Thermo Scientific BRAHMS KRYPTOR compact PLUS - Page 48

B'R'A'H'M'S
Aktiengesellschaft
510(k)
Premarket
Notification
B.R.A.H'M'S
PCT
sensitive KRYPTOR®
Test System
Section
5.0, 510(k)
Summary
Page 3
of 6
Intended
Use
The
B.R-A'H'M'S
PCT sensitive
KRYPTOR®
is an
immunofluorescent
assay
used
to
determine
the concentration
of
PCT (procalcitonin)
in human
serum
and
plasma.
The
B.R.A.H.M.S
PCT
sensitive
KRYPTOR®
is intended
for
use in
conjunction
with
other
laboratory
findings
and clinical
assessments
to aid
in the
risk assessment
of
critically
ill
patients
on their
first
day of
ICU admission
for progression
to severe
sepsis
and septic
shock.
Technological
Comparison
The B.R.A.H-M.S
PCT sensitive
KRYPTOR®
and the
B.R.A.H.M.S
PCT LIA
have
similar indications
for
use, are quantitative
assays,
and
are used to
determine
the
concentration
of PCT
in human
serum
and plasma
The
devices
utilize
different
technologies
and
instruments
to obtain
the
results.
TRACE®
technology
(immunofluorescence)
is used
with the B.R.A.H-M-S
KRYPTOR®
analyzer
and
chemiluminescence
is
used with
a luminometer
for BRA-H'M'S
PCT
LIA.
Each
device
uses 2
antibodies,
one
of which
is the same
for
both devices.
The
monoclonal
antibody used
in both
devices binds
to Katacalcin.
For
the second
antibody,
the
B-R'A'H'M'S
PCT sensitive
KRYPTOR®
uses
a polyclonal
antibody,
which
is
directed
against
Calcitonin.
The B.R.A-H-M.S
PCT LIA uses
a monoclonal
antibody
directed
against Calcitonin
instead
of a polyclonal
antibody.
Although
the antibodies
directed
against
Calcitonin
come
from different
origin
they
bind to
the same
epitopes.
Therefore
they will bind
to the
same PCT
molecule.
Performance
Summary
Precision
and Reproducibility
Based
on CLSI testing,
the analytical
sensitivity
was determined
to
be 0.02 ng/ml
and
the functional
assay sensitivity
(FAS)
was determined
to be
0.06 ng/ml.
In addition,
the
total precision
ranges from
3.2 - 13.4
% CV and
the within
run precision
ranges
from 1.0
- 13.6 % CV.
High
Dose Hook Effect
The
B.R.AoH.M.S
PCT
sensitive KRYPTOR®
assay is homogenous,
and does not
require
separation
or washing
steps. It is
thus possible
to obtain
data without
interrupting
the
immunological
reaction.
High concentration
samples (> 50
ng/ml) are
detected
in the first
few seconds
of
incubation
and may
be diluted
by
the appropriate
dilution factor,
then
re-assayed
automatically.
This process
allows
for sample
measurements
greater
than
50 ng/ml
up to 5000
ng/ml.