American Association for Clinical Chemistry
Improving healthcare through laboratory medicine
March 2011 Clinical Laboratory News: News from the FDA

News from the FDA

Proposed 510(k) Changes Released

FDA has released its proposed changes to the 510(k) process for clearing medical devices. The 25-point action plan for 2011 includes: streamlining the review process for certain innovative, lower-risk medical devices; clarifying when clinical data should be submitted in a premarket submission; and establishing a new Center Science Council of senior FDA experts to aid in making decisions. The proposed changes are designed to promote device innovation and protect patient safety. See the full list of changes online.

Clearance for Siemens's D-Dimer Test to Exclude Deep Vein Thrombosis

Siemens Healthcare Diagnostics has received FDA clearance for its INNOVANCE D-Dimer blood test to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients where a physician’s pretest probability assessment (PTP) indicates a non-high probability of embolism. The fully automated test operates on the company's Sysmex and BCS family of coagulation systems.

FDA Issues Guidance for MRSA Tests

FDA has created a new list of recommendations for how nucleic acid-based in vitro diagnostic tests for Staphylococcus aureus (SA) should perform and be tested for their analytical and clinical validity. The document was designed to provide industry and agency staff with guidance for tests that detect and differentiate methicillin-resistant Staphylococcus aureus (MRSA) and SA. Such tests are used to prevent and manage infections in healthcare settings. FDA’s guidance document reflects the agency’s current thinking on MRSA tests. The agency stresses that the document should be viewed as recommendations that are suggested, but not required. See the full list of recommendations online.

AdvanDx's Test for Gram-negative Bloodstream Infections Cleared

AdvanDx received FDA clearance for its GNR Traffic Light PNA FISH test. The blood test is the first capable of simultaneously identifying Escherichia coli, Klebsiella pneumonia, and Pseudomonas aeruginosa directly from positive blood cultures containing gram-negative rods in less than 90 minutes.

Nanosphere's Respiratory Virus Subtyping Test Panel Cleared

Nanosphere has received 510(k) clearance from the FDA for its Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) that operates on the Verigene system. The RV+ test detects influenza A and B and respiratory syncytial virus A and B, and further subtypes flu A as H1, H3, or 2009 H1N1.

diaDexus Receives Clearance for New Automated PLAC Test

FDA has granted diaDexus, Inc. clearance to market the new automated version of its proprietary PLAC Test. The diagnostics company, which focuses on the development and commercialization of patent-protected in vitro diagnostic products addressing unmet needs in cardiovascular disease, says the test is based on turbidimetric immunoassay (TIA) technology. The test helps predict a patient’s risk for coronary heart disease and is designed to operate on most clinical chemistry analyzers, greatly increasing the number of clinical labs that are able to offer the PLAC Test.