# K092937: Sta-Hybrid Hep Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostica Stago, Inc.
- Decided: Aug 2, 2010 after 312 days
- Product code: JIT (Calibrator, Secondary)
- 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 K854762 (1986). 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)
- K010350: Sta -Calibrator HBPM/LMWH Kit, Diagnostica Stago, Inc. (2001) Summary page 1.
- K854762: Hepanorm Calibration Plasma Set, American Bioproducts Co. (1986) Summary page 1.

## Indications for use
The STA® - Hybrid Hep Calibrator is a set of calibrator plasmas intended for use with analyzers of the STA® line suitable to these reagents, for the calibration of heparin (UFH and LMWH) activity assay by measuring the anti-Xa activity using the chromogenic method, STA® - Rotachrom® Heparin.

Source page: https://510kreport.com/device/K092937
Methodology: https://510kreport.com/methodology