[17729591]
Precision systems, inc is advertising a diagnostic chemistry analyzer, the analette ii. This chemistry analyzer is an "open" system, meaning that there should be various reagent manufacturer's to choose from. The manufacturer, precision systems, inc. Is required to perform validation studies on this chemistry analyzer from either their own brand name reagents, or other reagents before the system is market ready. When i called this company to determine what reagent manufacturer's have, they validated on their instrument, they gave me "microgenics"; which is manufactured by thermoscientific. I called thermoscientific and they absolutely do not offer reagents for the analette ii chemistry analyzer. When i called precision systems, inc back and asked them what reagents did they use to validate their instrument, i spoke with (b)(4), he again stated microgenics, and another company that he could not remember the name of. I told him that i spoke with thermoscientific and their reagents were not validated on this instrument. He told me that thermoscientific had their equipment for some years and was doing validation studies, but abruptly stopped. I asked him if he had data verifying the validation for any reagents. He told me he did, and when i asked to see the data, he told me i was not privy to that. I told him i was privy to that as a consumer, and that there were several problems here and that i was going to turn his company into the fda adverse medical device program. First of all, they are selling a diagnostic medical device that has not been validated by any reagent manufacturer, and i as a consumer would not be able to purchase reagents in the united states to perform patient testing on. Second, they were not allowed by clia guidelines, and who knows what other guidelines to sell this instrument unless it is validated, and the statistics were made available to me, the consumer. I cannot validate that it has been fda approved as well. As a medical technologist for over 20 years, and a laboratory consultant for as many years, i cannot tell you how easy it is for my clients to scour the internet and find instruments of this caliber. Most of my clients do not know the important questions to ask, and who knows how many have purchased it to date. It is very scary to see.
Patient Sequence No: 1, Text Type: D, B5