# K992959: Behring Coagulation System (BCS)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jan 11, 2000 after 131 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 K842085 (1984). 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)
- K842085: Automated Eia Microplate Reader EL310, Bio-Tek Instruments, Inc. (1984) Summary page 1.

## Indications for use
The Behring Coagulation System (BCS) is an automated coagulation analyzer for in vitro diagnostic use in clinical laboratories. The instrument performs the following parameters: Prothrombin Time (PT) Fibrinogen Activated Pattial Thromboplastin Time (APTT) Heparin Antithrombinillla Plasminogen Batroxibin Protein C-clotting D-dimer Protein C-chromogenic Deficient Plasmas Thrombin Time Von Willebrand factor

Source page: https://510kreport.com/device/K992959
Methodology: https://510kreport.com/methodology