FDA product code NXD: Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
NXD is the FDA product code for nucleic acid amplification, novel influenza a virus, a/h5 (asian lineage) rna. It is a Class II device, regulated under 21 CFR 866.3332 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under NXD, from 2 different applicants. The average 510(k) review took 186 days (median 186). 1 De Novo request was granted under it.
Definition
Novel influenza a virus reagents are used in nucleic acid amplification tests to directly detect and differentiate novel influenza a virus specific rna gene segments in human respiratory specimens or viral cultures. Detection and differentiation of specific rna gene segments aids in the diagnosis of influenza caused by novel influenza a viruses in patients with clinical and epidemiological risk of infection with these viruses. They also aid in the presumptive identification of specific novel influenza a viruses and provide epidemiological information on influenza. These reagents are primers and probes, along with a specific novel influenza virus control.
Classification
| Field | Value |
|---|---|
| Device name | Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna |
| Device class | Class II |
| Regulation | 21 CFR 866.3332 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NXD clearance
Top NXD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| U.S. Army Medical Material Development Command | 1 | 2010-07-06 |
| Centers for Disease Control and Prevention | 1 | 2008-09-30 |
Most recent NXD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K100287 | U.S. Army Medical Material Development Command | JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136 | 2010-07-06 | 158 |
| K080570 | Centers for Disease Control and Prevention | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL | 2008-09-30 | 214 |
Recalls for NXD devices
openFDA lists no recalls for product code NXD.
Frequently asked questions
What is FDA product code NXD?
NXD is the FDA product code for nucleic acid amplification, novel influenza a virus, a/h5 (asian lineage) rna. It is a Class II device, regulated under 21 CFR 866.3332 and reviewed by the Microbiology panel.
What device class is NXD?
Class II, regulation 21 CFR 866.3332. Typical premarket route: 510(k).
How long does a 510(k) take for product code NXD?
Across 2 cleared submissions the average was 186 days from receipt to decision (median 186).
Which companies have the most NXD clearances?
U.S. Army Medical Material Development Command (1); Centers for Disease Control and Prevention (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NXD
- Run a recall and safety report across every NXD manufacturer
- Watch product code NXD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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