# K162688: Sysmex CS-2100i

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics Products GmbH
- Decided: Dec 26, 2016 after 90 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
For Sysmex® CS-2100i: 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 • Coagulation Factor V with Dade® Innovin® • Coagulation Factor VII with Dade® Innovin® • Protein C with Protein C Reagent • Antithrombin (AT) with INNOVANCE® Antithrombin • Protein C with Berichrom® Protein C • D-dimer with INNOVANCE® D-Dimer The performance of this device has not been established in neonate and pediatric patient populations. For Coagulation Factor V Deficient Plasma: Intended Use In vitro diagnostic reagent for the determination of the activity of coagulation factor V in human plasma. For Coagulation Factor VII Deficient Plasma: Intended Use In vitro diagnostic reagents for the determination of the activity of coagulation factor II (prothrombin), coagulation factor VII and coagulation factor X in human plasma by coagulometric methods. For Protein C Reagent: Intended Use Protein C Reagent is a coagulation test for the quantitative determination of protein C activity in human plasma. For Berichrom® Protein C: Intended Use For the quantitative determination of functionally active protein C using a chromogenic substrate as an aid in the diagnosis of inherited and acquired deficiencies.

Source page: https://510kreport.com/device/K162688
Methodology: https://510kreport.com/methodology