Friday December 05 2008 | Biotechnology feed | All feeds
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Friday December 05 2008 | Biotechnology feed | All feeds
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Bridgeport,
Connecticut, USA (October
16, 1989)….
Catachem, Inc. (Catachem, Private) announced today that it has received 510k
clearance from the United States Food and Drug Administration (FDA) for the Creatine Kinase (creatine phosphokinase, CPK,
CK) in vitro diagnostic chemistry reagent kit. Measurements of
Creatine Kinase (CK) activity are primarily used for diagnosing skeletal muscle
disease, myocardial infarction, cerebrovascular accidents, muscular dystrophy,
hypothyroidism, pulmonary infarctions, as well as for monitoring the causes and
treatments. During a heart attack
(or myocardial infarction), damaged heart tissue releases specific proteins
called cardiac enzymes. One way to diagnose or confirm a recent heart attack is
to test a person's blood for increased levels of these enzymes.
The main enzymes that are measured are troponin I, creatine phosphokinase
(CPK, CK), and lactate dehydrogenase (lactic acid dehydrogenase, LDH). Low
levels of these enzymes are normally found in your bloodstream, but if your
heart muscle is injured (as in a heart attack), the enzymes leak out of damaged
heart muscle cells and their levels in the blood rise. CPK is found in the heart
muscle, liver, skeletal muscles (such as in the arms and legs), and in the
brain. LDH is found in many other body tissues, including the liver, kidneys,
skeletal muscles, the brain, and lungs. CPK-MB is a subtype of CPK that is found
only in heart muscle. LDH-1 is a subtype of LDH that is found mainly in red
blood cells and in heart muscle. Some of these enzymes are also found in other
parts of the body besides heart muscle, and their levels in the blood may rise
when those other tissues are damaged. However, troponin I is released only by
heart muscle. Cardiac enzyme studies must always be interpreted in light of your
symptoms, your physical exam findings, and electrocardiography (EKG) results. All of these tests are done on a sample of blood taken from a
vein. Creatine kinase enzymne catalyzes the conversion of creatine phosphate and
adenosine diphosphate to creatine and ATP.
The resultant ATP is quantitatively determined by coupling a hexokinase
(HK) reaction and a glucose-6-phosphate dehydrogenase (GPDH) reaction to the CK
reaction. GPDH catalyzes the
oxidation of glucose-6-phosphate to 6-phosphogluconic acid with concomittant
reduction of NADP. The amount of
NADPH produced is proportional to the CK activity present in the serum sample
and its concentration is measured by the increase in absorbance at 340 nm. CK is a one reagent chemistry and kits are available in three sizes and
reagents are available separately. Reagents
are packaged in small glass bottles. Calibrator and controls are available
separately. CK Kits: CK Kit C184-0A 600 tests, CK Kit C184-0B 1200 tests, CK Kit
C182-0A 2500 tests, CK Reagents: CK R1a C182-03 5x250 ML, CK R1b C182-04 8x5.8
g. About
Catachem, Inc. Catachem
has a rich 20 year history in clinical chemistry as a manufacturer and
distributor of in-vitro chemistry products and services for human, veterinary
and environmental laboratories. Catachem chemists helped develop many of the
automated diagnostic chemistries widely in use today. Catachem created the DiscretePak™
and VetSpec™ line of reagents
for human and veterinary automated analyzers.
Catachem offers FDA approved (510K) chemistries (liquid and dry)
including enzymatic chemistries developed in conjunction with IFCC and CDC.
Catachem has more than 500 applications for all types of analyzers
including the Roche™, Hitachi™, Olympus™,
AU Series™, RA Series™, Opera™,
DAX™, Bayer™, Advia™,
Synchron™, Beckman™, Abbott™
and many other analyzers. Corporate
headquarters, research, custom formulation laboratories, and manufacturing are
located in Bridgeport, Connecticut. Catachem
supplies leading laboratories and equipment manufacturers from distributors
around the world. Forward-looking
statements in this release are made pursuant to the ``safe harbor'' provision of
the Private Securities
Litigation Reform Act of 1995. Investors are cautioned that such forward-looking
statements involve risks and uncertainties including, but not limited to, the
results of research and development efforts, the effect of regulation by the
United States Food and Drug Administration and other agencies, the impact of
competitive products, product development commercialization and
technological difficulties, and other risks detailed in the Company's
periodic reports filed with the Securities and Exchange Commission. Keywords:
Catachem, Chemistry, Reagents, In-Vitro Diagnostics, IVD, Creatine Kinase, CK, Creatine
phosphokinase,
CK, skeletal muscle disease, myocardial infarction, cerebrovascular
accidents, muscular dystrophy, hypothyroidism, pulmonary infarctions For
more information contact: Benjamin Twombly Ref: C3032a Catachem
chemistries include: 5'-Nucleotidase (5NT), Adenosine Deaminase (ADA), Alanine
Aminotransferase (ALT), Albumin BCG (ALB), a-L-Fucosidase (AFU), Alkaline
Phosphatase (ALP), Ammonia (NH), Amylase (AMY), Aspartate Aminotransferase
(ALP), β-Hydroxybutyrate (BHBA), Bicarbonate (HC03), Bile Acids (BA),
Bilirubin, Direct with Blank (DBILI), Bilirubin, Total with Blank (TBILI),
Bilirubin, Total (TBILI), Blood Urea Nitrogen (BUN), Bromide (BR), CO2 [340]
(CO2), CO2 [380] (CO2), CO2 [single reagent] (CO2), Ca+++ Arsenazo [650NM]
(CA3), Chloride [340 NM] (CL), Cholesterol (CH), Creatine Kinase (CK),
Creatinine (CREAT), Fructosamine [millimole method] (FR), Fructosamine, Glycated
Serum Protein [enzymatic] (FR), Gamma-Glutamyl Transpeptidase (GGT), Glucose
Hexokinase (GLU), Glycated Hemoglobin (HbA1c), High Density Lipoproteins,
Dextran Sulfate (HDL), Inorganic Phosphorus (IP), Lactate Dehydrogenase (LD),
Lipase (LIP), Lithium [enzymatic] (LI), Magnesium (MG), N-Acetyl-ß-D-glucosaminidase
(NAG), Potassium [enzymatic] (K), Plasma Free Hemoglobin (PFH), Pre-albumin (TBPA),
Sodium [enzymatic] (NA), Sorbitol Dehydrogenase (SDH), Thiopurine
methyltransferase (TPMT), Total Bile Acids (TBA), Total Iron (TI), Total Protein
(TP), Triglycerides (TRIG), UIBC and TIBC (UIBC), Uric Acid (UA), Vitamin B6
(V6B), Multipoint Calibrator Catacal, Catatrol Level 1 Catatrol Level 2, Bile
Acids Control, Bile Acids Calibrator, BHBA Calibrator, BHBA Control Level 1,
BHBA Control Level 2; Bromide Calibrator, BR Control Level 1, BR Control Level
2; Fructosamine Calibrator, FR Control Level 1, FR Control Level 2, SDH Control
Level 1, SDH Control Level 2. Call
+1 (203) 335-9277 or Write Catachem@aol.com. |
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