# K090563: Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software)

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Oct 9, 2009 after 221 days
- Product code: GGN (Plasma, Coagulation Control)
- Device class: 2
- Regulation: 21 CFR 864.5425
- 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 K905203 (1990). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010750: Pacific Hemostasis Inr Control Plasmas, Model Catalog 100560, Fisher Diagnostics (2001) Summary page 1.
- K041905: Hemosil Calibration Plasma, Instrumentation Laboratory CO (2004) Summary page 1.

## Most influential descendants
- K093848: PT-Multi-Calibrator, Model OPAT07 (2010), 0 descendants of its own

## Indications for use
HemosIL INR Validate is a tri-level quality control intended to monitor the accuracy of INR (International Normalized Ratio) reporting with designated HemosIL PT reagents on IL Coagulation Systems in conjunction with the ISIweb software. * HemosIL ISI Calibrate is a set of four certified plasmas intended to establish a laboratory's instrument/ reagent specific local ISI (International Sensitivity Index) and Mean Normal Prothrombin Time (MNPT) with designated HemosIL PT reagents on IL Coagulation Systems in conjunction with the ISIweb software. · ISIweb Software is a web-based service to customers, used in conjunction with HemosIL INR Validate and HemosIL ISI Calibrate with designated HemosIL PT reagents on IL Coagulation Systems, whereby the PT seconds and INR results can be entered and calculated through a web-based interface (ISIweb software).

Source page: https://510kreport.com/device/K090563
Methodology: https://510kreport.com/methodology