(119 days)
Not Found
No
The document describes a standard blood glucose monitoring system and insulin pump system. There is no mention of AI, ML, or any advanced algorithms beyond basic calculations for insulin dosing based on user input.
Yes
The ACCU-CHEK Combo System and the ACCU-CHEK Spirit Combo Insulin Pump are explicitly indicated for the "treatment of insulin requiring diabetes" and "subcutaneous delivery of insulin...for the management of diabetes mellitus," respectively. These functions directly involve treating a 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." and "The ACCU-CHEK Aviva Combo blood glucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use." This indicates it is not a diagnostic device for initial diagnosis.
No
The device description explicitly mentions hardware components such as the ACCU-CHEK Aviva meter, ACCU-CHEK Aviva Combo meter, test strips, and control solutions. While software is mentioned in the context of the ACCU-CHEK 360° Insulin Pump Configuration software and the meter's interface and control capabilities, the core device is a physical blood glucose monitoring system.
Yes, the ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is an IVD (In Vitro Diagnostic).
Here's why:
- 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)..."
- Definition of IVD: IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device measures glucose in blood samples, which fits this definition.
- "For in vitro diagnostic use" statement: The document also includes the phrase "For in vitro diagnostic use" under the ACCU-CHEK Aviva Combo system description, further reinforcing the IVD nature of the related components.
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.
The ACCU-CHEK Combo System is indicated for the treatment of insulin requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.
The ACCU-CHEK Spirit Combo Insulin Pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. The ACCU-CHEK 360° Insulin Pump Configuration software facilitates the monitoring and programming of the pump settings.
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 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 Combo blood glucose monitoring system.
The ACCU-CHEK Aviva Plus test strips are for use with the ACCU-CHEK Aviva Combo blood glucose meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The ACCU-CHEK Aviva Combo meter can also be used to interface with, and remotely control the ACCU-CHEK Spirit Combo insulin infusion pumps via radio frequency communication. 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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR, LZG, NDC
Device Description
The modified Black Code Key used in conjunction with the ACCU-CHEK® Aviva meter and the ACCU-CHEK® Aviva Combo meter.
The Black Code Key contains a universal code and can be used on all released ACCU-CHEK Aviva Plus test strip lots.
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 (for blood samples). Subcutaneous (for insulin delivery).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home testing by people with diabetes. Physician prescribed for insulin pump. Self-testing outside the body (in vitro diagnostic use). Single patient use.
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 Plus 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.
Performance testing on the ACCU-CHEK Aviva Combo 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): 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.
0
Roche > 长13)029
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
(317) 521-2110
Contact Person: Khone Saysana
Date Prepared: April 10, 2013 | AUG 09 2013 | |
| 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 | | |
| | Proprietary name: ACCU-CHEK® Aviva Combo System
Common Name: Insulin infusion pump, glucose test system, and accessories
Classification name:
Pump, infusion, insulin (21 CFR 880.5725); Class II; Product Code: LZG Glucose test system (21 CFR 862.1345); Class II; Product Code: NBW Drug dosing calculator (21 CFR 868.1890); Class II; Product Code: NDC | | |
| 3) Predicate
device | ACCU-CHEK Aviva Plus System (K101299)
ACCU-CHEK Aviva Combo System (K111353) | | |
1
| 4) Device
Description | The modified Black Code Key used in conjunction with the ACCU-CHEK®
Aviva meter and the ACCU-CHEK® Aviva Combo meter.
The Black Code Key contains a universal code and can be used on all
released ACCU-CHEK Aviva Plus test strip lots. |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5) Intended
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. |
| | 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 |
2
The ACCU-CHEK Combo System is indicated for the treatment of insulin 5) Intended requiring diabetes and for the quantitative measurement of glucose in fresh use continued capillary whole blood from the finger.
The ACCU-CHEK Spirit Combo Insulin Pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. The ACCU-CHEK 360° Insulin Pump Configuration software facilitates the monitoring and programming of the pump settings.
The ACCU-CHEK Aviva Combo blood glucose system is intended for selftesting 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 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 Combo blood glucose monitoring system.
The ACCU-CHEK Aviva Plus test strips are for use with the ACCU-CHEK Aviva Combo blood glucose meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The ACCU-CHEK Aviva Combo meter can also be used to interface with, and remotely control the ACCU-CHEK Spirit Combo insulin infusion pumps via radio frequency communication. 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.
For in vitro diagnostic use The ACCU-CHEK Aviva Combo system is intended for single patient use and should not be shared.
The modified ACCU-CHEK Aviva Plus System with Black 6) Substantial Code Key is substantially equivalent to the ACCU-CHEK Aviva Plus System equivalence (K101299).
The modified ACCU-CHEK Aviva Combo System with black code key is substantially equivalent to the ACCU-CHEK Aviva Combo System (K11353).
3
7) Data demonstrating substantial equivalence
Performance testing on the ACCU-CHEK Aviva Plus 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.
Performance testing on the ACCU-CHEK Aviva Combo 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.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0(8)2
August 9, 2013
Roche Diagnostics Corporation c/o Khone Saysana 9115 Hague Rd.. INDIANAPOLIS IN 46250
Re: K131029
Trade/Device Name: ACCU-CHEK® Aviva Combo System; ACCU-CHEK® Aviva Plus Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, LZG, NDC Dated: July 8, 2013 Received: July 10, 2013
Dear Mr. Saysana:
We have reviewed your Section 510(k) premarket notification of intent to market the device we ferenced 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). and Cosmetic Herefore, market the device. subject to the general controls provisions of the Act. The r ou may, therefore, manier the as act include requirements for annual registration, listing of general controls proficions gractice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. Teass note: Obter assess 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), If your device is classified (500 above) ... 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 I least be advised that I Dr. 3 issuance orour device complies with other requirements of the Act that I DA has made a are regulations administered by other Federal agencies. You must or any i ederal stiller and regimanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (2) CFR Parts 801 and 809); medical device reporting (reporting of CrK Fall 607), ademig (21 CFR Paris 607), good manufacturing practice requirements mental device-related adverse orches) regulation (21 CFR Part 820); and if applicable, the as set form in the quality of stone (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2-Mr. Saysana
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/Resourcesfor 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.
Sincerely 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
6
Indications for Use Form
510(k) Number: K131029 Device Name: ACCU-CHEK Aviva Plus Test 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 _____________________________________________________________________________________________________________________________________________________________ | AND | Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (Part 21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Katherine Serrano -S
Division Sign-Off Office of In Vitro Devices and Radiologic Health
510(k): K131029
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7
Indications for Use Form
510(k) Number: K131029 Device Name: ACCU-CHEK Aviva Combo System
Indications for Use:
The ACCU-CHEK Combo System is indicated for the treatment of insulin requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.
The ACCU-CHEK Spirit Combo Insulin Pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. The ACCU-CHEK 360° Insulin Pump Configuration software facilitates the monitoring and programming of the pump settings.
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 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 Combo blood glucose monitoring system.
The ACCU-CHEK Aviva Plus test strips are for use with the ACCU-CHEK Aviva Combo blood glucose meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
Page 1 of 2
8
The ACCU-CHEK Aviva Combo meter can also be used to interface with, and remotely control the ACCU-CHEK Spirit Combo insulin infusion pumps via radio frequency communication. 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.
For in vitro diagnostic use
The ACCU-CHEK Aviva Combo system is intended for single patient use and should not be shared.
Prescription Use __ XX___ (Part 21 CFR 801 Subpart D) AND
Over-The-Counter Use _ (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Katherine Serrano -S
Division Sign-Off Office of In Vitro Devices and Radiologic Health
510(k): K131029
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