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Bridgeport,
Connecticut, USA (June 22, 1990)…. Catachem, Inc. (Catachem, Private)
announced today that it has received 510k clearance from the United States Food
and Drug Administration (FDA) for the Total Iron (TFe) in vitro diagnostic chemistry
reagent kit. Measurements of Total
Iron (TFe) activity are primarily used for diagnosing hemolytic anemia, necrotic
hepatitis, pernicious anemia, hemochromatosis, hemosiderosis and lead poisoning,
as well as for monitoring the causes and treatments. Iron
(Fe) is a necessary mineral for the proper function of hemoglobin, the protein
in red blood cells that carries oxygen. It is also needed for proper muscle and
organ function. About three-fourths of the body's iron is bound to hemoglobin in
red blood cells, while the rest is either bound to other proteins (transferrin
in blood or ferritin in bone marrow) or stored in other body tissues. When red
blood cells die, their iron is released and carried by transferrin to the bone
marrow. In the bone marrow, iron is stored and used as needed to make new red
blood cells. Iron studies are usually done to determine: The amount of iron bound to transferrin. This is called the
serum iron measurement. The amount
of iron needed to bind to all of the transferrin in a certain amount of blood.
This value is called the total iron-binding capacity (TIBC) and is an estimate
of the amount of transferrin in the blood. The percentage of sites on
transferrin that have iron bound to them. This is called the amount of
transferrin saturation and equals the serum iron measurement divided by the TIBC.
The original source of all the body's iron is food (such as liver and other
meat, eggs, fish, and leafy green vegetables). Generally, only about 5% to 10%
of the iron in food is actually absorbed, unless the body needs more because of
rapid growth (such as during adolescence), pregnancy, breast-feeding, or at
times when there are low levels of iron in the body (such as after bleeding).
Healthy adult men usually get enough iron from the food they eat. Men have
enough reserves of iron in their bodies to last for several years, even if they
take in no new iron. Therefore, men rarely develop an iron deficiency. Women,
however, can lose large amounts of iron because of menstrual bleeding, during
pregnancy, or while breast-feeding. Therefore, women are more likely than men to
develop an iron deficiency and may need to take an iron supplement. Iron
deficiency in men and women past menopause usually is related to abnormal
bleeding. This test is done on a blood sample taken from a vein.
In
acid buffer, transferrin bound iron dissociates into free ferrous (Fe++)
and ferric (Fe+++) iron. Hydroxylamine hydrochloride present in the same acid reagent reduces the
ferric iron to the ferrous state. The
free ferrous ions react with ferene to form a complex with maximum absorbance at
600nm. The absorbance is directly
proportional to the concentration of total iron. TI is a two reagent chemistry and kits are available in one size, reagents
are available separately. Reagents
are packaged in small glass bottles. Calibrator and controls are available
separately. TFe Kit C284-0A 600 tests, TFe Reagents: TFe R1 C282-01 4x500 ML,
TFe R2a C282-02 5x250 ML, TFe R2b C282-08 12x5 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™, 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, total iron, TI, hemolytic anemia, necrotic hepatitis, pernicious anemia,
hemochromatosis, hemosiderosis, lead
poisoning For
more information contact: Benjamin Twombly Ref: C3033a 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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