 3v DC Li coin cell battery | Same |
| Dimensions | 3.6x2.3x0.9 in (91.4x58.4x22.9 mm) | Same |
| Weight | 2.65 ounces (75grams) | Same |
Table 1: Comparison of Predicate and Proposed devices
7
8
9
Summary of Testing:
Human Factors Study
A Human Factors study of 100 Intended Use Population (Type 1 and Type 2 Layperson Diabetics) was conducted to assess the overall understanding of the accuracy information presented on the proposed outer carton label of the StatStrip Xpress Blood Glucose Monitoring System.
Inclusion Criteria:
-
- Is 18 years of age or older
-
- Is able to read and write English
-
- Has been diagnosed with Type 1 Diabetes or,
-
- Has been diagnosed with Type 2 Diabetes or,
Exclusion Criteria:
-
- Does not meet the inclusion criteria or,
-
- Has a cognitive disorder or other condition, which, in the opinion of the investigator, would seriously compromise the integrity of the study.
Subject Demographics:
Table 1: Subject Age
| Age | Number of Subjects |
|---|---|
| 25-30 | 2 |
| 31-40 | 10 |
| 41-50 | 10 |
| 51-60 | 24 |
| 61-70 | 32 |
| 71-80 | 20 |
| 81-83 | 2 |
| Total | 100 |
Table 2: Subject Gender
| Gender | Number of Subjects |
|---|---|
| Male | 37 |
| Female | 63 |
| Total | 100 |
10
Table 3: Subject Race
| Race | Number of Subjects |
|---|---|
| African American | 54 |
| Caucasian | 45 |
| Native American | 1 |
| Total | 100 |
Table 4: Subject Education
| Education (Total number of years) | Number of Subjects |
|---|---|
| 8 | 2 |
| 9 | 2 |
| 10 | 2 |
| 11 | 2 |
| 12 | 75 |
| 13 | 3 |
| 14 | 11 |
| ા ર | 0 |
| 16 | 3 |
| Total | 100 |
Methods and Procedures:
-
- Potential Subjects were pre-screened by the study staff for inclusion into the study using the "Inclusion/Exclusion Form" (Form I/E).
-
- The Subject completed the Informed Consent (IC) process.
-
- Each Subject was assigned a Subject number by the study staff.
-
- A study staff member gave the Subject the "Mathematics Understanding Assessment Form" (Form MUA) and asked them to answer the questions.
-
- A study staff member provided the Subject with the Kit Carton label proposal for the StatStrip Xpress Blood Glucose Monitoring System.
-
- Each Subject was then asked to completely review the Kit Carton label contents of the StatStrip Xpress Blood Glucose Monitoring System.
-
- The Subject answered each of the questions on the forms to determine their level of understanding of the StatStrip Xpress Blood Glucose Monitoring System Kit Carton labels.
-
- A study staff member provided the Subject with the Kit Carton label for the StatStrip Xpress Blood Glucose Monitoring System alongside draft Kit Carton label for the Nova Max Plus Blood Glucose Monitoring System.
-
- Each Subject was asked to completely review and compare the labeling contents.
11
-
- The Subject answered each of the questions to determine their ability to correctly interpret the accuracy information when comparing one meter's accuracy information to another meter's accuracy information.
-
- The Subject answered each of the questions to determine how valuable the Kit Carton accuracy labeling information presented would be to them.
Study Findings:
Mathematics Assessment:
The average Subject score for the 10-question Mathematics Assessment was 71.3% across all races, educational levels, ages, and both genders.
Human Factors Assessment:
The data collected during this Human Factors Study shows that Subjects with minimal education and who demonstrated limited mathematics skills in the mathematics assessment are able to understand the accuracy information presented on the proposed Nova StatStrip Xpress kit packaging.
Although the Subjects exhibited an average mathematical assessment score of 71.3% when performing basic mathematical percentage calculations, the Subjects exhibited a better than average (82.2% - 93.3%) ability to understand the accuracy information proposed for the device's outer kit carton.
| Topic | Form Number | Average Score (%) |
|---|---|---|
| Mathematics Assessment | MUA | 71.3 |
| Understanding Front Kit Carton | HFA 1A (Questions 1-3) | 93.3 |
| Understanding Side Kit Carton | HFA 1B | 82.2 |
| Understanding of Accuracy Comparison Information System A vs. B | HFA 2 | 86.0 |
| Understanding of Comparison Information System A vs. C | HFA 3 | 92.1 |
| Understanding Comparison Information System A vs. D | HFA 4 | 91.7 |
Table 5: Summary of Responses to Objective Questions
12
The Subjects answers to the subjective questions indicated that an overwhelming majority understood the importance of accuracy when choosing a glucose meter to monitor their diabetes.
Furthermore, the Subjects understood the information presented to them on the proposed kit packaging, and believed that there is value in accuracy ratings when selecting a Blood Glucose Monitoring System.
Conclusion:
The proposed Accuracy Summary Chart and Accuracy Grade depictions evaluated in this study are an effective way to present the performance of the Nova StatStrip Xpress Blood Glucose Monitoring System to layperson Subjects and meets the predetermined acceptance criteria.