The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).

The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

Device Description

The modified test strip is a blood glucose testing product used in conjunction with the ACCU-CHEK® Aviva meter.

Through the use of molecular-cloning techniques, Roche has modified the GDH enzyme to improve specificity for glucose; the modified reaction is referred to hereafter as Mut. Q-GDH.

The newly advanced test strip measures blood glucose rapidly and reliably via an electrochemical detection technique. The new version of the test strip employs a disposable dry reagent based on the Mut. Q-GDH method for glucose determination.

When a drop of blood is applied to the test strip, modified glucose dehydrogenase catalyzes the oxidation of glucose. During the reaction, electrons are transferred via the coenzyme PQQ and an electrochemical mediator to the surface of the electrode. Current generated by the reaction is proportional to the concentration of glucose present in the blood sample.

The single-patient use ACCU-CHEK Aviva Blood Glucose Monitoring System will consist of:

Meter: ACCU-CHEK Aviva Meter
Test Strip: ACCU-CHEK Aviva Plus Test Strip
Controls: ACCU-CHEK Aviva Control Solutions

AI/ML Overview

The provided text describes the ACCU-CHEK Aviva Plus Blood Glucose Monitoring System and its substantial equivalence determination. However, it does not include detailed information regarding specific acceptance criteria, a comprehensive study report with quantitative performance data (beyond the general statement of meeting performance requirements), sample sizes for test/training sets, expert qualifications, or details about ground truth establishment.

Based only on the provided text, here's what can be extracted and what remains unknown regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Performance testing on the ACCU-CHEK Aviva System demonstrated that the device meets the performance requirements for its intended use." However, it does not explicitly list the specific acceptance criteria (e.g., accuracy percentages, bias limits) or numerical reported device performance against those criteria.

Acceptance Criteria (Not explicitly stated in the document)	Reported Device Performance (General statement)
Specific accuracy metrics and thresholds for blood glucose measurement are not provided.	"The device meets the performance requirements for its intended use."
Specific precision metrics are not provided.	"The data demonstrates that the test strip is substantially equivalent to the predicate device."

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

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

Not specified in the provided text.

4. Adjudication Method for the Test Set

Not specified in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Was a MRMC study done? Not mentioned. The device is a blood glucose monitoring system, which typically involves a single user and an automated result, not multiple human readers interpreting results. Therefore, an MRMC study is highly unlikely for this type of device.
Effect size of human readers with/without AI assistance: Not applicable, as this is not an AI-assisted diagnostic imaging or interpretation device.

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

The device itself is a standalone system for measuring blood glucose. The "algorithm" here refers to the electrochemical detection technique and modified enzyme chemistry. The performance testing would inherently be standalone, as it measures the device's output given a sample. The document states, "Performance testing on the ACCU-CHEK Aviva System demonstrated that the device meets the performance requirements for its intended use." This implies a standalone evaluation.

7. The Type of Ground Truth Used

While not explicitly stated, for a blood glucose monitoring system, the ground truth for testing would typically be established by a laboratory reference method (e.g., a YSI analyzer or similar highly accurate laboratory-grade glucose measurement instrument).

8. The Sample Size for the Training Set

Not specified in the provided text. (It's worth noting that for this type of electrochemical device, "training set" might not be directly analogous to machine learning model training. Instead, it refers to the data used during the development and optimization of the chemical and hardware components, which isn't detailed here).

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

Not specified in the provided text. (Similar to point 8, this would likely involve comparison to laboratory reference methods during development).

Summary of Missing Information:

The provided text serves as a 510(k) summary, which outlines the device's purpose and its substantial equivalence to a predicate device. It primarily focuses on the regulatory aspects and a high-level description of the technology. It does not include the granular details of the performance study design, specific acceptance criteria values, quantitative performance results, sample sizes for testing/training, or details about ground truth establishment that would typically be found in a full study report or detailed submission. The statement "Performance testing... demonstrated that the device meets the performance requirements" is a conclusion, not a detailed presentation of the data itself.

Summary

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Image /page/0/Picture/0 description: The image shows the word "Roche" in bold black letters inside of a hexagon. The hexagon is outlined in black. The word is centered inside of the hexagon.

SEP 2 1 2011

510(k) Summary

KI01299 ______________________________________________________________________________________________________________________________________________________________________

Introduction	According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence.
1) Submittername,address,contact	Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 521-2110Contact Person: Mike FlisDate Prepared: August 03, 2011
2) Devicename	Proprietary name:ACCU-CHEK® Aviva Plus Blood Glucose MonitoringSystemMeter: ACCU-CHEK Aviva MeterTest Strip: ACCU-CHEK Aviva Plus Test StripControls: ACCU-CHEK Aviva Control SolutionsClassification name: Glucose dehydrogenase, glucose test system(21 C.F.R. § 862.1345)NBW, Blood Glucose Test System, Over-the-CounterLFR, Glucose Dehydrogenase
3) Predicatedevice	ACCU-CHEK Aviva System (K060620 and K043474)

Continued on next page

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510(k) Summary, Continued

Device The modified test strip is a blood glucose testing product used in conjunction Description with the ACCU-CHEK® Aviva meter.

Through the use of molecular-cloning techniques, Roche has modified the GDH enzyme to improve specificity for glucose; the modified reaction is referred to hereafter as Mut. Q-GDH.

Continued on next page

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510(k) Summary, Continued

The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended 5) Intended use to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

The single-patient use ACCU-CHEK Aviva Blood Glucose Monitoring System will consist of:

Meter: ACCU-CHEK Aviva Meter Test Strip: ACCU-CHEK Aviva Plus Test Strip Controls: ACCU-CHEK Aviva Control Solutions

6) Substantial equivalence

The modified ACCU-CHEK Aviva Plus Test System is substantially equivalent to the ACCU-CHEK Aviva System (K060620 and K043474).

Data demonstrati ng substantial equivalence

Performance testing on the ACCU-CHEK Aviva System demonstrated that the device meets the performance requirements for its intended use. The data demonstrates that the test strip is substantially equivalent to the predicate device.

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Public Health Service

Image /page/3/Picture/2 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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, featuring three wing-like shapes.

Food and Drug Administrati 10903 New Hampshire Avenue Silver Spring, MD 20993

SEP ? 1 2011

Roche Diagnostics c/o Mike Flis Regulatory Affairs Program Manager 9115 Hague Road Indianapolis. IN. 46250-0457

Re: K101299 Trade Name: ACCU-CHEK Aviva Plus Blood Glucose Monitoring System Regulation Number: 21 CFR $862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Codes: NBW. LFR. JJX Dated: September 16, 2011 Received: September 19, 2011

Dear Mr. Flis:

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.

If your device is classified (see above) into either class II (Special Controls) or class 111 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please nate the regulation entitled, "Misbranding by reference to premarket noufication" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 for (1 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/orYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K101299 Device Name: ACCU-CHEK Aviva Plus Blood Glucose Monitoring System

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND

Over-The-Counter Use XX (Part 21 CFR 801 Subpart C) ুন সম্ম

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Ruth Chaler

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k \ 0'2 qq

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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.