# K102164: Hemosil Protein S Activity Assay

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Mar 17, 2011 after 227 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: 2 generations back to K011424 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053499: Hemosil Pros, Instrumentation Laboratory CO (2006) Summary page 2.

## Indications for use
Automated coagulation functional assay for the quantitative determination of free Protein S in human citrated plasma as an aid in the diagnosis of hereditary and acquired Protein S deficiency, on the ACL TOP Family of analyzers.

Source page: https://510kreport.com/device/K102164
Methodology: https://510kreport.com/methodology