FDA Device Clearances

July 31, 2007 — The US Food and Drug Administration (FDA) has granted 510(k) clearance for a fecal occult blood screen test for the detection of colorectal disease and a multifunction analyzer for diagnostic testing. The FDA has also approved a premarket application for a ceramic articulation hip system for primary total hip arthroplasty.

Fecal Occult Blood Screen Test ( ForSure) for Detection of Colorectal Disease

On May 11, the FDA granted 510(k) clearance for a fecal occult blood screen test (ForSure, Aventir Biotech LLC) for the detection of possible colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps in humans. The clearance allows for both over-the-counter and professional applications of the test.

According to the National Cancer Institute, colorectal cancer is ranked third in the United States among the most common cancers and is the third leading cause of cancer-related deaths. Early detection of colorectal cancer improves the chances of successful treatment.

The test is used to identify indicators of human hemoglobin in human stool. The test features a dual-purpose collection tube to serve as a sample applicator and a device to preserve the transportation of patient specimen collection. In addition, the test is stable without the use of dietary restrictions.

Multifunction Analyzer (Trilogy) for Diagnostic Testing

On July 13, the FDA granted 510(k) clearance for a multifunction analyzer (Trilogy) for the testing of serum and urine to aid in the diagnosis and treatment of a variety of diseases.

The device was designed as a blood chemistry analyzer for the quantitative determination of glucose, creatinine, and urea nitrogen in serum. Glucose measurements are used in the diagnosis and treatment of diseases such as diabetes, chronic renal failure, Cushing's disease, pancreatitis, and pancreatic cancer. Creatinine and blood urea nitrogen measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal function.

In addition, the analyzer has an optional ion selective electrodes module for the measurement of sodium and chloride in serum and urine. The measurements of these electrolytes are used in the diagnosis and treatment of diseases involving electrolyte imbalance, such as infection or renal disease.

Ceramic Articulation Hip System (Novation) for Primary Total Hip Arthroplasty

On July 5, the FDA approved a premarket application for a ceramic articulation hip system (Novation, Exactech) for use in primary total hip arthroplasty in skeletally mature patients with a noninflammatory degenerative joint disease that causes pain and/or limited mobility, such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis.

According to the American Academy of Orthopaedic Surgeons, more than 193,000 total hip replacements are performed annually in the United States. The procedure may be recommended by physicians when more conservative treatments, such as exercise, walking aids, medication, or an osteotomy, are not effective.

The hip replacement system is an alumina ceramic artificial hip replacement system that can be surgically implanted to completely replace a diseased or damaged hip joint. Patients using this system are expected to experience a reduction in pain and an improved ability to move.

Cite this: Jill Taylor . FDA Device Clearances: Fecal Occult Blood Screen Test, Multifunction Analyzer, Ceramic Articulation Hip System - Medscape - Jul 31, 2007.

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