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Bridgeport,
Connecticut, USA (May 24, 1990)…. Catachem, Inc. (Private) announced today
that it has received 510k clearance from the United States Food and Drug
Administration (FDA) for the Amylase (AMY) in vitro diagnostic chemistry
reagent. Measurements of
Amylase activity (AMY) are primarily used for diagnosing diseases of the
pancreas, as well as, for monitoring its causes and treatment. AMY is an enzyme that changes complex sugars (starches) into
simple sugars that can be used by the body. It is produced by the pancreas and
salivary glands and released into the mouth, stomach, and intestines. Normally,
only low levels of amylase are found in the blood or urine. However, if the
pancreas or salivary glands become damaged or blocked, more amylase is usually
released into the blood and urine. In the blood, amylase levels rise for only a
short time. In the urine, levels may remain high for several days.
A test for lipase, another enzyme produced by the pancreas (but not by
the salivary glands), is often done at the same time as the test for amylase
(see Lipase test). Measuring both amylase and lipase can sometimes help
determine the cause of a high amylase level in the blood.
This test is done on a sample of blood from a vein or on a sample of
urine collected over 2 or 24 hours. A-amylase hydrolyzes the 2-chloro-p-nitrophenyl-a-D-maltotrioside (CNP-G3)
to release 2-chloro-p-nitrophenol and form 2-chloro-p-nitrophenyl-a-D-maltoside
(CNPG2), maltotriose (G3) and glucose (G).
The rate of formation of the 2-chloro-p-nitrophenol can be detected
spectrophotometrically at 405 nm to give a measurement of a-amylase activity in
the sample. AMY is a one reagent chemistry available in four sizes. Reagents are
packaged ready-to-use in small glass bottles. Calibrator and controls are
available separately. AMY Kit C334-01 6x25 ML, AMY Kit C334-02 1x250 ML, AMY Kit
C332-01 1x250 ML, AMY Kit C332-02 5x250 ML. About
Catachem, Inc. Founded
in 1984 Catachem has a rich 20 year history in clinical chemistry as a manufacturer and distributor of in-vitro chemistry products and services
for assays in 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 diagnostic and veterinary
diagnostic 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, Amylase, AMY, pancreas For
more information contact: Benjamin Twombly Catachem, Inc. 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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