# K024082: Hemosil Factor Vii Deficient Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Feb 12, 2003 after 63 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
Longest line of descent: 1 generation back to K893535 (1989). 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)
- K893535: Factor Vii Deficient Plasma, Medical Diagnostic Technologies, Inc. (1989) Summary page 1.
- K002400: Modification of Acl Advance, Instrumentation Laboratory CO (2000)

## Indications for use
HemosIL Factor VII Deficient Plasma is human plasma immunodepleted of Factor VII and intended for the in vitro diagnostic quantitative determination of Factor VII activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.

Source page: https://510kreport.com/device/K024082
Methodology: https://510kreport.com/methodology