# K013114: BCS System

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Nov 9, 2001 after 52 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001145 (2000). 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)
- K001145: Sysmex Automated Coagulation Analyzer, Model CA-6000, Dade Behring, Inc. (2000) Summary page 1.

## Recalls of this device
- Jan 14, 2016 · Class II · Z-0824-2016: False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, h
- Dec 1, 2010 · Class II · Z-1867-2012: Firm has confirmed that if the Cleaner SCS vial becomes empty after processing a test for Antithrombin assay using the INNOVANCE(R) Antithrombin kit, and the test immediately following is an APTT base

## Indications for use
The BCS™ System is an automated coagulation analyzer for in vitro diagnostic use in clinical laboratories. The instrument performs the following parameters: o Activated Partial Thromboplastin Time (APTT) e Heparin e Antithrombin lila ¢ Lupus Anticoagulants ¢ Batroxobin ¢ Prothrombin Time (PT) ¢ D-dimer ¢ Plasminogen ¢ Deficient Plasmas e Protein C-clotting e Derived Fibrinogen ¢ Protein C-chromogenic ¢ Factor V Leiden e Thrombin Time ¢ Fibrinogen ¢ von Willebrand factor

Source page: https://510kreport.com/device/K013114
Methodology: https://510kreport.com/methodology