# K040362: Diapharma Factor X Kit

- Pathway: 510(k) (Traditional)
- Applicant: Diapharma Group, Inc.
- Decided: Jul 12, 2004 after 150 days
- Product code: GJT (Plasma, Coagulation Factor Deficient)
- Device class: 2
- Regulation: 21 CFR 864.7290
- 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
Factor X activity is useful for monitoring patients on oral anticoagulant therapy (warfarin) where baseline PT values may be prolonged and TNR results are not reliable, such as in OAC patients with lupus inhibitors. The DiaPharma FX kit provides health care providers with a tool for clinical decision making. The DiaPharma Factor X Kit is also useful for screening for factor X deficiencies.

Source page: https://510kreport.com/device/K040362
Methodology: https://510kreport.com/methodology