FDA Product Code NPR: Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
The Factor II G20210A mutation increases the risk of venous thromboembolism. FDA product code NPR covers in vitro diagnostic tests for the detection of Factor II G20210A mutations by genomic DNA PCR.
These molecular assays identify the prothrombin gene mutation associated with elevated plasma prothrombin levels and increased thrombotic risk, informing anticoagulation decisions in patients with VTE or family history of clotting disorders.
NPR devices are Class II medical devices, regulated under 21 CFR 864.7280 and reviewed by the FDA Pathology panel.
Leading manufacturers include Cepheid and Roche Molecular Systems, Inc..
FDA 510(k) Cleared Test, Factor Ii G20210a Mutations, Genomic Dna Pcr Devices (Product Code NPR)
About Product Code NPR - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code NPR since 2003, with 5 receiving FDA clearance (average review time: 146 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under NPR have taken an average of 28 days to reach a decision - down from 175 days historically, suggesting improved FDA processing for this classification.
NPR devices are reviewed by the Hematology panel. Browse all Hematology devices →