# K020840: Vital Scientific PT with Calcium

- Pathway: 510(k) (Traditional)
- Applicant: Vital Scientific N.V.
- Decided: May 15, 2002 after 61 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933252 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981479: IL Test PT-Fibrinogen Recombinant, Instrumentation Laboratory CO (1998) Summary page 1.

## Indications for use
The Vital Scientific PT with Calcium is an in-vitro diagnostic reagent intended for use for the performance of one-stage Prothrombin Time (PT) Testing and assays which are based on a modified prothrombin time.

Source page: https://510kreport.com/device/K020840
Methodology: https://510kreport.com/methodology