# K031829: Hemosil Factor IX Deficient Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Jul 31, 2003 after 48 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 K893524 (1989). 2 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K893524: Factor IX Deficient Plasma, Medical Diagnostic Technologies, Inc. (1989) Summary page 1.
- K002400: Modification of Acl Advance, Instrumentation Laboratory CO (2000)

## Most influential descendants
- K230852: HemosIL Chromogenic Factor IX (2023), 0 descendants of its own
- K214002: CRYOcheck Chromogenic Factor IX (2022), 0 descendants of its own

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

Source page: https://510kreport.com/device/K031829
Methodology: https://510kreport.com/methodology