FDA Device Clearances
FDA Device Clearances
January 8, 2007 — The US Food and Drug Administration (FDA) has granted 510(k) clearance for a test for the rapid detection of methicillin-resistant Staphylococcus aureus, a test for the detection of respiratory viruses, and an ultrasound system for ophthalmic use.
Rapid Test (BD GeneOhm StaphSR Assay) for Detection of Methicillin-Resistant Staphylococcus Aureus
On December 21, the FDA granted 510(k) clearance for a test (BD GeneOhm StaphSR Assay, BD Diagnostics) for the rapid detection of methicillin-resistant Staphylococcus aureus (MRSA).
MRSA is a mutant strain of Staphylococcus bacterium that does not respond to methicillin, an antibiotic that has historically been effective against staph infections. Once acquired primarily in hospitals and long-term care facilities, MRSA infections have become increasingly more common in the community. MRSA is responsible for a variety of skin and soft-tissue infections, as well as a serious form of pneumonia, and can be life-threatening.
The new assay uses molecular methods to differentiate between MRSA bacterium and the more common, less dangerous staph bacterium that is still responsive methicillin treatment. The test is performed with blood samples and yields results in 2 hours.
Test (xTAG Respiratory Viral Panel) for Detection of Respiratory Viruses
On January 3, the FDA granted 510(k) clearance for a test (xTAG Respiratory Viral Panel, Luminex Molecular Diagnostics) for the detection of 12 viruses that cause infectious respiratory disease.
The xTAG Respiratory Viral Panel is the first test for influenza A subtypes H1 and H3, as well as for the recently identified human metapneumovirus. Other viruses detected by the test include influenza B, respiratory syncytial virus (A and B), parainfluenza (1, 2, and 3), rhinovirus, and adenovirus.
Using a multiplex platform, the panel allows several tests to be processed for each sample. The test amplifies viral genetic material in samples of secretions collected from the back of the throat and then identifies the specific virus by sorting microspheres that bind to the amplified genetic material.
Ultrasound (MASTER-VU B-Scan System) for Ophthalmic Use
On December 19, the FDA granted 510(k) clearance for an ultrasound system (MASTER-VU B-Scan System, Sonomed, Inc) for ophthalmic use.
The MASTER-VU System is portable, consisting of a B-scan probe that can be interfaced by USB cable connection to a standard personal computer with Sonomed's proprietary software installed. Features include on-screen annotation (using both text and graphics), adjustable near-mid-far gains, horizontal and vertical scales, the ability to save thumbnail and video clips, and a multiple caliper tool for intraocular distance measurements.
January 8, 2007 — The US Food and Drug Administration (FDA) has granted 510(k) clearance for a test for the rapid detection of methicillin-resistant Staphylococcus aureus, a test for the detection of respiratory viruses, and an ultrasound system for ophthalmic use.
Rapid Test (BD GeneOhm StaphSR Assay) for Detection of Methicillin-Resistant Staphylococcus Aureus
On December 21, the FDA granted 510(k) clearance for a test (BD GeneOhm StaphSR Assay, BD Diagnostics) for the rapid detection of methicillin-resistant Staphylococcus aureus (MRSA).
MRSA is a mutant strain of Staphylococcus bacterium that does not respond to methicillin, an antibiotic that has historically been effective against staph infections. Once acquired primarily in hospitals and long-term care facilities, MRSA infections have become increasingly more common in the community. MRSA is responsible for a variety of skin and soft-tissue infections, as well as a serious form of pneumonia, and can be life-threatening.
The new assay uses molecular methods to differentiate between MRSA bacterium and the more common, less dangerous staph bacterium that is still responsive methicillin treatment. The test is performed with blood samples and yields results in 2 hours.
Test (xTAG Respiratory Viral Panel) for Detection of Respiratory Viruses
On January 3, the FDA granted 510(k) clearance for a test (xTAG Respiratory Viral Panel, Luminex Molecular Diagnostics) for the detection of 12 viruses that cause infectious respiratory disease.
The xTAG Respiratory Viral Panel is the first test for influenza A subtypes H1 and H3, as well as for the recently identified human metapneumovirus. Other viruses detected by the test include influenza B, respiratory syncytial virus (A and B), parainfluenza (1, 2, and 3), rhinovirus, and adenovirus.
Using a multiplex platform, the panel allows several tests to be processed for each sample. The test amplifies viral genetic material in samples of secretions collected from the back of the throat and then identifies the specific virus by sorting microspheres that bind to the amplified genetic material.
Ultrasound (MASTER-VU B-Scan System) for Ophthalmic Use
On December 19, the FDA granted 510(k) clearance for an ultrasound system (MASTER-VU B-Scan System, Sonomed, Inc) for ophthalmic use.
The MASTER-VU System is portable, consisting of a B-scan probe that can be interfaced by USB cable connection to a standard personal computer with Sonomed's proprietary software installed. Features include on-screen annotation (using both text and graphics), adjustable near-mid-far gains, horizontal and vertical scales, the ability to save thumbnail and video clips, and a multiple caliper tool for intraocular distance measurements.
