Specimen Preparation Systems: Insider Info

Friday, August 15, 2008

A few weeks ago I called the FDA for a little advice. After we talked, the FDA reviewer said, "Tell everyone you can about this; get the word out. It'll help us a lot." I joked and said, "sure, I'll put it on my blog."

JJH Tattoo

At the time I wasn't convinced that a blog was worth the time and effort. After that conversation I could no longer deny that value... so here I am.

The conversation with FDA that day was about sample preparation kits and instruments. I called to find out how FDA categorizes these products and what the labeling should look like.

Specimen preparation kits, when they are not associated with an assay are regulated under 21 CFR Part 862.2310 Clinical Sample Concentrator. They are Class I exempt from 510(k) but are subject to the requirements of the Quality System Regulation (QSR). These types of products include kits to prepare nucleic acids for further testing.

The classification of these products doesn’t change when they are included with higher classification systems. However, if they are part of an application for an assay system, FDA will request software validation data if the system includes an instrument. If you are a manufacturer of one of these devices, you need to register the product. These products fall into the Product Code JJH.

The other part of the discussion with FDA that day was about whether it is required to include either specimen prep reagents as part of the kit or if that wasn’t possible if it’s necessary to list an FDA registered specimen prep kit. The answer to that was a surprising no.

It is necessary to define the quality of the specimen going into the system (purity, concentration, whatever). Once the specifications around specimen quality are defined than it’s necessary to perform studies that demonstrate it’s possible to get to the spec in at least three different ways. That data will be included in either the 510(k) or PMA. The specifications for the incoming specimen will be included in the product insert.

Starting a blog wasn't actually my first idea how to spread the word.  The first thing I offered to do, actually was to get a JJH tatoo.  At the time, that seemed like it might be less painful than starting a blog.  But this is probably more useful.

Tags: 510(k), PMA, QSR, Software Validation, Specimen Prep

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