Thermo Scientific BRAHMS KRYPTOR compact PLUS - 510(k) Summary

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
1 of 6
510(k)
SUMMARYZo
General
Information
MAR
3
1 2008
Submitted
by:
B.R-A.H.M.S
Aktiengesellschafi
Neuendorfstrasse
25
D-
16761
Henningsdorf
near Berlin
Germany
Contact
Person:
Jonas
Leichtner
BR-A.H.M.S
USA, Inc.
2568A
Riva
Road,
Suite
207
Annapolis,
MD 21401
Phone:
(410)
897 9960
Fax:
(410)
972
2452
Email:
i.leichtnera)brahms-usa.com
Date Prepared:
February
14, 2008
Device Name
Trade
Name:
B.R.A.H.M.S
PCT sensitive
KRYPTOR®
Test System
Common
Name:
Inflammatory
Response
Marker
Classification
Name:
Antigen,
Inflammatory
Response
Marker,
Sepsis,
21
CFR
866.3210
Predicate
Device
Manufacturer
Product
Name
510(k)
No.
BR.A.H.M.S
Aktiengesellschaft
B-R.A.H.M.S
PCT
LIA
K040887
Device
Description
The BR.A.H-M-S
PCT
sensitive
KRYPTOR®
assay is
a homogeneous
sandwich
immunoassay
for
detection
of
PCT
in human
serum
or
plasma.
The
B-R.A.H.M.S
KRYPTOR®
analyzer
is a fully
automated
system.
The
B.R.A.H-M'S
KRYPTOR®
analyzer
is
a closed
system
and
can only
operate
utilizing
special
reagents
provided
by
B.R.A-H-M.S
Aktiengesellschaft.
The
measuring
principle
is based
on Time-
Resolved
Amplified
Cryptate
Emission
(TRACE®)
technology,
which
measures
the
signal that
is emitted
from
an
immunocomplex
with
time delay.