Has anyone switched to the accu chek nano? We currently use the accu chek Avila plus and like the size of the nano and if it is more accurate all the better. If you have switched what dou you think about the accuracy?
The accuracy is exactly the same in all Aviva devices. The nano uses the same test stripes. The only difference is the size factor and the design.
So why are they running TV ads saying that the Nano and SmartStrips are 23% more accurate ?
When I look at their web site, I cannot find the data to back up this claim. They reference the ISO standard for BG monitors, but this is the same lousy +/- 20% standard they are all tested to. I'd like to see the package insert with the test data, but have not been able to find it online.
oops I meant "smart view" test strips
I called Roche this morning and they informed me that the aviva is 20% more accurate than the standard while the nano is 23% more accurate. Not really a reason to switch. I wish companies would stop working so hard on all the bells and whistles and just focus on getting a more accurate meter out the door. NonInvasive would be really nice.
20% more accurate than the standard? That would mean 100% accurate as the standard is +/-20%. Huh?
I am reading this as a 20% improvement *relative* to the standard.
If the benchmark is +/- 20%, i.e. a reading of 100 could show anything from 80 to 120.
20% better than +/- 20%, would be .2*.2 or 4% better, so , say the actual value of 100 is indicated anywhere from 84 to 116, maybe ?
That's why I'd like to see the actual test data that are usually included on the strips prescribing information stuffed into the package...so we can see what this crazy claim really means.
I'm sure you are reading it correctly, but the statement shouldn't (IMHO) be open to interpretation or misunderstanding. I fail to understand why the science isn't there for better accuracy... but then, I'm not a scientist.
Hoping the G4 dexcom is better, as promised. Hoping for some kind of implanted system with REAL accuracy, some day.
Wow...I just pulled the FDA application for approval from the FDA database. Holger is exactly right
It shows that there are *no changes* between the Aviva Plus and the Nano, other than size, button location, and elimination of coding, and the name. There say in the application there is *no fundamental technology change* and these are the only differences. What bullsh*t!
SPECIAL 510(k): Device Modification
OIVD Review Memorandum (Decision Making Document is Attached)
To: THE FILE RE: DOCUMENT NUMBER k113137
This 510(k) submission contains information/data on modifications made to the SUBMITTER’S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):
The name and 510(k) number of the SUBMITTER’S previously cleared device. Roche ACCU-CHEK Aviva Plus Blood Glucose Monitoring System – k101299
Submitter’s statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user’s and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.
This change was for
A change in physical dimensions from 94 x 53 x 22 mm to 69 x 43 x 20 mm (LxWxH)
A change in ergonomics of user interface (three buttons moved to different locations)
A change from coding via a code key to no coding required
A change to the meter name from “Roche ACCU-CHEK Aviva Plus Blood Glucose Monitoring System” to “Roche ACCU-CHEK Nano SmartView Blood Glucose Monitoring System”
Comparison Information (similarities and differences) to applicant’s legally marketed predicate device including, labeling, intended use and physical characteristics.
A Design Control Activities Summary which includes:
Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis – risk analysis method was FMEA.
Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
A declaration of conformity with design controls. The declaration of conformity should include:
A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.
6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for
Use Enclosure (and Class III Summary for Class III devices).
The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter’s description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.
The device is intended for single patient use only. Super Sani-Cloth Germicidal Disposable Wipe with EPA registration # 9480-4 was validated demonstrating complete inactivation of live virus for use with the meter and lancing device. The sponsor also demonstrated that there was no change in performance or in
the external materials of the meter and lancing device after 260 cleaning and disinfection cycles designed
to simulate 5 years of single-patient use. Labeling was reviewed for adequate instructions for the
validated cleaning and disinfection procedures.
A little more from their application:
"The ACCU-CHEK(& Nano meter was developed to utilize the ACCUDescription
CHEK@ Aviva Plus test system's technology and performance
characteristics. The ACCU-CHEKO Nano meter designers took the
measurement components of the ACCU-CHEK® Aviva Plus system, slightly
changed the firmware and hardware supporting the new user interface and
housing and embedded/programmed the strip lot code information within the
meter so a physical code key or code key port are no longer used.
The ACCU-CHEK® SmartView test strip is a No Code Freedom 2 Chemistry
test strip which shares the same scientific technology as the predicate device,
the ACCU-CHEKOg Aviva Plus test strips. The instrument's measurement
method is not modified as a part of this test strip modification project.
So it sounds like this is a bunch of marketing hoopla with no real change in the meter other than it is a little smaller.
I guess it would save us from needing to put the code in. Strips cost the same
To be fair:
-how should it be possible to improve the accuracy without new test stripes?
-why should a manufacturer offer devices with different internal workings? Would be very expensive because every device needs FDA and worldwide clearance.
-manufacturers normally produce one device with a very conservative design to be present in different markets with different cultures and different cultural codes for design and color. In this case Roche is offering a conservative and a modern design to appeal to different groups in the marketing space. That is at least a choice.
But what I have a problem with is the deceptive advertising they are using (at least in the US). The print and TV ads talk about the "new" SmartView
strips used in the Nano and link it to the "improved accuracy", making it sound like there are new, more accurate strips.
If they simply said we have a new, smaller meter with no coding, it would be clearer.