# K180486: HemosIL Factor XII Deficient Plasma

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: Mar 22, 2018 after 27 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 K893534 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043459: Hemosil Factor Xii Deficient Plasma, Instrumentation Laboratory CO (2005) Summary page 4.

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

Source page: https://510kreport.com/device/K180486
Methodology: https://510kreport.com/methodology