DPC Receives FDA Clearance to Market IMMULITE

DPC Receives FDA Clearance to Market IMMULITE® 2000 Allergen-Specific IgE as Third-Generation Assay
Diagnostic Products Corporation (DPC) has been granted FDA 510(k) clearance to market IMMULITE^® 2000 Allergen-Specific IgE as a third-generation assay. The assay, which has been renamed IMMULITE 2000 Third Generation Allergen-Specific IgE, has been validated according to the NCCLS I/LA20-A guidelines. It offers a 0.1 kU/L detection limit, which is 3.5 times lower than any other allergen-specific IgE assays, and a functional sensitivity of 0.2 kU/L. It also exhibits linearity under dilution down to 0.1 kU/L. In addition to its accuracy and precision, IMMULITE 2000 Third Generation Allergen-Specific IgE offers full random access automation, a large menu of allergens and panels, high throughput, fast turnaround, and the ability to run allergy assays alongside any IMMULITE 2000 immunoassay DPC offers.

With the added advantage of immunoassay platform consolidation, IMMULITE 2000 Third Generation Allergen-Specific IgE has made allergy testing a viable business for even small laboratories. The IMMULITE test menu includes more than 100 assays and 270 different specific allergens and allergy panels.