42 / 136
3. Are the definitions
specified in the SMPR used
and applied appropriately in
the method? If no, please
indicate how the terms are
used.
4. Does the method, as
written, contain all
appropriate precautions and
warnings related to the
method's reagents,
components, instrumentation,
or method steps that may be
hazardous? If no, please
suggest wording or option(s).
1.
Are the definitions
specified in the SMPR used and
applied appropriately in
the
supporting documentation
(manuscripts, method studies,
etc...)? If not, please explain the
differences and if the method is
impacted by the difference.
2. Is there information
demonstrating that the
method meets the SMPR
Method Performance
Requirements using the
Reference Materials stated in
the SMPR? If not, then
specify what is missing and
how this impacts
demonstration of
performance of the method.
3. Is there information
demonstrating that the
method performs within the
SMPR Method Performance
REquirements table
specifications for all analytes
in the SMPR applicability
statement? If not, please
specify what is missing and
whether or not the method's
applicability should be
modified.
1.
Based on the supporting
information, were there any
additional steps in the evaluation of
the method that
indicated the need
for any additional precautionary
statements in the method?
Yes.
No. Need to be added.
Yes.
Yes, but only for selected matrices and even those have not been repeatable in other
samples, for example was applied on cookie type. Will method provide similar results in
other cookies without using separate calibration curve. The method requires separate
calibration curve for different samples even for the matrices for which the method has
been demonstrated to be applicable.
Reference materials are used to calibrate the method but not used to establish
accuracy of the over all method. Other allergen reference materials may be used to
establish accuracy of the method for specified matrices. The method accuracy may be
established further.
Yes but for selected matrices. The method meets SMPR method performance
requirements specifications but those have been demonstrated for selected matrices in
only single sample for the matrix.
No
III. Review of Info in
Support of Method:
IV. General
Submission Package: