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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the performance of the ACCU-CHEK Aviva Expert Blood Glucose Monitoring system:

The document describes the ACCU-CHEK Aviva Expert Blood Glucose Monitoring system and refers to performance testing that was submitted and cleared under a previous 510(k) (K131366). The current submission (K142089) states that "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." Therefore, the performance data presented is for the identical device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document presents performance data as evidence of the device meeting requirements for its intended use, but does not explicitly state predetermined "acceptance criteria" as separate rows. However, to construct a table, we can infer the acceptance criteria from the reported results, assuming the reported values met the relevant regulatory standards for blood glucose monitoring systems at the time of clearance.

Performance Metric	Acceptance Criteria (Inferred from common BGM standards)	Reported Device Performance
Accuracy (Glucose Concentrations < 75 mg/dL)	Within ±5 mg/dL	85.4% (41/48 samples)
	Within ±10 mg/dL	100% (48/48 samples)
	Within ±15 mg/dL	100% (48/48 samples)
Accuracy (Glucose Concentrations ≥ 75 mg/dL)	Within ±5%	58.3% (147/252 samples)
	Within ±10%	88.1% (222/252 samples)
	Within ±15%	97.6% (246/252 samples)
	Within ±20%	99.2% (250/252 samples)
Repeatability (Within-lot precision)	SD ≤ 5.0 mg/dL for < 75 mg/dL, CV ≤ 5.0% for ≥ 75 mg/dL	Sample-specific:
Blood Sample 1 (Mean 42.1 mg/dL)		SD: 1.2 mg/dL, CV: 2.9%
Blood Sample 2 (Mean 84.5 mg/dL)		SD: 2.2 mg/dL, CV: 2.6%
Blood Sample 3 (Mean 137.8 mg/dL)		SD: 3.3 mg/dL, CV: 2.4%
Blood Sample 4 (Mean 208.2 mg/dL)		SD: 5.6 mg/dL, CV: 2.7%
Blood Sample 5 (Mean 345.0 mg/dL)		SD: 7.9 mg/dL, CV: 2.3%
Reproducibility (Intermediate/Day-to-day precision)	SD and CV values likely within established professional standards for BGM systems	Control Solution-specific:
Low Control (Mean 45.1 mg/dL)		SD: 1.1 mg/dL, CV: 2.4%
Mid Control (Mean 117.6 mg/dL)		SD: 2.4 mg/dL, CV: 2.0%
High Control (Mean 303.0 mg/dL)		SD: 5.1 mg/dL, CV: 1.7%

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Accuracy Test):
- Glucose concentrations < 75 mg/dL: 48 samples
- Glucose concentrations ≥ 75 mg/dL: 252 samples
- Total for accuracy: 300 samples
Sample Size (Repeatability Test): 100 measurements for each of 5 blood samples (Total 500 measurements)
Sample Size (Reproducibility Test): 100 measurements for each of 3 control solutions (Total 300 measurements)
Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It only states that performance testing was done on the system.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide any information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for the test set. For blood glucose monitoring systems, ground truth is typically established by a highly accurate laboratory reference method (e.g., YSI analyzer) rather than expert consensus on readings.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set. Given that it's a quantitative measurement device, adjudication by experts (as in imaging) is typically not applicable; instead, the device's readings are compared directly against a reference method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, the provided document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study design is not typically applicable to a standalone blood glucose monitoring system, which provides a direct quantitative measurement rather than requiring human interpretation of complex data (like medical images).
Effect Size of Human Reader Improvement with AI: Not applicable, as no MRMC study or "human reader" component in the traditional sense is described for this device. The "Bolus Advisor" is an automated calculation based on user input and measured BG, not an AI assisting human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the performance data presented (accuracy, repeatability, reproducibility) represents the standalone performance of the ACCU-CHEK Aviva Expert Blood Glucose Monitoring system. It measures glucose concentration without human interpretation of the measurement itself, and the bolus advisor function is an algorithm-only component calculating insulin dose based on provided inputs. The performance of the Bolus Advisor algorithm itself would have been validated separately as part of the K131366 clearance (though details are not provided here).

7. The Type of Ground Truth Used

The ground truth used for the accuracy assessment is strongly implied to be a laboratory reference method for glucose measurement, which is standard for blood glucose monitoring systems. The document states "method comparison data," which means the device's readings were compared against another, more accurate method. While not explicitly named, the "method comparison" implies a highly precise and accurate lab instrument (e.g., YSI glucose analyzer) as the ground truth.

8. The Sample Size for the Training Set

The document does not specify any training set sample size. This is because the device described is a blood glucose monitoring system with a fixed algorithm for glucose measurement and a predefined calculation for the bolus advisor. These types of devices generally do not involve machine learning "training" in the way that an AI diagnostic algorithm might. The algorithms are built on known chemical and mathematical principles.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, the concept of a "training set" with associated ground truth, as used in machine learning, does not align with the description of this device. The underlying principles for glucose measurement and insulin dose calculation are based on established scientific and medical models, rather than learned patterns from a training dataset.

Summary

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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.

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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

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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 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)

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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 Corporation9115 Hague Rd.Indianapolis, IN 46250Contact Person: Nate CarringtonPh: (317) 521-4793email: nate.carrington@roche.comDate Prepared: December 10, 2014
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2) Device name	Proprietary names:ACCU-CHEK® Aviva Expert Blood Glucose Monitoring SystemClassification names:Glucose Dehydrogenase, Glucose (21 CFR 862.1345);Class II; Product Code: LFRDrug dosing calculator (21 CFR 868.1890);Class II; Product Code: NDC
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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 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.

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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.

Continued on next page

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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.

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510(k) Summary, Continued

6) Substantialequivalence	The ACCU-CHEK® Aviva Expert System is substantially equivalent to theACCU-CHEK® Aviva Expert System.
7) Datademonstratingsubstantialequivalence	Performance testing on the ACCU-CHEK® Aviva Expert System thatdemonstrates that the device meets the performance requirements for itsintended use was submitted and cleared under K131366. The ACCU-CHEK®Aviva Expert System has not changed since this prior submission and theinformation submitted here is provided to support the clarification in theintended use statement. A data summary is provided below for convenience.

6) Substantialequivalence

The ACCU-CHEK® Aviva Expert System is substantially equivalent to theACCU-CHEK® Aviva Expert System.

7) Datademonstratingsubstantialequivalence

Performance testing on the ACCU-CHEK® Aviva Expert System thatdemonstrates that the device meets the performance requirements for itsintended use was submitted and cleared under K131366. The ACCU-CHEK®Aviva Expert System has not changed since this prior submission and theinformation submitted here is provided to support the clarification in theintended 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 ProductionProcesses and Lot-ReleaseCriteria	Identical: Both systems make use of the Aviva Plus test strip.
bG MeasurementAlgorithm	Identical: The fundamental scientific technology for themeasurement of blood glucose has not changed from thepredicate.
Meter Main IntegratedCircuit Board	Identical: The firmware components and layout areidentical between the two meters.
Meter Display Module,Display Frame, and ButtonModule	Identical: The same display unit, display frame, and buttonunit are used by the two meters.
Meter Housing and BatteryContacts	Identical: For both meters, the plastic parts are producedby the same molding tool using the same material, and thebattery contacts are the same.
Meter ProductionEnvironment	Identical: Both meters are produced on one productionline/process.
Underdose Detection andMeter Failsafes	Identical: The fundamental scientific technology for themeasurement of blood glucose has not changed from thepredicate.
Integrity Check for Strip	Identical: Early in the measurement sequence, the metermeasures the resistance of the gold on the un-dosed strip toassure that it has been properly inserted and that the qualityis not compromised. The meter measures the backgroundconductivity and electrical current prior to dosing to assurethat the reagent quality is not compromised or that the stripwas not prematurely dosed.
Insulin Bolus CalculatorAlgorithm	Identical: Both systems use the exact same boluscalculator, the ACCU-CHEK Bolus Advisor, for insulindosing 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 andRelative 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 CVis $\leq$ 5.0%.
Double Dosing	Identical: Not allowed
Alternate Site Testing	Identical: Not allowed
Closed and Open Vial ShelfLife Stability	Identical: 18 months
Control Solutions	Identical: Aqueous, 2 levels, uses ACCU-CHEK AvivaControl 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/dLIdentical: 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

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The basal insulin values that are recorded do not influence the bolus advice.

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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.-
1. 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).
1. 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).

Regulation Number and Section

§ 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.