FDA Device Clearances: Whole Blood Test, Herpes Simplex Virus Test, Cervical Plate System

Jill Taylor

November 06, 2007

November 6, 2007 — The US Food and Drug Administration (FDA) has granted 510(k) clearance for a whole blood test to aid in the diagnosis of medical conditions such as infection, inflammation, bone marrow failure, autoimmune diseases, drug toxicity, and leukemic neoplasia; a herpes simplex type 2 test to aid in the diagnosis of herpes simplex type 2; and a cervical plate system for anterior screw fixation at the C2 through C7 vertebral bodies of the cervical spine.

Whole Blood Test ( HemoCue White Blood Cell Analyzer) for Diagnostic Purposes

On November 1, Quest Diagnostics Incorporated announced that the FDA granted 510(k) clearance for a whole blood test ( HemoCue White Blood Cell Analyzer) to aid in the diagnosis of numerous medical conditions such as infection, inflammation, bone marrow failure, autoimmune diseases, drug toxicity, and leukemic neoplasia.

Changes in white blood cell counts are used by physicians to detect a range of conditions and disorders. Using finger-stick blood samples, the new device produces quantitative results of a patient's white blood cells that have traditionally been provided by reference laboratories. These results are provided in as few as 3 minutes.

The analyzer is a product of HemoCue AB, a Quest Diagnostics company. According to a statement by Quest Diagnostics, HemoCue plans to apply for CLIA waiver for the device, which would permit physicians to offer the test in CLIA-waived laboratories.

Herpes Simplex Virus Type 2 Test ( HerpeSelectExpress HSV-2) for Diagnostic Purposes

On September 24, the FDA granted 510(k) clearance a herpes simplex virus type 2 test ( HerpeSelectExpress HSV-2, Focus Diagnostics, Inc) to aid in the diagnosis of herpes simplex type 2 virus, the most common cause of genital herpes.

Genital herpes is a sexually transmitted disease that is estimated to affect at least 45 million people in the United States alone. Active infections typically appear in the genital or rectal areas as blisters, which result in ulcers that may take weeks to heal. However, people can carry the virus without experiencing outbreaks and may expose others to the risk of infection without realizing it.

The new test is designed for use in point-of-care settings and can produce results within 15 minutes.

The test is a product of Focus Diagnostics, Inc, a wholly owned subsidiary of Quest Diagnostics Incorporated. According to a statement by Quest Diagnostics, Focus Diagnostics plans to apply for CLIA waiver for the test, which would permit physicians to offer it in CLIA-waived laboratories.

Cervical Plate System ( Valeo Cervical Plate System) for Cervical Spine Fixation

On October 29, the FDA granted 510(k) clearance for a cervical plate system ( Valeo Cervical Plate System, Amedica Corporation) for the stabilization of the cervical spine by anterior screw fixation at the C2 through C7 vertebral bodies.

The Valeo Cervical Plate System is designed to achieve a consistent supplemental fixation outcome, with features such as variable screw angulations, single-step screw insertion, and a narrow plate holder with integrated variable or fixed angle drill guides.

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