American Association for Clinical Chemistry
Better health through laboratory medicine
May 2011 Clinical Laboratory News: News from the FDA

News from the FDA


Abbott's Wireless Point-of-Care Testing System Gets Nod

Abbott has received FDA clearance to market its i-STAT 1 Wireless handheld device, a new wireless version of the i-STAT point-of-care testing system that is widely used in hospitals, emergency rooms, and physicians’ offices. The i-STAT 1 Wireless handheld device will enable real-time transmission of diagnostic test results generated by i-STAT 1 directly from the patient’s bedside.

First Test to Help Diagnose Dengue Fever Gets Nod

The first test to help diagnose people with signs and symptoms of dengue fever or dengue hemorrhagic fever has been green lighted for marketing by the FDA. The DENV Detect IgM Capture ELISA test detects antibodies to dengue virus in blood samples from patients who have signs and symptoms of dengue and is manufactured by Inbios, Inc. The test will be available for use in clinical laboratories and will assist in the diagnosis of dengue, which can improve patient care and management.

BD’s HSV Molecular Tests Cleared

BD Diagnostics has received FDA clearance for the first fully automated molecular tests to detect and differentiate Herpes Simplex Viruses types 1 and 2 in clinician-collected external anogenital specimens. The new BD ProbeTec Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays) operate on the BD Viper System with XTR Technology. The system uses strand displacement amplification technology to qualitatively detect and differentiate HSV 1 and HSV 2 DNA.

Test to Detect Toxin B Gene Cleared

FDA has cleared Cepheid’s Xpert C. difficile/Epi test, which is designed to rapidly detect the toxin B gene associated with Clostridium difficile infection (CDI). The Cepheid Xpert C. difficile/Epi assay operates on the Cepheid GeneXpert Dx System. The test helps determine if C. difficile is in a patient’s stool and detects if the C. difficile is the epidemic 027/NAP1/BI strain, which has been associated with an increase in the severity and incidence of CDI in the U.S.

Clearance for Diatron’s Clinical Chemistry System

Diatron Group, a global provider of hematology and clinical chemistry analyzers, has received FDA 510(k) clearance for its clinical chemistry system and will begin commercial operations in the U.S. The company will launch the clinical chemistry analyzer first.