NIJ · Class II · 21 CFR 866.1640

FDA Product Code NIJ: System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

The In Vitro Device Is Intended To Detect The Presence Of The Vana And Vanb Genes In Isolated Colonies Of Enterococcus Spp. As A Marker For Vancomycin Resistance Using Dna Probe Technology

Leading manufacturers include Cepheid.

6
Total
6
Cleared
149d
Avg days
2002
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 20d recently vs 175d historically

FDA 510(k) Cleared System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species Devices (Product Code NIJ)

6 devices
1–6 of 6
Cleared Nov 21, 2024
Xpert vanA
K243405
Cepheid
Microbiology · 20d

About Product Code NIJ - Regulatory Context

510(k) Submission Activity

6 total 510(k) submissions under product code NIJ since 2002, with 6 receiving FDA clearance (average review time: 149 days).

Submission volume has increased in recent years - 1 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 NIJ have taken an average of 20 days to reach a decision - down from 175 days historically, suggesting improved FDA processing for this classification.

NIJ devices are reviewed by the Microbiology panel. Browse all Microbiology devices →