(151 days)
No
The device description mentions a "bolus calculator algorithm" which takes user-entered data and measured blood glucose to provide insulin dose recommendations based on pre-programmed parameters. This is a rule-based algorithm, not indicative of AI/ML which typically involves learning from data. There is no mention of AI, ML, or training/test data sets.
Yes
The device is indicated as an aid in the treatment of insulin-requiring diabetes, and its Bolus Advisor component provides insulin dose recommendations, which directly support therapeutic intervention.
No
The text explicitly states: "The ACCU-CHEK Aviva Expert blood glucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use."
No
The device is described as a "system" consisting of a meter, test strips, control solutions, and a bolus advisor (which is a component of the meter). This clearly includes hardware components (meter, test strips, control solutions) in addition to the software (bolus advisor).
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes."
This statement directly identifies the device as being intended for in vitro diagnostic use.
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 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 giucose 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 giucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Altemative 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 glucase, 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
LFR, NDC
Device Description
The ACCU-CHEK Aviva Expert System consists of the following:
- ACCU-CHEK Aviva Expert meter .
- ACCU-CHEK Bolus Advisor (a component of the Aviva Expert meter) .
- . ACCU-CHEK Aviva Plus test strips (K101299)
- ACCU-CHEK Aviva control solutions (K043474) .
The ACCU-CHEK Aviva Expert system is a blood glucose monitoring system that makes use of the ACCU-CHEK Aviva Plus test strips (cleared under K101299) and the ACCU-CHEK Aviva control solutions (cleared under K043474). The industrial design of the ACCU-CHEK Aviva Expert meter is nearly identical to that of the ACCU-CHEK Aviva Combo meter (cleared under kl 11353); the only difference between the two devices is that the ACCU-CHEK Aviva Expert meter does not have Bluetooth wireless capability and therefore cannot be connected to an insulin pump, whereas the ACCU-CHEK Aviva Combo meter does have Bluetooth capability and can be connected to an insulin pump.
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. The insulin bolus calculator algorithm is identical to the bolus calculator algorithm that was cleared during the Aviva Combo 510(k) submission (K111353). 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, insulinto-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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self-testing outside the body (in vitro diagnostic use) by people with diabetes; prescription home use only. Users are trained in multiple daily insulin injection therapy and are under the supervision of healthcare professionals experienced in managing insulin treated patients. A physician or healthcare professional must prescribe the system and provide patient-specific parameters.
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 demonstrated that the device meets the performance requirements for its intended use. The data demonstrate that the system is substantially equivalent to the predicate device.
Method comparison data:
Results 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%)
Results for glucose concentrations 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:
Blood Samples (N=100 for each):
1: Mean 42.1 mg/dL, SD 1.2 mg/dL, CV 2.9 %
2: Mean 84.5 mg/dL, SD 2.2 mg/dL, CV 2.6 %
3: Mean 137.8 mg/dL, SD 3.3 mg/dL, CV 2.4 %
4: Mean 208.2 mg/dL, SD 5.6 mg/dL, CV 2.7 %
5: Mean 345.0 mg/dL, SD 7.9 mg/dL, CV 2.3 %
Reproducibility (intermediate or day-to-day) precision:
Control solutions (N=100 for each):
Low: Mean 45.1 mg/dL, SD 1.1 mg/dL, CV 2.4 %
Mid: Mean 117.6 mg/dL, SD 2.4 mg/dL, CV 2.0 %
High: Mean 303.0 mg/dL, SD 5.1 mg/dL, CV 1.7 %
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for precision and method comparison results (agreement percentages and standard deviations/coefficients of variation).
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
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 Diagnostic Corporation 9115 Hague Rd. Indianapolis, IN 46250 (317) 521-4793 Contact Person: Nate Carrington Date Prepared: February 12, 2013
OCT
11 2013
2. Device Name
Proprietary names:
ACCU-CHEK Aviva Expert System ACCU-CHEK Aviva Plus Test Strip ACCU-CHEK Bolus Advisor ACCU-CHEK Aviva Expert Meter
Classification name: Glucose dehydrogenase, glucose test system (21 C.F.R. § 862.1345); Class II
Classification name: Drug dosing calculation (21 C.F.R. § 868.1890); Class II
LFR, Glucose Dehydrogenase NDC, Drug Dosing Calculator
3. Predicate Device
ACCU-CHEK Aviva Combo meter, cleared as a component of the ACCU-CHEK Combo System in #K111353
The ACCU-CHEK Aviva Combo blood glucose system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control. The ACCU-CHEK Aviva Combo meter is also indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data.
1
4. Device Description
The ACCU-CHEK Aviva Expert System consists of the following:
- ACCU-CHEK Aviva Expert meter .
- ACCU-CHEK Bolus Advisor (a component of the Aviva Expert meter) .
- . ACCU-CHEK Aviva Plus test strips (K101299)
- ACCU-CHEK Aviva control solutions (K043474) .
The ACCU-CHEK Aviva Expert system is a blood glucose monitoring system that makes use of the ACCU-CHEK Aviva Plus test strips (cleared under K101299) and the ACCU-CHEK Aviva control solutions (cleared under K043474). The industrial design of the ACCU-CHEK Aviva Expert meter is nearly identical to that of the ACCU-CHEK Aviva Combo meter (cleared under kl 11353); the only difference between the two devices is that the ACCU-CHEK Aviva Expert meter does not have Bluetooth wireless capability and therefore cannot be connected to an insulin pump, whereas the ACCU-CHEK Aviva Combo meter does have Bluetooth capability and can be connected to an insulin pump.
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. The insulin bolus calculator algorithm is identical to the bolus calculator algorithm that was cleared during the Aviva Combo 510(k) submission (K111353). 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, insulinto-carbohydrate ration, and insulin sensitivity parameters.
5. Intended Use
The ACCU-CHEK Aviva Expert System is indicated as an aid in the treatment of insulinrequiring 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.
510(k) Summary
2
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 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-carboyhydrate 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. Substantial Equivalence
The ACCU-CHEK Aviva Expert System is substantially equivalent to the ACCU-CHEK Aviva Combo System. Below is a table that provides a comparison between the ACCU-CHEK Aviva Expert System and its predicate device.
510(k) Summary
3
Similarities Table
| 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. |
.
:
·
4
Similarities Table (continued)
| System
Feature/Claim | ACCU-CHEK Aviva Expert
Meter with Aviva Plus
Test Strip | ACCU-CHEK Combo Meter
with Aviva Plus Test Strip
Predicate
(K111353) |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Quantitative measurement of
glucose (sugar) in capillary blood
from the finger tip, indicated for
diabetes management by
calculating an insulin dose or
carbohydrate intake | Quantitative measurement of
glucose (sugar) in capillary blood
from the finger tip, indicated for
diabetes management by
calculating an insulin dose or
carbohydrate intake |
| Test Principle | Amperometric Detection | Amperometric Detection |
| Enzyme | Mut. Q-GDH | Mut. Q-GDH |
| Sample
Hematocrit | 10 to 65% | 10 to 65% |
| Maximum
Altitude | 10,000 feet | 10,000 feet |
| Measuring Range | 20 - 600 mg/dL | 20 - 600 mg/dL |
| Sample Volume | 0.6 µL | 0.6 µL |
| Test Time | 5 seconds | 5 seconds |
| Operating
Temperature and
Relative
Humidity | 14 to 38°C
(57 to 100°F)
10 to 80% r.h. | 14 to 38°C
(57 to 100°F)
10-80% r.h. |
| Coding | Code key insertion; lot-specific
code key provided with each box
of Aviva Plus test strips | Code key insertion; lot-specific
code key provided with each box
of Aviva Plus test strips |
| Precision | For response targets below 75
mg/dL, the SD is ≤ 5.0 mg/dL,
and for response targets ≥ 75
mg/dL, the CV is ≤ 5.0%. | For response targets below 75
mg/dL, the SD is ≤ 5.0 mg/dL,
and for response targets ≥ 75
mg/dL, the CV is ≤ 5.0%. |
| Double Dosing | No | No |
| Alternate Site
Testing | No | No |
| System
Feature/Claim | ACCU-CHEK Aviva Expert
Meter with Aviva Plus
Test Strip | ACCU-CHEK Combo Meter
with Aviva Plus Test Strip
Predicate
(K111353) |
| Closed and Open
Vial Shelf Life
Stability | 18 months | 18 months |
| Control Solutions | Aqueous, 2 levels, uses ACCU-
CHEK Aviva Control Solutions | Aqueous, 2 levels, uses ACCU-
CHEK Aviva Control Solutions |
| Primary
Packaging | Standard flip top vial | Standard flip top vial |
| Handling | Automatic on/off with strip
insertion or by pressing button | Automatic on/off with strip
insertion or by pressing button |
| Dimensions | 3.7 x 2.1 x 1 in LWH;
approximately 3.6 oz. with
batteries inserted | 3.7 x 2.1 x 1 in LWH;
approximately 3.6 oz. with
batteries inserted |
| Data Transfer | Infrared | Infrared |
| Date Reminders | Yes | Yes |
| bG Test
Reminders | Yes | Yes |
| Alarm Clock
Reminders | Yes | Yes |
| Target bG Levels | Yes | Yes |
| Health Events | Yes | Yes |
| Electronic Diary | Yes | Yes |
| Limitations of
Procedure | Galactose >15 mg/dL will cause
overestimation of blood glucose
results. | Galactose >15 mg/dL will cause
overestimation of blood glucose
results. |
| | Lipemic Samples >1800 mg/dL | Lipemic Samples >1800 mg/dL |
| | Intravenous administration of
ascorbic acid which results in
blood concentrations of ascorbic
acid >3 mg/dL will cause
overestimation of blood glucose
results | Intravenous administration of
ascorbic acid which results in
blood concentrations of ascorbic
acid >3 mg/dL will cause
overestimation of blood glucose
results |
| System
Feature/Claim | ACCU-CHEK Aviva Expert
Meter with Aviva Plus
Test Strip | ACCU-CHEK Combo Meter
with Aviva Plus Test Strip
Predicate
(K111353) |
| RF Wireless
Capability | No | Yes; additional components to
satellite board for Bluetooth
communication with ACCU-
CHEK Spirit Combo insulin
infusion pumps |
| Measurement
Units of Insulin
Bolus Result
Calculations | 0.5 units (appropriate for
syringe/pen administration of
insulin) | 0.1 units (appropriate for pump
administration of insulin) |
| Basal Insulin* | Diary feature for tracking basal
insulin | Basal insulin is controlled via
pump |
| User Group | Diabetes patients treated with
multiple daily insulin injection
(MDI) therapy | Diabetes patients treated with
insulin pump therapy or multiple
daily insulin injection (MDI)
therapy |
.
:
5
Similarities Table (continued)
б
・
6
Differences Table
- The basal insulin values that are recorded do not influence the bolus advice.
7. 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. The data demonstrate that the system is substantially equivalent to the predicate device.
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%) |
510(k) Summary
7
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 |
510(k) Summary
.
8
Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract human figure with three flowing lines extending from its body, resembling a bird in flight or a flowing ribbon.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 11, 2013
Roche Diagnostics Corporation C/O Nathan A. Carrington, Ph.D. 9115 Hague Rd INDIANAPOLIS IN 46250-0457
Re: K131366
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: August 26, 2013 Received: August 29, 2013
Dear Dr. 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 conceming 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.
9
Page 2-Mr. Carrington
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/Resources/or You/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.
Sincercly 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
10
Indications for Use Form
510(k) Number (if known): K131366
Device Name: ACCU-CHEK Aviva Expert Blood Glucose Monitoring System
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 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 giucose 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 giucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Altemative 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 glucase, 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.
| Prescription Use XX | |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF |
|---|
| NEEDED) |
Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)
Stayce Beck Division Sign-Off Office of In Vitro Devices and Radiologic Health
510(k)
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