Evaluation of Automatic Class III Designation (De Novo) Decision: K121291 added
The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the "De Novo" classification option as an alternate pathway to classify certain new devices that had automatically been placed in Class III due to lack of a predicate.
The De Novo process applies to low and moderate risk devices that have been classified as class III because they were found not substantially equivalent (NSE) to existing devices. Applicants who receive this determination may request a risk-based evaluation for reclassification into class I or II within 30 days of receipt of an NSE determination. Devices that are classified through the De Novo process may be marketed and used as a predicate for future Premarket Notification [510(k)] submissions.
FDA has begun releasing De Novo Summary documents for devices granted market authority through the De Novo process. The De Novo Summary is intended to present an objective and balanced summary of the scientific evidence that served as the basis of the decision to grant a de novo petition. The Summary outlines how FDA determined that the device for which a petition is granted is low to moderate risk and that general and/or special controls provide reasonable assurance of safety and effectiveness. The De Novo Summary also serves as a resource on the types of information necessary to support substantial equivalence for device manufacturers that may wish to use the de novo device as a predicate for future 510(k) submissions.
Links to all available De Novo Summary documents can be found in the table below.
|Device Name||510(k) Number||Approval Letter||Decision Summary|
|Infrascanner Model 1000||K080377||Approval Letter|
|Zeltiq™ Dermal Cooling Device||K080521||Approval Letter|
|Erchonia ML Scanner||K082609||Approval Letter|
|NuMED NuCLEUS and NuCLEUS-X BAV Catheters||K082776||Approval Letter||Decision Summary|
|Hem-Avert Perianal Stabilizer||K083692||Approval Letter|
|RIDASCREEN Norovirus 3rd Generation EIA||K093295||Approval Letter|
|Prostate Mechanical Imager||K093579||Approval Letter||Decision Summary|
|LipiFlow Thermal Pulsation System||K093937||Approval Letter|
|Steris Verify Spore Test Strip for S40||K100049||Approval Letter||Decision Summary|
|InBios DENV Detect IgM Capture ELISA||K100534||Approval Letter||Decision Summary|
|Widex C4-PA Wireless Air-Conduction Hearing Aid||K101699||Approval Letter||Decision Summary|
|Aptus Endovascular Suturing System||K102333||Approval Letter||Decision Summary|
|ImmunoCAP Tryptase||K103039||Approval Letter||Decision Summary|
|Percutaneous Surgical Set with 5 mm or 10 mm Attachments||K110431||Approval Letter||Decision Summary|
|STRATIFY JCV Antibody ELISA||K112394||Approval Letter||Decision Summary|
|Proteus Personal Monitor Including Ingestion Event Marker||K113070||Approval Letter||Decision Summary|
|PORTRAIT TOXIGENIC C. DIFFICILE ASSAY||K113358||Approval Letter||Decision Summary|
|Verigene® Gram Positive Blood Culture Nucleic Acid Test (BC-GP)||K113450||Approval Letter||Decision Summary|
|COBAS INTEGRA 800 Tina-quant HbA1cDx Gen.2 assay||K121291||Approval Letter||Decision Summary|
|xTAG® Gastrointestinal Pathogen Panel (GPP)||K121454||Approval Letter||Decision Summary|
|FerriScan R2-MRI Analysis System||K124065||Approval Letter||Decision Summary|