# K023839: Hemosil Factor V Deficient Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Jan 14, 2003 after 57 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 K893533 (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)
- K893533: Factor V Deficient Plasma, Medical Diagnostic Technologies, Inc. (1989) Summary page 1.
- K002400: Modification of Acl Advance, Instrumentation Laboratory CO (2000)

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

Source page: https://510kreport.com/device/K023839
Methodology: https://510kreport.com/methodology