# K011665: BCT System

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 9, 2001 after 71 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K894052 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964139: Sysmex CA-6000, Dade Intl., Inc. (1997) Summary page 2.

## Recalls of this device
- Aug 27, 2004 · Not classified · Z-0042-05: APTT determinations when using affected rotors may lead to incorrectly shortened times

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

Source page: https://510kreport.com/device/K011665
Methodology: https://510kreport.com/methodology