# K151259: Sysmex Automated Blood Coagulation Analyzer CS-2100i

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics Products GmbH
- Decided: Jan 26, 2016 after 259 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- 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 K011235 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011235: Sysmex Automated Coagulation Analyzer / Model # CA-1500, Dade Behring, Inc. (2001) Summary page 5.

## Indications for use
The Sysmex CS-2100i is a fully automated blood coagulation analyzer intended for in vitro diagnostic use using plasma collected from venous blood samples in 3.2% sodium citrate tubes to analyze clotting, chromogenic and immunoassay methods in the clinical laboratory. For determination of: • Prothrombin Time (PT) seconds and PT INR with Dade® Innovin® • Activated Partial Thromboplastin Time (APTT) with Dade® Actin® FSL • Fibrinogen (Fbg) with Dade® Thrombin Reagent • Antithrombin (AT) with INNOVANCE® Antithrombin • D-dimer with INNOVANCE® D-Dimer. The performance of this device has not been established in neonate and pediatric patient populations.

Source page: https://510kreport.com/device/K151259
Methodology: https://510kreport.com/methodology