|
||
| |||||||
|
Bridgeport,
Connecticut, USA (August 26, 1986)…. Catachem, Inc. (Catachem, Private)
announced today that it has received 510k clearance from the United States Food
and Drug Administration (FDA) for Uric Acid (Uricase, UA)
in vitro diagnostic chemistry reagent kit. Determinations of
Uric Acid (UA) are primarily used for diagnosing leukemia, polycythemia, gout,
renal failure, and psoriasis, as well as, for monitoring the causes and
treatments. Uric acid is a waste
product formed by the breakdown of certain types of amino acids called purines.
Amino acids are the building blocks of proteins. Foods that are high in purines
include liver, kidney, peas and beans (legumes), and some fish. Uric acid is
also produced by the breakdown of the body's cells. Most of the uric acid is eliminated from the body in urine;
the rest passes out of the body in stools. However, if excess uric acid is being
produced or if the kidneys are not able to remove it from the blood normally,
the level of uric acid in the blood increases. High levels of uric acid in the blood can cause the excess
uric acid to be deposited in the body's joints, leading to a form of arthritis
called gout. If gout remains untreated for several years, uric acid crystals can
build up in the joints and surrounding connective tissues, forming hard deposits
called tophi. High levels of uric acid may also lead to kidney failure or result
in the formation of uric acid kidney stones.
This test is done on a blood sample taken from a vein.
UA is determination is made when uricase catalyzes the oxidation of uric acid to
produce allantoin and hydrogen peroxide. The
hydrogen peroxide formed is quantitated by oxidative coupling of
4-aminoantipyrine with 3-5 dichloro-2-hydroxybenzene sulfonic acid (DHBS) in the
presence of peroxidase. The intensity of the color produced is directly
proportional to the concentration of the uric acid in the sample.
The color complex formed is read at 500 nm. UA is a two reagent
chemistry, kits are available in two sizes, reagents are available separately.
Reagents are packaged ready-to-use in small glass bottles. Calibrator and
controls are available separately. UA
Kits: UA Kit C134-01 6x25 ML, UA Kit C134-02 6x50 ML, Reagents: UA R1 C132-01
4x500 ML, UA R2 C132-02 4x100 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, of Uric Acid, UA, leukemia, polycythemia, gout, renal failure, psoriasis For
more information contact: Benjamin Twombly Catachem, Inc. Ref: C3023a 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. |
|
| ||||||||