# K972075: Vacutainer Brand PPT Plasma Preparation Tube

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Vacutainer Systems
- Decided: Feb 24, 1998 after 266 days
- Product code: PJE (Blood/Plasma Collection Device For Dna Testing)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945952 (1995). 2 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953463: Vacutainer Plus Tubes, Becton Dickinson Vacutainer Systems (1995)
- K945952: Vacutainer (R) Brand Plus PST (TM) Plasma Separation Tube, Bd Becton Dickinson Vacutainer Systems Preanalytic (1995) Summary page 4.

## Most influential descendants
- K110701: Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500 (2011), 6 descendants of its own
- K141410: Oragene DX Ogd-500.001 (2015), 3 descendants of its own
- K152556: Oragene Dx (2016), 2 descendants of its own
- K192920: Oragene®•Dx (2020), 1 descendant of its own
- K142821: PAXgene Blood DNA Tube (2015), 1 descendant of its own

## Indications for use
The VACUTAINER® Brand PPT™ Plasma Preparation Tube with EDTA anticoagulant and a gel barrier material are evacuated blood collection tubes which provide a means of collecting, processing and transporting blood in a closed plastic tube. When the Tube is used together with VACUTAINER® Brand needles and holders, it is a closed system for the collection of venous blood with the same indications identified here. Blood collected in a tube containing EDTA anticoagulant and gel barrier material can be primarily used to provide undiluted plasma for use in molecular diagnostic test methods; including but not limited to Polymerase Chain Reaction (PCR) and branched-DNA (bDNA). The specimen may also be used for other testing that requires an undiluted plasma sample as determined by the laboratory.

Source page: https://510kreport.com/device/K972075
Methodology: https://510kreport.com/methodology