FDA product code NTW: System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
NTW is the FDA product code for system, blood collection, rna stabilization, rna purification, rt-pcr molecular diagnostic test. It is a Class II device, regulated under 21 CFR 866.4070 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under NTW. The average 510(k) review took 189 days (median 189). 1 De Novo request was granted under it. FDA has posted 1 recall for NTW devices.
Definition
System for collection, storage, and transport of whole blood and stabilization of intracellular rna with subsequent isolation and purification of host rna for rt-pcr used in molecular diagnostic testing
Classification
| Field | Value |
|---|---|
| Device name | System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test |
| Device class | Class II |
| Regulation | 21 CFR 866.4070 |
| Review panel | PA — Pathology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NTW clearance
Top NTW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Preanalytix GmbH | 1 | 2009-02-04 |
Most recent NTW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K082150 | Preanalytix GmbH | MODIFICATION TO PAXGENE BLOOD RNA SYSTEM | 2009-02-04 | 189 |
Recalls for NTW devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-05-06.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code NTW?
NTW is the FDA product code for system, blood collection, rna stabilization, rna purification, rt-pcr molecular diagnostic test. It is a Class II device, regulated under 21 CFR 866.4070 and reviewed by the Pathology panel.
What device class is NTW?
Class II, regulation 21 CFR 866.4070. Typical premarket route: 510(k).
How long does a 510(k) take for product code NTW?
Across 1 cleared submissions the average was 189 days from receipt to decision (median 189).
Which companies have the most NTW clearances?
Preanalytix GmbH (1).
Have NTW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2019-05-06.
Next steps
- Run an FDA pathway report with predicate devices for product code NTW
- Run a recall and safety report across every NTW manufacturer
- Watch product code NTW 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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