# K110237: Hemosil Factor Viii Deficient Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Jul 8, 2011 after 163 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: 2 generations back to K893525 (1989). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034007: Hemosil Factor Viii Deficient Plasma, Instrumentation Laboratory CO (2004) Summary page 1.

## Most influential descendants
- K222831: CRYOcheck Factor VIII Deficient Plasma with VWF (2023), 0 descendants of its own

## Indications for use
HemosiL Factor VilI deficient plasma is human plasma, depleted of Factor ViII, which is intended for the in vitro diagnostic quantitative determination of Factor ViII activity in citrated plasma, based on the activated partial thromboplastin time (APrT) assay, on the ACL TOP®0 Family analyzers. HemosIL Factor Vill deficient plasma is indicated for use on patients who are suspected of congenital or acquired deficiency based on the activated partial thromboplastin time (APTT) assay results.

Source page: https://510kreport.com/device/K110237
Methodology: https://510kreport.com/methodology