# K053499: Hemosil Pros

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: Jan 13, 2006 after 28 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- 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 K011424 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011424: IL Test Pros, Instrumentation Laboratory CO (2001)

## Most influential descendants
- K102164: Hemosil Protein S Activity Assay (2011), 0 descendants of its own

## Indications for use
HemosIL Pros is a functional assay for the quantitative determination of free Protein S in human citrated plasma on IL coagulation systems as an aid in the diagnosis of hereditary and acquired Protein S deficiency. This in vitro diagnostic test determines the functional activity of free Protein S by measuring the degree of prolongation of a prothrombin time in the presence of the tissue factor, phospholipids, calcium ions and activated Protein C. The Protein S activity is proportional to the prolongation of the clotting time of a Protein S deficient plasma to which the diluted sample was added.

Source page: https://510kreport.com/device/K053499
Methodology: https://510kreport.com/methodology