NTW · System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
Immunology · 21 CFR 866.4070 · Class 2
Overview
| Product Code | NTW |
|---|---|
| Device Name | System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test |
| Regulation | 21 CFR 866.4070 |
| Device Class | Class 2 |
| Review Panel | Immunology |
Identification
RNA Preanalytical Systems are devices intended to collect, store, and transport patient specimens, and stabilize intracellular RNA from the specimens, for subsequent isolation and purification of the intracellular RNA for RT-PCR used in in vitro molecular diagnostic testing.
Classification Rationale
Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization and Purification System for RT-PCR Used in Molecular Diagnostic Testing).” See § 866.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization and Purification System for RT-PCR Used in Molecular Diagnostic Testing).” See § 866.1(e) for the availability of this guidance document.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K082150 | MODIFICATION TO PAXGENE BLOOD RNA SYSTEM | Preanalytix GmbH | Feb 4, 2009 | SESE |
| DEN050003 | PAXGENE BLOOD RNA SYSTEM | Preanalytix GmbH | Apr 18, 2005 | DENG |
Top Applicants
- Preanalytix GmbH — 2 clearances
