Thermo Scientific BRAHMS KRYPTOR compact PLUS - Page 52

DEPARTMENT
OF HEALTH
& HUMAN
SERVICES
Public Health
Service
Food and
Drug Administration
2098
Gaither Road
Rockville
MD
20850
Mr.
Jonas
Leichtner
Director
of
Marketing
BR.A.H.M.S
Aktiengelsellschaft
2568A
Riva
Road,
Suite
207
Annapolis,
MD 21401
Re:
K070310
Trade/Device
Name:
BR.A.H.M-S
PCT
sensitive
KRYPTOR®
Test
System
Regulation
Number:
21
CFR 866.3210
Regulation
Name:
Antigen,
Inflammatory
Response
Marker,
Sepsis
Regulatory
Class:
Class
II
Product
Code:
NTM
Dated:
February
20,
2008
Received:
February
20,
2008
Dear
Mr. Leichtner:
We
have reviewed
your Section
5 10(k)
premarket
notification
of intent
to
market
the
device
referenced
above and
have
determined
the
device
is substantially
equivalent
(for
the indications
for use
stated
in the
enclosure)
to
legally
marketed
predicate
devices
marketed
in interstate
commerce
prior to
May 28,
1976,
the enactment
date
of the
Medical
Device
Amendments,
or to
devices
that have
been
reclassified
in accordance
with
the provisions
of the
Federal
Food,
Drug,
and
Cosmetic
Act
(Act)
that do
not require
approval
of a
premarket
approval
application
(PMA).
You
may,
therefore,
market
the
device,
subject
to
the general
controls
provisions
of
the Act.
The
general
controls
provisions
of
the Act
include
requirements
for annual
registration,
listing
of devices,
good
manufacturing
practice,
labeling,
and
prohibitions
against
misbranding
and
adulteration.
If
your device
is
classified
(see
above)
into either
class
II (Special
Controls)
or class
III
(PMA),
it may
be subject
to such
additional
controls.
Existing
major
regulations
affecting
your
device
can
be found
in Title
21,
Code of
Federal
Regulations
(CFR),
Parts
800 to
895. In
addition,
FDA
may
publish
further
announcements
concerning
your
device
in the Federal
Register.
Please
be
advised
that
FDA's
issuance
of a
substantial
equivalence
determination
does
not
mean
that FDA
has
made
a determination
that
your device
complies
with
other
requirements
of the
Act or
any Federal
statutes
and regulations
administered
by other
Federal
agencies.
You
must
comply
with
all the
Act's requirements,
including,
but not
limited
to: registration
and
listing
(21 CFR
Part
807);
labeling
(21
CFR Parts
801
and
809);
and good
manufacturing
practice
requirements
as
set forth
in the
quality
systems
(QS)
regulation
(21
CFR
Part 820).
This
letter will
allow
you to
begin
marketing
your
device
as described
in your
Section
510(k)
premarket
notification.
The FDA
finding
of
substantial
equivalence
of
your