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Update June 7, 2007
Guidance for Industry and FDA Staff - Assayed and Unassayed Quality
Control Material
Document issued on: June 7, 2007
The draft of this guidance was issued on February 3, 1999
Purpose:
This guidance document provides recommendations to manufacturers
regarding preparation of premarket notifications and labeling for
quality control (QC) material. These materials are intended to monitor
reliability of a test system and help minimize reporting of incorrect
test results.
What it clearly does and does not address:
This guidance addresses external QC material. It is not intended to
address internal controls, process controls (such as control lines on
single use devices) or, electronic QC. This guidance does not address
calibrators. This guidance also does not address QC materials for
genetic tests for heritable diseases or pharmacogenetic testing. This
guidance also is not intended to apply to QC materials for use with
donor screening tests.
Particulars:
The guidance describes the distinctions of Assayed and Unassayed QC
Material for Qualitative and Quantitative Assays. Both types of QC
materials are subject to the Quality System Regulation (QSR), 21 CFR,
Part 820, and labeling regulation 21 CFR 809.10. The guidance notes that
most types of unassayed QC materials are exempt from premarket
notification. Although premarket notifications are not required for
unassayed QC materials, some aspects of this guidance such as labeling,
stability, and matrix effects are still relevant for these materials.
When QC materials are included as a component of a test system that is
itself exempt from premarket notification, the QC materials also do not
need premarket notification. However, as with unassayed QC materials,
many of the recommendations in this guidance document for evaluation and
labeling still apply.
It provides clearly defined information to include in a 510(k) for
Assayed QC Materials. It evaluates performance and results of matrix
effects, analytic value assignment, stability processes, and “surrogate”
QC material. The guidance also gives an overview of the labeling
processes of intended use, reagents, operating instructions, warnings,
assigned target values and ranges, frequency of QC, performance
characteristics, and limitations.
For further detailed information on the guidance please visit FDA
website:
http://www.fda.gov/cdrh/oivd/guidance/2231.html
or contact mdi at
info@mdiconsultants.com
If you have
comments regarding this update, please contact Romil Rambhia at
516-482-9001 or email at
romil@mdiconsultants.com |
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