# K031359: S-Monovette Edta K2-Gel

- Pathway: 510(k) (Traditional)
- Applicant: Sarstedt, Inc.
- Decided: Sep 12, 2003 after 135 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The S-Monovette® EDTA K2-Gel provides a means for collection, processing and transportation of a plasma specimen in a closed system. Following collection of the blood, the S-Monovette® EDTA K2-Gel is to be centrifuged such that the gel creates a barrier between the plasma and cellular components. The plasma specimen can then be removed for testing or the specimen can be transported for testing at another location without the plasma mixing with the cellular components. The plasma specimen produced by the S-Monovette® EDTA K2-Gel can be used for Nucleic Acid Testing (NAT) by methods such as PCR — Polymerase Chain Reaction or for other procedures where the laborztory has determined that a plasma specimen is appropriate.

Source page: https://510kreport.com/device/K031359
Methodology: https://510kreport.com/methodology