(499 days)
No
The description focuses on electrochemical detection and enzyme-based reactions, with no mention of AI or ML.
No
The device is a blood glucose monitoring system, which is used for measurement and diagnosis, not for treatment or therapy. It aids in monitoring the effectiveness of diabetes control, but does not directly treat the condition.
No.
Explanation: The "Intended Use / Indications for Use" section explicitly states, "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."
No
The device description explicitly mentions hardware components like a meter, test strips, and control solutions, and describes an electrochemical detection technique involving physical reactions on the test strip.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why, based on the provided text:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "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..."
- Definition of IVD: An in vitro diagnostic device is a medical device intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes. This device fits this definition as it measures glucose in blood samples outside the body to monitor diabetes.
- Device Description: The description details how the device works by analyzing a blood sample using an electrochemical detection technique, which is a common method for in vitro diagnostics.
Therefore, the ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is clearly identified and described as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
NBW, LFR, JJX
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertips, forearm, upper arm, or palm.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Single person with diabetes at home (self-testing).
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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 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
(317) 521-2110
Contact Person: Mike Flis
Date Prepared: August 03, 2011 |
| 2) Device
name | Proprietary name:
ACCU-CHEK® Aviva Plus Blood Glucose Monitoring
System
Meter: ACCU-CHEK Aviva Meter
Test Strip: ACCU-CHEK Aviva Plus Test Strip
Controls: ACCU-CHEK Aviva Control Solutions
Classification name: Glucose dehydrogenase, glucose test system
(21 C.F.R. § 862.1345)
NBW, Blood Glucose Test System, Over-the-Counter
LFR, Glucose Dehydrogenase |
| 3) Predicate
device | ACCU-CHEK Aviva System (K060620 and K043474) |
Continued on next page
1
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.
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.
Continued on next page
2
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.
3
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).
4
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,
AJ
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
5
Indications for Use Statement
510(k) Number (if known): K101299 Device Name: ACCU-CHEK Aviva Plus Blood Glucose Monitoring System
Indications for Use:
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.
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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