This is a brief overview of information related to FDA’s approval of an Evaluation of Automatic Class III Designation to market this device.
Product Name: PAXgene™ Blood RNA System
Manufacturer: PreAnalytiX GmbH, c/o Becton, Dickinson and Company
Address: 1 Becton Drive, MC 300, Franklin Lakes, New Jersey 07417
Approval Date: April 18, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/k042613.pdf
What is it?
The PAXgene™ Blood RNA System is used to collect a patient’s blood sample and isolate RNA (ribonucleic acid) so it can be used in diagnostic lab tests. RNA is a molecule found in cells that translates genetic information from DNA to proteins produced by the cell. RNA can be used in lab tests to help confirm or rule out a suspected disease or condition.
The PAXgene™ Blood RNA System is made up of a plastic tube for collecting blood and a kit for purifying nucleic acid from a patient’s blood sample. The tube contains chemicals that can stabilize RNA from cells in the blood sample to keep the RNA intact for shipment at room temperature or storage for a short time at room temperature or in the refrigerator. The stabilized RNA is separated from other substances in the blood with the purification kit. The RNA obtained using this system can be used for reverse transcriptase polymerase chain reaction (RT-PCR) in in vitro molecular diagnostic lab tests.
How does it work?
- A patient’s blood is drawn into a plastic tube containing the stabilization solution
- RNA in the cells of the blood sample reacts with the chemicals in the stabilization solution.
- The chemicals prevent RNA from degrading when the blood sample is stored at room temperature or 4ºC for several days, or at -20 or -80ºC for several months.
- Using the purification kit, the stabilized RNA from the patient’s sample is separated from the other component of the human blood.
- The isolated intracellular RNA can be used for RT-PCR in in vitro molecular diagnostic lab testing.
When is it used?
The PAXgene™ Blood RNA System is used to help a medical professional obtain high quality intracellular RNA from whole blood for use in RT-PCR in vitro molecular diagnostic testing.
What will it accomplish?
The PAXgene™ Blood RNA System could standardize and improve the quality of intracellular RNA from patient’s whole blood drawn in the doctor’s office or diagnostic lab.
When should it not be used?
There are no contraindications for this device.