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Bridgeport,
Connecticut, USA (September
21, 1989)….
Catachem, Inc. (Private) announced today that it has received 510k clearance
from the United States Food and Drug Administration (FDA) for the Bicarbonate (HCO3) in vitro diagnostic chemistry reagent kit. Measurements
of Bicarbonate (HCO3) are primarily used for diagnosing diseases of respiratory
disease, as well as, for monitoring its causes and treatment. The acid-base balance of a solution is called PH. Substances
called buffers keep the pH of the blood from varying over too wide a range.
Bicarbonate (HCO3) is the most important buffer in the blood. It prevents the
blood from becoming too acidic or too alkaline (basic). The blood bicarbonate
level is affected by metabolism and by kidney and lung function. When the body
uses inhaled oxygen to break down food for energy, one of the by-products is
carbon dioxide. Almost all of the carbon dioxide dissolved in the blood is
changed into bicarbonate. This bicarbonate is then carried to the lungs, where
it is changed back into carbon dioxide and exhaled. When there is too much
bicarbonate in the blood (which makes the blood too alkaline), some of the
bicarbonate can be released into the urine by the kidneys. When bicarbonate is
needed to make the blood less acidic, the kidneys reabsorb it from the urine and
put it back into the bloodstream. If a patient hyperventilates, and exhales too
much carbon dioxide, this can result in a low blood bicarbonate level (and high
blood pH). This is called respiratory alkalosis, a condition that may cause
symptoms such as muscle spasms in the hands and feet and a sense of being
suffocated. If a patient does not breathe deeply enough or often enough, one may
develop a high blood bicarbonate level (and low blood pH). This condition is
called respiratory acidosis and can be caused by a reaction to a medication, a
head injury, a chronic lung disease (such as chronic obstructive pulmonary
disease), or fluid buildup in the lungs (pulmonary edema).
A bicarbonate test may be done on a blood sample taken from a vein. It is
often done along with a carbon dioxide test or as part of an arterial blood gas.
For an arterial blood gas study, the blood sample is taken from an artery. 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, Bicarbonate, HCO3,
respiratory disease For
more information contact: Benjamin
Twombly Catachem,
Inc. Ref:
C3106a 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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