rittyさんは No.1972「predicate??」で書きました。

>現在、製品のラベリングについての翻訳をしているのですが、その中に
>predicate device labellingと出てきます。
>
>predicateといったら、「断定する」、「断言する」、「述部の」という意
>味が辞書にはありますが、predicate device labellingにはどの意味も当
>てはまらないようで、全く検討がつきません。

わかりにくいですが「現行市販基準装置」というような意味のようです:

Do you know what a Predicate Device is?
A 510(k) is a premarketing submission made to FDA to demonstrate
that the device to be marketed is safe and effective, that is,
substantially equivalent (SE), to a legally marketed device that is
not subject to premarket approval(PMA). Applicants must compare
their 510(k) device to one or more similar devices currently on the
U.S. market and make and support their substantial equivalency
claims. A legally marketed device is a device that was legally
marketed prior to May 28, 1976 (preamendments device), or a device
which has been reclassified from Class III to Class II or I, or a
device which has been found to be substantially equivalent to such a
device through the 510(k) process. The legally marketed device(s) to
which equivalence is drawn is known as the predicate device(s). A
claim of substantial equivalence does not mean the device(s) must be
identical. Substantial equivalence is established with respect to:
intended use, design, energy used or delivered, materials,
performance, safety, effectiveness, labeling, biocompatibility,
standards, and other applicable characteristics.
http://www.fda.gov/cdrh/devadvice/31432.html#link_5

Does the in vitro diagnostic device have the same intended use as a
currently marketed device (sometimes referred to as a "predicate
device"),
e.g., glucose test, CPK isoenzyme?
http://www.fda.gov/cdrh/manual/ivdmanul.html

Predicate Device - A legally marketed medical device with the same
intended use as the test being submitted for clearance by a 510(k)
premarket notification. Since the Safe Medical Device Act (SMDA) of
1990, it is no longer required that the first marketing of the
predicate device antedate March 28, 1976.
http://www.fda.gov/cdrh/

Fujiokaさんは No.1973「Re:predicate??」で書きました。
>
>わかりにくいですが「現行市販基準装置」というような意味のようです:

Fujiokaさん、ありがとうございました。非常に助かりました。
そうですよね、FDAのウェブページを検索すればよかったのですね。
確かに現在翻訳している文書は、FDAのものです。

本当にありがとうございました。

Ritty