FDA product code NXX: Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
NXX is the FDA product code for fish (fluorescent in situ hybridization) kit, protein nucleic acid, rna, staphylococcus aureus. It is a Class I device, regulated under 21 CFR 866.3700 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under NXX. The average 510(k) review took 110 days (median 120). FDA has posted 1 recall for NXX devices.
Definition
The s. Aureus pna fish is a qualitative nucleic acid hybridization assay intended for presumptive identification of staphylococcus aureus from blood cultures with gram-positive cocci in clusters (gpcc). This device is not exempt per 21 cfr part 866.9(c)(6).
Classification
| Field | Value |
|---|---|
| Device name | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus |
| Device class | Class I |
| Regulation | 21 CFR 866.3700 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NXX clearance
Top NXX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advandx, Inc. | 4 | 2012-04-03 |
Most recent NXX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K113371 | Advandx, Inc. | STAPHYLOCOCCUS QUICKFISH BC | 2012-04-03 | 139 |
| K092166 | Advandx, Inc. | S. AUREUS/CNS PNA FISH, MODEL KT005 | 2009-11-23 | 125 |
| K091827 | Advandx, Inc. | S. AUREUS PNA FISH | 2009-08-18 | 60 |
| K060099 | Advandx, Inc. | S. AUREUS PNA FISH | 2006-05-08 | 115 |
Recalls for NXX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-07-04.
Frequently asked questions
What is FDA product code NXX?
NXX is the FDA product code for fish (fluorescent in situ hybridization) kit, protein nucleic acid, rna, staphylococcus aureus. It is a Class I device, regulated under 21 CFR 866.3700 and reviewed by the Microbiology panel.
What device class is NXX?
Class I, regulation 21 CFR 866.3700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NXX?
Across 4 cleared submissions the average was 110 days from receipt to decision (median 120).
Which companies have the most NXX clearances?
Advandx, Inc. (4).
Have NXX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-07-04.
Next steps
- Run an FDA pathway report with predicate devices for product code NXX
- Run a recall and safety report across every NXX manufacturer
- Watch product code NXX 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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