# K041905: Hemosil Calibration Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Sep 28, 2004 after 75 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K905203 (1990). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905203: Coagulation Reference Plasma, Normal, Medical Diagnostic Technologies, Inc. (1990) Summary page 1.
- K002400: Modification of Acl Advance, Instrumentation Laboratory CO (2000) Summary page 1.

## Most influential descendants
- K090563: Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software) (2009), 1 descendant of its own
- K173202: CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set (2018), 0 descendants of its own
- K093848: PT-Multi-Calibrator, Model OPAT07 (2010), 0 descendants of its own
- K092113: Sta - Free PS Calibrator (2009), 0 descendants of its own

## Indications for use
HemosIL Calibration plasma is intended for the calibration of coagulation assays on IL and ELECTRA Coagulation Systems. The calibration plasma is prepared using citrated plasma plasmapheresed from healthy donors to maintain the characteristics of a normal plasma pool.

Source page: https://510kreport.com/device/K041905
Methodology: https://510kreport.com/methodology