March 10, 2010

A Check on Accu-Chek - Fun and Games with FDA Filings

Every month the FDA releases a list of medical devices they have cleared through the Premarket Notification process. This is also known as PMN and 510(k) but what’s in a name anyway?

This often seems little more than a paper game of claiming a device is substantially equivalent to some other device so it should be allowed to be marketed. Looking over these I get the feeling sometimes the documentation may as well read, “Hey we are no worse than that thing!”  That basically is the standard folks, I aint saying it any better but ita aint no worse.

OK maybe I exaggerate. Or maybe not. I have no way of judging the quality of these. The market seem to be saying, "You be the judge."

Accurate or not I don't know but here are some humorous diabetes related 510(k) filings recently released:

The OK Meter:

No pretentions of greatness at all. It is just OK. But wait while merely aspiring to be OK they do manage to hose the user with dual strips. 

I can just see the sales material. Our meter is ordinary, just… well… OK. But that not all with TWO strips you are twice as ordinary!
DEVICE: OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM
http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090609.pdf


As long as you can see - listen to this, “This meter has some speaking functions but is not intended for use by the visually impaired.”
DEVICE: MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS
http://www.accessdata.fda.gov/cdrh_docs/pdf9/K093635.pdf
Not to be confused with ezManager Max, there is the EasyMax meter.
DEVICE: EASYMAX V  SELF MONITORING BLOOD GLUCOSE SYSTEM
http://www.accessdata.fda.gov/cdrh_docs/pdf9/K092894.pdf

Want to test you blood and you blood pressure with the same device. We got it baby. (Does the BP meter squeezing the arm make it easier or harder to get blood out of your finger?)
DEVICE: ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
http://www.accessdata.fda.gov/cdrh_docs/pdf9/K093592.pdf

I have saved the best for last – from the Home Head Office Bureau of Backup Redundancy Department, located on Street Road, this is my favorite bit of dual double speak.

They named their product to sound like someone else, claim substantial equivalence to that other product based on the “same working principle” and then point out the test principal is a difference. 

http://www.accessdata.fda.gov/cdrh_docs/pdf8/K082965.pdf
They say:
A claim of substantial equivalence is made to ACCU-CHIEK Aviva System
(k043474). Both of them have the same working principle and technologies.


Followed by: 



That all seems like silly fun and games but what if some kindly but some what befuddled by alliteration type comes along and confuses their A-Check for an Accu-Chek and puts the wrong strips in their meter?

Not so much fun. Come to think of it I would be pissed if I were easily confused. Oh wait I am.

1 comment:

  1. The EasyMax meter is just OK. Now I've said my peace.

    ReplyDelete