FDA Product Code NQX: System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
A Nucleic Acid Amplification Assay System (including Probes, Other Reagents, And Instrumentation) Is An Aid In The Identification Of Mrsa Colonization Status For The Prevention And Control Of Mrsa Infections In Healthcare Settings.
Leading manufacturers include Cepheid.
FDA 510(k) Cleared System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen Devices (Product Code NQX)
About Product Code NQX - Regulatory Context
510(k) Submission Activity
24 total 510(k) submissions under product code NQX since 2004, with 24 receiving FDA clearance (average review time: 111 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under NQX have taken an average of 26 days to reach a decision - down from 119 days historically, suggesting improved FDA processing for this classification.
NQX devices are reviewed by the Microbiology panel. Browse all Microbiology devices →