# K022977: Stratus CS D-Dimer Calpak Calibrator, Model Cddmr-C

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Nov 27, 2002 after 82 days
- Product code: DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 864.7320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) VIDAS D-dimer (DD) Calibrator: named in the summary without a submission number

## Most influential descendants
- K063356: Stratus CS Acute Care D-Dimer Testpak, Dilpak, Calpak (2007), 1 descendant of its own
- K081732: Innovance D-Dimer and Innovance D-Dimer Controls (2008), 0 descendants of its own

## Indications for use
The Stratus® CS D-dimer CalPak is an in vitro diagnostic product used to calibrate the Stratus® D-dimer method on the Stratus® CS STAT fluorometric analyzer. This calibrator is intended for medical purposes to establish points of reference that are used in the determination of D-dimer concentration in human specimens.

Source page: https://510kreport.com/device/K022977
Methodology: https://510kreport.com/methodology