(236 days)
No
The summary describes a standard blood glucose monitoring system with added connectivity features (USB and BLE). There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
No
The device is used to monitor blood glucose levels, which aids in monitoring the effectiveness of diabetes control, but it does not directly treat or provide therapy for the condition.
No
The "Intended Use" section explicitly states that the device "should not be used for the diagnosis of or screening of diabetes." It is intended as an aid to monitor the effectiveness of diabetes control for people already diagnosed with diabetes.
No
The device description explicitly states it is a "blood glucose monitoring system that makes use of the ACCU-CHEK Aviva Connect meter, the ACCU-CHEK Aviva Plus test strips, and the ACCU-CHEK Aviva control solutions," all of which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The ACCU-CHEK Aviva Connect Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use)..."
- Definition of IVD: An IVD is a medical device used to examine specimens, such as blood, taken from the human body to provide information for diagnosis, monitoring, or screening. This device fits that description by measuring glucose in blood samples.
- "For in vitro diagnostic use" statement: The "Intended Use / Indications for Use" section also includes the clear statement "For in vitro diagnostic use".
Therefore, based on the provided text, the ACCU-CHEK Aviva Connect Blood Glucose Monitoring System is an IVD.
N/A
Intended Use / Indications for Use
The ACCU-CHEK Aviva Connect 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. The ACCU-CHEK Aviva Connect Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The ACCU-CHEK Aviva Connect 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 Connect Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Connect Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
Product codes
NBW, LFR
Device Description
The ACCU-CHEK Aviva Connect blood glucose monitoring system is a blood glucose monitoring system that makes use of the ACCU-CHEK Aviva Connect meter, the ACCU-CHEK Aviva Plus test strips (K101299), and the ACCU-CHEK Aviva control solutions (K101299). The ACCU-CHEK Aviva Connect meter is a modification of the ACCU-CHEK Aviva meter (K133862) with an improved design and the addition of a USB port and the BLE communication capability.
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 at home
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 Connect System demonstrated that the device meets the performance requirements for its intended use. The data demonstrates that the ACCU-CHEK Aviva Connect System is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2015
ROCHE DIAGNOSTICS KHONE SAYSANA PRINCIPLE REGULATORY AFFAIRS, DIABETES CARE 9115 HAGUE ROAD INDIANAPOLIS IN 46250
Re: K141867
Trade/Device Name: ACCU-CHEK® Aviva Connect Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. LFR Dated: February 2, 2015 Received: February 3, 2015
Dear Khone Saysana:
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.
1
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,
Stayce Beck -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
2
Indications for Use
510(k) Number (if known) K141867
Device Name
ACCU-CHEK Aviva Connect Blood Glucose Monitoring System
Indications for Use (Describe)
The ACCU-CHEK Aviva Connect 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. The ACCU-CHEK Aviva Connect Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The ACCU-CHEK Aviva Connect 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 Connect Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Connect Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
For in vitro diagnostic use
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the Roche logo. The logo consists of the word "Roche" in bold, sans-serif font, centered within a black-outlined hexagon. The background is white.
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. |
|---|---|
| Submitter | |
| Name, Address, | |
| Contact | Roche Diagnostics Corporation |
| 9115 Hague Rd. | |
| Indianapolis, IN 46250 | |
| (317) 521-7593 | |
| Contact Person: Khone Saysana | |
| Date Prepared: February 6, 2015 | |
| Device Name | Proprietary name: |
| ACCU-CHEK® Aviva Connect Blood Glucose Monitoring System | |
| Meter: ACCU-CHEK Aviva Connect 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); Class II | |
| NBW, Blood Glucose Test System, Over-the-Counter | |
| LFR, Glucose Dehydrogenase | |
| Predicate | |
| Device | ACCU-CHEK Aviva Plus System (K133862), concurrence received on 30 April 2014. |
| Device | |
| Description | The ACCU-CHEK Aviva Connect blood glucose monitoring system is a blood glucose monitoring system that makes use of the ACCU-CHEK Aviva Connect meter, the ACCU- |
| CHEK Aviva Plus test strips (K101299), and the ACCU-CHEK Aviva control solutions (K101299). The ACCU-CHEK Aviva Connect meter is a modification of the ACCU-CHEK Aviva meter (K133862) with an improved design and the addition of a USB port and the BLE communication capability. |
4
| Summary of
Technological
Characteristics
Compared to
the Predicate
Device | System Feature | ACCU-CHEK Aviva Plus System
(K133862, predicate) | ACCU-CHEK Aviva
Connect System
(new device) |
|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| | 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. The ACCU-CHEK
Aviva Plus Blood Glucose Monitoring System
is intended to be used by a single person and
should not be shared. | Same |
| | | 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. | |
| | | The ACCU-CHEK Aviva Plus Test Strips are
for use with the ACCU-CHEK Aviva Plus
Blood Glucose Meter to quantitatively measure
glucose (sugar) in fresh capillary whole blood
samples drawn from the fingertips. | |
| | Meter
Communication | Infrared Communication via
dongle | USB (Universal Serial
Bus) and
BLE (Blue Tooth Low
Energy)
Communications |
| | AST Claims | Palm, Upper Arm and Forearm | None |
| | Meter Buttons | Arrow buttons on the front are
used to toggle through memory | Button functionality
has changed |
| | Embedded PC
Reports | No | Embedded Reports
available for
transmission to a
Personal
Computer |
| | Meter Housing | Black housing | Modified black housing |
| | Test Strip | Utilizes the ACCU-CHEK Aviva Plus test strip | Same |
| | Meter Coding | Universal code or blood glucose measurement
parameters are programmed into an internal
EEPROM | Same |
| System Feature | ACCU-CHEK Aviva Plus System
(K133862, predicate) | ACCU-CHEK Aviva
Connect System
(new device) | |
| Test Principle | Amperometric Detection | Same | |
| Enzyme | Mut. Q-GDH | Same | |
| Sample
Hematocrit | 10 to 65% | Same | |
| Maximum
Altitude | 10,000 feet | Same | |
| Measuring
Range | 20 - 600 mg/dL | Same | |
| Sample Volume | 0.6 µL | Same | |
| Test Time | 5 seconds | Same | |
| Operating
Temperature
and Relative
Humidity | (57 to 100°F)
10 to 80% r.h. | Same | |
| Precision | For response targets 15 mg/dL will cause overestimation
of blood glucose results. | Same | |
| | Lipemic Samples >1800 mg/dL | Same | |
| | Intravenous administration of ascorbic acid
which results in blood concentrations of
ascorbic acid >3 mg/dL will cause
overestimation of blood glucose results. | Same | |
| | If peripheral circulation is impaired, collection
of fresh capillary whole blood from the
approved sample sites is not advised as the
results might not be a true reflection of the
physiological blood glucose level. This may
apply in the following circumstances: severe
dehydration as a result of diabetic ketoacidosis
or due to hyperglycemic hypersmolar non-
ketotic syndrome, hypotension, shock,
decompensated heart failure, NYHA Class IV,
or peripheral arterial occlusive disease | Same | |
5
Summary of Technological Characteristics Compared to the Predicate
Device
6
| Intended Use | The ACCU-CHEK Aviva Connect 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. The ACCU-CHEK Aviva Connect Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. |
|---|---|
| The ACCU-CHEK Aviva Connect 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 Connect Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. | |
| The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Connect Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. | |
| The single-patient use ACCU-CHEK Aviva Connect Blood Glucose Monitoring System will consist of: | |
| Meter: ACCU-CHEK Aviva Connect Meter Test Strip: ACCU-CHEK Aviva Plus Test Strip Controls: ACCU-CHEK Aviva Control Solutions | |
| Substantial Equivalence | The ACCU-CHEK Aviva Connect system is substantially equivalent to the ACCU-CHEK Aviva Plus System (K133862). |
| Data demonstrating substantial equivalence | Performance testing on the ACCU-CHEK Aviva Connect System demonstrated that the device meets the performance requirements for its intended use. The data demonstrates that the ACCU-CHEK Aviva Connect System is substantially equivalent to the predicate device. |