# K093848: PT-Multi-Calibrator, Model OPAT07

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Dec 20, 2010 after 369 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: 3 generations back to K905203 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090563: Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software), Instrumentation Laboratory CO (2009) Summary page 2.
- (no number) HemosIL INR Validate®: named in the summary without a submission number
- (no number) HemosIL-ISI Calibrate: named in the summary without a submission number

## Indications for use
Intended Use: PT-Multi Calibrator is intended as a calibrator set for local PT/INR calibration and/or local verification of the INR system for plasma based procedures with designated Siemens thromboplastins Dade® Innovin® or Thromborel® S on the BCS® BOS® XP Systems.

Source page: https://510kreport.com/device/K093848
Methodology: https://510kreport.com/methodology