# K042941: Dade Behring Heparin Calibrator and Controls

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Dec 2, 2004 after 38 days
- Product code: GIZ (Plasma, Control, Normal)
- 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: 1 generation back to K812424 (1981). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K843202: Heparin Calibrator Aca, E.I. Dupont DE Nemours & Co., Inc. (1984) Summary page 1.
- K812424: CI-Trol Heparin Controls, Low/High, American Dade (1981) Summary page 1.

## Most influential descendants
- K083175: Berichrom Heparin UF Calibrator, Berichrom Heparin UF Control 1, and Berichrom Heparin UF Control 2 (2009), 0 descendants of its own
- K051472: Biophen LMWH Control, LMWH Control Low, Ufh Control, Heparin Calibrator & Ufh Calibrator (2005), 0 descendants of its own

## Indications for use
The Dade Behring Heparin Calibrator is an in vitro diagnostic product used to calibrate the Berichrom® Heparin assay for the measurement of unfractionated heparin. Dade Behring Heparin Controls are in vitro diagnostic products intended to be used as assayed, unfractionated heparin quality control materials for the Berichrom® Heparin assay.

Source page: https://510kreport.com/device/K042941
Methodology: https://510kreport.com/methodology