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 (July
2, 1985)….
Catachem, Inc. (Private) announced today that it has received 510k clearance
from the United States Food and Drug Administration (FDA) for the Cholesterol
(CH) in vitro diagnostic chemistry reagent kit. Measurements of
Cholesterol (CH) are primarily used for diagnosing atherosclerosis, heart
disease, liver disease and renal disease, as well as for monitoring the causes
and treatment. Cholesterol is a type of fat (called a lipid) that the body uses
to help build cells and produce certain hormones. However, too much cholesterol
in the blood may increase the risk of heart disease, stroke, and coronary artery
disease. When there is too much cholesterol in the blood, it and other
substances may begin to build up along the inside of the artery walls, forming
what is known as plaque. A large deposit of plaque may obstruct the flow of
blood through the artery, affecting blood flow to the heart, brain, or other
vital organs. If unstable plaque tears open, it may trigger the formation of a
blood clot in the artery, which can result in a heart attack or stroke. Cholesterol travels through the blood attached to a protein.
This cholesterol-protein package is called a lipoprotein. A total cholesterol
test measures the total amount of cholesterol in the blood. Lipoprotein analysis
(lipoprotein profile or lipid profile) measures blood levels of total
cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. Some medical
experts recommend routine lipoprotein analysis to screen for lipid disorders,
while others may routinely choose to measure only total cholesterol and HDL
levels. The U.S. Preventive Services Task Force (USPSTF) recommends total
cholesterol and HDL testing for all men age 35 and older and for all women age
45 and older. The USPSTF also recommends routine total cholesterol and HDL
testing for men between the ages of 20 and 35 and for women between the ages of
20 and 45 who have risk factors for heart disease.
All of these tests are done on a sample of blood taken from a vein.
Blood cholesterol, total cholesterol, Cholesterol esters present in the serum sample are hydrolized into free
cholesterol and fatty acids by pancreatic cholesterol esterase (CE). The free
cholesterol formed and in the presence of oxygen, is then oxidized to
cholest-4-en-3-one by cholesterol oxidase (CO) with concomitant production of
hydrogen peroxide. The hydrogen
peroxide produced is quantitatively determined by coupling 4-aminoantipyrine
with p-hydroxybenzoic acid where a quinoneimine dye with maximum absorption at
500 nm is produced. The intensity
of the dye color thus produced is directly proportional to the concentration of
the total cholesterol in the serum sample. CH is a one reagent
liquid chemistry available five sizes. Reagents
are packaged ready-to-use in small glass bottles. Calibrator and controls are
available separately: CH C104-01 6x25 ML, CH C104-02 6x50 ML, CH C102-01 4x500
ML, CH
CL00-01 6x1000 ML, CH CL03-01 1x250 ML. 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™ series,
Olympus™ AU Series™,
RA Series™, Opera™ and 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, Cholesterol, CH, atherosclerosis and heart disease, liver disease, renal disease For
more information contact: Benjamin Twombly Catachem, Inc. Ref: C3021a 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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