(138 days)
Not Found
No
The description of the Bolus Advisor indicates it uses pre-programmed parameters (target blood glucose, insulin-to-carbohydrate ratio, insulin sensitivity) provided by a healthcare professional to calculate insulin doses. This suggests a rule-based or algorithmic approach rather than AI/ML which typically involves learning from data. The document also explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is indicated as an aid in the treatment of insulin-requiring diabetes and the ACCU-CHEK Bolus Advisor component provides insulin dose recommendations, which directly contributes to the therapeutic management of the condition.
Yes
The device is described as an "in vitro diagnostic use" device, indicating its role in diagnosis. It measures quantitative glucose levels in blood, which is a diagnostic measurement. Although it specifically states it should not be used for "diagnosis or screening of diabetes," the capability to provide quantitative measurements and the "in vitro diagnostic use" designation generally classify it as a diagnostic device, albeit for monitoring rather than initial diagnosis of the condition.
No
The device description explicitly states that the system consists of a meter, test strips, and control solutions, in addition to the software component (Bolus Advisor). This indicates the presence of hardware components necessary for the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use statement explicitly states: "The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes."
Furthermore, the device description details its function of measuring glucose in fresh capillary whole blood samples, which is a classic example of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The ACCU-CHEK Aviva Expert System is indicated as an aid in the treatment of insulin-requiring diabetes. The ACCU-CHEK Aviva Expert System consists of the ACCU-CHEK Aviva Expert Meter, ACCU-CHEK Aviva Plus test strips, ACCU-CHEK Aviva control solutions, and ACCU-CHEK Bolus Advisor. The ACCU-CHEK Aviva Expert System is intended to facilitate the optimization of glycemic control in multiple daily insulin injection therapy and are under the supervision of healthcare professionals experienced in managing insulin treated patients. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used by a single person and should not be shared. The ACCU-CHEK Aviva Expert blood glucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should NOT be used with the ACCU-CHEK Aviva Expert blood glucose monitoring system. The ACCU-CHEK Aviva Expert System is intended for prescription home use only.
The ACCU-CHEK Aviva Expert meter is also indicated for the calculation of an insulin dose or carbohydrate intake based on user-entered data. The ACCU-CHEK Bolus Advisor, as a component of the Accu-Chek Aviva Expert meter, is intended for use in providing insulin dose recommendations in response to blood glucose, health events, and carbohydrate input. The ACCU-CHEK Bolus Advisor is intended to provide direction for insulin adjustment within the scope of a preplanned treatment program from a healthcare professional. Before its use, a physician or healthcare professional must prescribe the ACCU-CHEK Aviva Expert System and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the ACCU-CHEK Bolus Advisor. Once programmed, a patient must consult with his/her physician or healthcare professional before making any changes to these ACCU-CHEK Bolus Advisor settings.
Product codes (comma separated list FDA assigned to the subject device)
LFR, NDC
Device Description
The ACCU-CHEK Aviva Expert System consists of the following which was originally cleared under K131366:
- ACCU-CHEK Aviva Expert meter
- ACCU-CHEK Bolus Advisor (a component of the Aviva Expert meter)
- ACCU-CHEK Aviva Plus test strips
- ACCU-CHEK Aviva control solutions
The ACCU-CHEK Aviva Expert system is a blood glucose monitoring system that makes use of the ACCU-CHEK Aviva Plus test strips and the ACCU-CHEK Aviva control solutions.
The ACCU-CHEK Aviva Expert system provides the user with the ability to measure capillary blood glucose levels when a sample of capillary blood is applied to the test strip. The meter also provides an optional insulin bolus calculator (the ACCU-CHEK Bolus Advisor) designed for use by individuals with diabetes who require insulin. This feature is optional in that a user can simply obtain a blood glucose value through capillary blood testing and does not need to use the insulin bolus calculator portion of the system if it is not desired. For the ACCU-CHEK Aviva Expert system, this bolus calculator is meant to be used by patients with diabetes on multiple daily insulin injection (MDI) therapy. In order to calculate the appropriate bolus of insulin, the ACCU-CHEK Bolus Advisor takes the measured bG, the target bG, the carbohydrate intake, the insulin-to-carbohydrate ratio, the insulin sensitivity, health events (such as exercise), the time of day, and the active insulin into account. Before using the ACCU-CHEK Aviva Expert system, a physician or healthcare professional must provide the patient-specific target blood glucose, insulin-to-carbohydrate ration, and insulin sensitivity parameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips (for whole blood samples)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use, by people with diabetes; under the supervision of healthcare professionals
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)
Performance testing on the ACCU-CHEK Aviva Expert System that demonstrates that the device meets the performance requirements for its intended use was submitted and cleared under K131366. The ACCU-CHEK Aviva Expert System has not changed since this prior submission and the information submitted here is provided to support the clarification in the intended use statement.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Method comparison data for glucose concentrations:
- Less than 75 mg/dL:
- Within +/- 5 mg/dL: 41/48 (85.4%)
- Within +/- 10 mg/dL: 48/48 (100%)
- Within +/- 15 mg/dL: 48/48 (100%)
- Greater than or equal to 75 mg/dL:
- Within +/- 5 %: 147/252 (58.3%)
- Within +/- 10 %: 222/252 (88.1%)
- Within +/- 15 %: 246/252 (97.6%)
- Within +/- 20 %: 250/252 (99.2%)
Repeatability (within lot) precision (N=100 for each mean):
- Mean [mg/dL], SD [mg/dL], CV [%]
- 42.1, 1.2, 2.9
- 84.5, 2.2, 2.6
- 137.8, 3.3, 2.4
- 208.2, 5.6, 2.7
- 345.0, 7.9, 2.3
Reproducibility (intermediate or day-to-day) precision (N=100 for each mean):
- Control solutions, Mean [mg/dL], SD [mg/dL], CV [%]
- Low, 45.1, 1.1, 2.4
- Mid, 117.6, 2.4, 2.0
- High, 303.0, 5.1, 1.7
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ROCHE DIAGNOSTICS CORPORATION NATHAN CARRINGTON DIRECTOR OF REGULATORY AFFAIRS 9115 HAGUE ROAD INDIANAPOLIS IN 46250
December 17, 2014
Re: K142089
Trade/Device Name: ACCU-CHEK Aviva Expert Blood Glucose Monitoring system Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: LFR, NDC Dated: November 07, 2014 Received: November 12, 2014
Dear Dr. Nathan Carrington:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142089
Device Name ACCU-CHEK Aviva Expert
Indications for Use (Describe)
The ACCU-CHEK Aviva Expert System is indicated as an aid in the treatment of insulin-requiring diabetes. The ACCU-CHEK Aviva Expert System consists of the ACCU-CHEK Aviva Expert Meter, ACCU-CHEK Aviva Plus test strips, ACCU-CHEK Aviva control solutions, and ACCU-CHEK Bolus Advisor. The ACCU-CHEK Aviva Expert System is intended to facilitate the optimization of glycemic control in multiple daily insulin injection therapy and are under the supervision of healthcare professionals experienced in managing insulin treated patients. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used by a single person and should not be shared. The ACCU-CHEK Aviva Expert blood glucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should NOT be used with the ACCU-CHEK Aviva Expert blood glucose monitoring system. The ACCU-CHEK Aviva Expert System is intended for prescription home use only.
The ACCU-CHEK Aviva Expert meter is also indicated for the calculation of an insulin dose or carbohydrate intake based on user-entered data. The ACCU-CHEK Bolus Advisor, as a component of the Accu-Chek Aviva Expert meter, is intended for use in providing insulin dose recommendations in response to blood glucose, health events, and carbohydrate input. The ACCU-CHEK Bolus Advisor is intended to provide direction for insulin adjustment within the scope of a preplanned treatment program from a healthcare professional. Before its use, a physician or healthcare professional must prescribe the ACCU-CHEK Aviva Expert System and provide the patient-specific target blood glucose, insulin-tocarbohydrate ratio, and insulin sensitivity parameters to be programmed into the ACCU-CHEK Bolus Advisor. Once programmed, a patient must consult with his/her physician or healthcare professional before making any changes to these ACCU-CHEK Bolus Advisor settings.
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)
3
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4
510(k) Summary
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
| 1) Submitter name, address, contact | Roche Diagnostics Corporation
9115 Hague Rd.
Indianapolis, IN 46250
Contact Person: Nate Carrington
Ph: (317) 521-4793
email: nate.carrington@roche.com
Date Prepared: December 10, 2014 |
| ------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
| 2) Device name | Proprietary names:
ACCU-CHEK® Aviva Expert Blood Glucose Monitoring System
Classification names:
Glucose Dehydrogenase, Glucose (21 CFR 862.1345);
Class II; Product Code: LFR
Drug dosing calculator (21 CFR 868.1890);
Class II; Product Code: NDC |
| ---------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
5
3) Predicate The predicate device for this submission is the ACCU-CHEK® Aviva device Expert Blood Glucose Monitoring system, cleared in #K131366.
Predicate Device Intended Use Statement:
The ACCU-CHEK Aviva Expert System is indicated as an aid in the treatment of insulin-requiring diabetes. The ACCU-CHEK Aviva Expert System consists of the ACCU-CHEK Aviva Expert Meter, ACCU-CHEK Aviva Plus test strips, ACCU-CHEK Aviva control solutions, and ACCU-CHEK Bolus Advisor. The ACCU-CHEK Aviva Expert System is intended to facilitate the optimization of glycemic control in patients who are trained in multiple daily insulin injection therapy and are under the supervision of healthcare professionals experienced in managing insulin treated patients.
The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used by a single person and should not be shared. The ACCU-CHEK Aviva Expert blood glucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should NOT be used with the ACCU-CHEK Aviva Expert blood glucose monitoring system. The ACCU-CHEK Aviva Expert System is intended for prescription home use only.
The ACCU-CHEK Aviva Expert meter is also indicated for the calculation of an insulin dose or carbohydrate intake based on user-entered data. The ACCU-CHEK Bolus Advisor, as a component of the Accu-Chek Aviva Expert meter, is intended for use in providing insulin dose recommendations in response to blood glucose, health events, and carbohydrate input. The ACCU-CHEK Bolus Advisor is intended to provide direction for insulin adjustment within the scope of a pre-planned treatment program from a healthcare professional. Before its use, a physician or healthcare professional must prescribe the ACCU-CHEK Aviva Expert System and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the ACCU-CHEK Bolus Advisor. Once programmed, a patient must consult with his/her physician or healthcare professional before making any changes to these ACCU-CHEK Bolus Advisor settings.
6
510(k) Summary, Continued
The ACCU-CHEK Aviva Expert System consists of the following which was 4) Device Description originally cleared under K131366:
- ACCU-CHEK Aviva Expert meter ●
- ACCU-CHEK Bolus Advisor (a component of the Aviva Expert ● meter)
- . ACCU-CHEK Aviva Plus test strips
- ACCU-CHEK Aviva control solutions ●
The ACCU-CHEK Aviva Expert system is a blood glucose monitoring system that makes use of the ACCU-CHEK Aviva Plus test strips and the ACCU-CHEK Aviva control solutions.
The ACCU-CHEK Aviva Expert system provides the user with the ability to measure capillary blood glucose levels when a sample of capillary blood is applied to the test strip. The meter also provides an optional insulin bolus calculator (the ACCU-CHEK Bolus Advisor) designed for use by individuals with diabetes who require insulin. This feature is optional in that a user can simply obtain a blood glucose value through capillary blood testing and does not need to use the insulin bolus calculator portion of the system if it is not desired. For the ACCU-CHEK Aviva Expert system, this bolus calculator is meant to be used by patients with diabetes on multiple daily insulin injection (MDI) therapy. In order to calculate the appropriate bolus of insulin, the ACCU-CHEK Bolus Advisor takes the measured bG, the target bG, the carbohydrate intake, the insulin-to-carbohydrate ratio, the insulin sensitivity, health events (such as exercise), the time of day, and the active insulin into account. Before using the ACCU-CHEK Aviva Expert system, a physician or healthcare professional must provide the patient-specific target blood glucose, insulin-to-carbohydrate ration, and insulin sensitivity parameters.
Continued on next page
7
510(k) Summary, Continued
The ACCU-CHEK Aviva Expert System is indicated as an aid in the 5) Intended use treatment of insulin-requiring diabetes. The ACCU-CHEK Aviva Expert System consists of the ACCU-CHEK Aviva Expert Meter, ACCU-CHEK Aviva Plus test strips, ACCU-CHEK Aviva control solutions, and ACCU-CHEK Bolus Advisor. The ACCU-CHEK Aviva Expert System is intended to facilitate the optimization of glycemic control in patients who are trained in multiple daily insulin injection therapy and are under the supervision of healthcare professionals experienced in managing insulin treated patients. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used by a single person and should not be shared. The ACCU-CHEK Aviva Expert blood glucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should NOT be used with the ACCU-CHEK Aviva Expert blood glucose monitoring system. The ACCU-CHEK Aviva Expert System is intended for prescription home use only. The ACCU-CHEK Aviva Expert meter is also indicated for the calculation of an insulin dose or carbohydrate intake based on user-entered data. The ACCU-CHEK Bolus Advisor, as a component of the Accu-Chek Aviva Expert meter, is intended for use in providing insulin dose recommendations in response to blood glucose, health events, and carbohydrate input. The ACCU-CHEK Bolus Advisor is intended to provide direction for insulin adjustment within the scope of a pre-planned treatment program from a healthcare professional. Before its use, a physician or healthcare professional must prescribe the ACCU-CHEK Aviva Expert System and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the ACCU-CHEK Bolus Advisor. Once programmed, a patient must consult with his/her physician or healthcare professional before making any changes to these ACCU-CHEK Bolus Advisor settings.
8
510(k) Summary, Continued
| 6) Substantial
equivalence | The ACCU-CHEK® Aviva Expert System is substantially equivalent to the
ACCU-CHEK® Aviva Expert System. |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7) Data
demonstrating
substantial
equivalence | Performance testing on the ACCU-CHEK® Aviva Expert System that
demonstrates that the device meets the performance requirements for its
intended use was submitted and cleared under K131366. The ACCU-CHEK®
Aviva Expert System has not changed since this prior submission and the
information submitted here is provided to support the clarification in the
intended use statement. A data summary is provided below for convenience. |
Similarities table comparing the subject device to the predicate device
| System Feature/Claim | Detail |
|---|---|
| Test Strip | Identical: Both systems make use of the Aviva Plus test strip. |
| Test Strip Production | |
| Processes and Lot-Release | |
| Criteria | Identical: Both systems make use of the Aviva Plus test strip. |
| bG Measurement | |
| Algorithm | Identical: The fundamental scientific technology for the |
| measurement of blood glucose has not changed from the | |
| predicate. | |
| Meter Main Integrated | |
| Circuit Board | Identical: The firmware components and layout are |
| identical between the two meters. | |
| Meter Display Module, | |
| Display Frame, and Button | |
| Module | Identical: The same display unit, display frame, and button |
| unit are used by the two meters. | |
| Meter Housing and Battery | |
| Contacts | Identical: For both meters, the plastic parts are produced |
| by the same molding tool using the same material, and the | |
| battery contacts are the same. | |
| Meter Production | |
| Environment | Identical: Both meters are produced on one production |
| line/process. | |
| Underdose Detection and | |
| Meter Failsafes | Identical: The fundamental scientific technology for the |
| measurement of blood glucose has not changed from the | |
| predicate. | |
| Integrity Check for Strip | Identical: Early in the measurement sequence, the meter |
| measures the resistance of the gold on the un-dosed strip to | |
| assure that it has been properly inserted and that the quality | |
| is not compromised. The meter measures the background | |
| conductivity and electrical current prior to dosing to assure | |
| that the reagent quality is not compromised or that the strip | |
| was not prematurely dosed. | |
| Insulin Bolus Calculator | |
| Algorithm | Identical: Both systems use the exact same bolus |
| calculator, the ACCU-CHEK Bolus Advisor, for insulin | |
| dosing calculations. | |
| Test Principle | Identical: Amperometric Detection |
| Enzyme | Identical: Mut. Q-GDH |
| Sample Hematocrit | Identical: 10 to 65% |
| Maximum Altitude | Identical: 10,000 feet |
| Measuring Range | Identical: 20 – 600 mg/dL |
| Sample Volume | Identical: 0.6 μL |
| Test Time | Identical: 5 seconds |
| Operating Temperature and | |
| Relative Humidity | Identical: 14 to 38°C |
| (57 to 100°F) | |
| 10 to 80% r.h. | |
| Coding | Identical: Code key insertion |
| Precision | Identical: For response targets below 75 mg/dL, the SD is |
| $\leq$ 5.0 mg/dL, and for response targets $\geq$ 75 mg/dL, the CV | |
| is $\leq$ 5.0%. | |
| Double Dosing | Identical: Not allowed |
| Alternate Site Testing | Identical: Not allowed |
| Closed and Open Vial Shelf | |
| Life Stability | Identical: 18 months |
| Control Solutions | Identical: Aqueous, 2 levels, uses ACCU-CHEK Aviva |
| Control Solutions | |
| Primary Packaging | Identical: Standard flip top vial |
| Handling | Identical: Automatic on/off with strip insertion or by pressing button |
| Dimensions | Identical: 3.7 x 2.1 x 1 in LWH; approximately 3.6 oz. with batteries inserted |
| Data Transfer | Identical: Infrared |
| Date Reminders | Identical |
| bG Test Reminders | Identical |
| Alarm Clock Reminders | Identical |
| Target bG Levels | Identical |
| Health Events | Identical |
| Electronic Diary | Identical |
| Limitations of Procedure | Identical: Galactose >15 mg/dL will cause overestimation of blood glucose results. |
| Identical: Lipemic Samples >1800 mg/dL | |
| Identical: Intravenous administration of ascorbic acid which results in blood concentrations of ascorbic acid >3 mg/dL will cause overestimation of blood glucose results | |
| RF Wireless Capability | Identical: No |
| Measurement Units of Insulin Bolus Result Calculations | Identical: 0.5 units (appropriate for syringe/pen administration of insulin) |
| Basal Insulin* | Identical: Diary feature for tracking basal insulin |
| User Group | Identical: Diabetes patients treated with multiple daily insulin injection (MDI) therapy |
9
10
- The basal insulin values that are recorded do not influence the bolus advice.
11
Data demonstrating substantial equivalence
Performance testing on the ACCU-CHEK Aviva Expert System demonstrated that the device meets the performance requirements for its intended use.
Below is the method comparison data for the system:
Results for glucose concentrations less than 75 mg/dL
| Within +5 mg/dL | Within +10 mg/dL | Within + 15 mg/dL |
|---|---|---|
| 41/48 (85.4%) | 48/48 (100%) | 48/48 (100%) |
Results for glucose concentrations greater than or equal to 75 mg/dL
| Within +5 % | Within +10 % | Within + 15 % | Within + 20 % |
|---|---|---|---|
| 147/252 (58.3%) | 222/252 (88.1%) | 246/252 (97.6%) | 250/252 (99.2%) |
Below is the repeatability (wtihin lot) precision for the system:
| Blood | 1 | 2 | 3 | 4 | 5 |
|---|---|---|---|---|---|
| N | 100 | 100 | 100 | 100 | 100 |
| Mean [mg/dL] | 42.1 | 84.5 | 137.8 | 208.2 | 345.0 |
| SD [mg/dL] | 1.2 | 2.2 | 3.3 | 5.6 | 7.9 |
| CV [%] | 2.9 | 2.6 | 2.4 | 2.7 | 2.3 |
Below is the reproducibility (intermediate or day-to-day) precision for the system:
| Control solutions | Low | Mid | High |
|---|---|---|---|
| N | 100 | 100 | 100 |
| Mean [mg/dL] | 45.1 | 117.6 | 303.0 |
| SD [mg/dL] | 1.1 | 2.4 | 5.1 |
| CV [%] | 2.4 | 2.0 | 1.7 |
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Differences:
The only difference between the two devices is updated information in the meter manuals relating to recent clinical studies involving bolus calculators.
The Aviva Expert Standard Owner's Manual, Advanced Owner's Manual, and Getting Started Guide have all been updated with the following information:
Important Information About Bolus Calculators
- . The ACCU-CHEK Aviva Expert System contains the ACCU-CHEK Bolus Advisor, a bolus calculator that is intended for use in providing insulin dose recommendations in response to blood glucose, health events, and carbohydrate input.
- . Bolus calculators, such as the ACCU-CHEK Bolus Advisor, have been demonstrated to facilitate the optimization of glycemic control in patients who are trained in multiple daily insulin injection therapy and under the supervision of healthcare professionals experienced in managing insulin-treated patients. Such calculators have also been shown to reduce patient fear of hypoglycemia and improve patient confidence in diabetes management.-
-
- R Ziegler et al.: Use of an insulin bolus advisor improves glycemic control in multiple daily insulin injection (MDI) therapy patients with suboptimal glycemic control: first results from the ABACUS trial; Diabetes Care 36, 3613-3619 (2013).
-
- K Barnard et al.: Use of an automated bolus calculator reduces fear of hypoglycemia and improves confidence in dosage accuracy in patients with type 1 diabetes mellitus treated with multiple daily insulin injections; J. Diabetes Sci. Technol. 6:1, 144-149 (2012).