Applying for 510(k) Submission for Blood Glucose Monitor System

[wangyang]

Dear all:

Our company is preparing to submit 510(k) for the blood glucose monitor and the test strips, and when i search FDA's database, i find there are two ways to apply for 510(k), one is to apply for a blood glucose system, which includes the meter, the test strips, the control solutions and the lancet, the other way is to apply for the 510(k) for the meter, and apply for 510(k) for the test strips individually.

What is the difference between the 2 ways of 510(k) submission? Which one is benificary for the manufactuer?

Any response is appreciated.

[Ajit Basrur]

Any answers ?

[Michael Malis]

In Reply to Parent Post by wangyang

Dear all:

Our company is preparing to submit 510(k) for the blood glucose monitor and the test strips, and when i search FDA's database, i find there are two ways to apply for 510(k), one is to apply for a blood glucose system, which includes the meter, the test strips, the control solutions and the lancet, the other way is to apply for the 510(k) for the meter, and apply for 510(k) for the test strips individually.

What is the difference between the 2 ways of 510(k) submission? Which one is benificary for the manufactuer?

Any response is appreciated.

If your company manufacture the complete system (monitor, test strips and control solution) it will be beneficial to submit a 510(k) for the system. This way you can tight this 510(k) around your product...
However, if any of this components are purchased separately then individual 510(k)s are more appropriate.

[wangyang]

I know that when seperate 510(k) is applied for the individual component, the responsibility of the manufactuer will be lightened. This is one of the beneficial point for seperating application. Is there any other beneficial point?

Is there more comprehensive thinking about the 2 kinds of application type?

Thank you.

In Reply to Parent Post by Michael Malis

If your company manufacture the complete system (monitor, test strips and control solution) it will be beneficial to submit a 510(k) for the system. This way you can tight this 510(k) around your product...
However, if any of this components are purchased separately then individual 510(k)s are more appropriate.

[bio_subbu]

In Reply to Parent Post by wangyang

Dear all:

Our company is preparing to submit 510(k) for the blood glucose monitor and the test strips, and when i search FDA's database, i find there are two ways to apply for 510(k), one is to apply for a blood glucose system, which includes the meter, the test strips, the control solutions and the lancet, the other way is to apply for the 510(k) for the meter, and apply for 510(k) for the test strips individually.

What is the difference between the 2 ways of 510(k) submission? Which one is benificary for the manufactuer?

Any response is appreciated.

The difference in the ways of submitting 510(k)s for your device is that one submission is for a system and the other is for stand-alone devices. Base your choice of submission type on how you plan to sell your devices. If you only plan to sell them together as a system, use the 510(k) for a system. If you plan to sell items separately, it is best to apply for separate 510(k)s for the meter, lancet, strips and solutions. In the case of submitting devices as stand-alone devices, you may also be able to do a 510(k) for your devices as a device “family” rather than as a system. That way you can still have all of them in the same 510(k). When bundling devices, you should also consider whether there are one or more predicates. The following guidance documents may be helpful:

1.Bundling Multiple Devices or Multiple Indications in a Single Submission

2.Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology

3.Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems

4.InVitro Diagnostic Glucose Test System

Regards
S. Subramaniam