Contact Information: For Further Information Contact: Diazyme Laboratories: Sales and Marketing Jeff Davis (858) 455-4491 Email Contact Public Relations: Doug Fouquet (858) 455-2173 Email Contact
Diazyme Receives FDA 510(k) Clearance for Low Cost Enzymatic Assay
| Source: General Atomics
SAN DIEGO, CA -- (MARKET WIRE) -- May 3, 2007 -- Diazyme Laboratories announced today that the
U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k)
clearance to market its Enzymatic Creatinine Assay Kit for the quantitative
determination of creatinine in serum and urine samples. The Diazyme method
is a liquid stable, two reagent system which uses coupled enzyme reactions
which are more specific and sensitive than conventional non-enzymatic
methods.
The assay features a reduced sample size requirement which is ideal for
neonatal testing with specimen requirements as low as 4-8 µL per test. The
method also provides an improved interference profile with no significant
interferences from bilirubin to 16 mg/dl, hemoglobin to 200 mg/dl,
triglycerides to 1000 mg/dl and ascorbic acid to 50 mg/dl. Compared to the
colorimetric Jaffe methods for creatinine which are caustic (picric acid)
and can stain analyzer tubing and cuvette, the Jaffe method gives a 20%
false elevation of creatinine at the low creatinine concentration range.
Diazyme enzymatic method is non-caustic, non-staining and has no costly
hazardous shipping requirements. Instrument parameters are available for a
wide array of analyzers with a choice of packaging formats suitable for use
in laboratories of all volumes and workflows.
Diazyme Laboratories is a division of General Atomics headquartered in La
Jolla, California. Diazyme uses its platform enzyme technologies including
enzyme cycling, Substrate-Trapping-Enzyme (STE), and Allosteric Enzyme
Coupled Immunoassay (AECIA), to develop low cost and uniform diagnostic
products for clinical and research use. Products include diagnostic blood
tests for liver disease, cardiac markers, diabetes, renal disease and
electrolytes. Diazyme's enzyme technology and related products can be
found in its website at www.diazyme.com.