# K092113: Sta - Free PS Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostica Stago, Inc.
- Decided: Nov 13, 2009 after 122 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: 2 generations back to K905203 (1990). 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)
- K041905: Hemosil Calibration Plasma, Instrumentation Laboratory CO (2004) Summary page 1.

## Indications for use
STA® - Free PS Calibrator kit is a set of calibrator plasmas intended for use with analyzers of the STA® line suitable to these reagents for the calibration of free protein S assays by the immuno-turbidimetric method, STA® - Liatest® Free PS.

Source page: https://510kreport.com/device/K092113
Methodology: https://510kreport.com/methodology