# K992321: Sysmex Automated Coagulation Analyzer, Model CA-6000

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 17, 1999 after 67 days
- Product code: GKP (Instrument, Coagulation, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K926551 (1995). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955278: Behring Coagulation Timer, Behring Diagnostics, Inc. (1996) Summary page 1.
- K924124: Behring Fibrintimer a, Behring Diagnostics, Inc. (1992) Summary page 1.

## Most influential descendants
- K020979: Sysmex Automated Coagulation Analyzer, Model #CA-7000 (2002), 1 descendant of its own
- K993299: Sysmex Automated Coagulation Analyzer, Model CA-1500 (1999), 1 descendant of its own
- K162420: Sysmex Automated Blood Coagulation Analyzer CS-5100 (2016), 0 descendants of its own
- K031377: Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540. -550, and -560 (2003), 0 descendants of its own

## Indications for use
The intended use of the Sysmex® CA-6000 is as a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories. The instrument uses citrated human plasma to perform the following parameters and calculated parameters: Clotting Analysis Parameters Prothrombin Time (PT) Extrinsic Factors (II, V, VII, X) Activated Partial Thromboplastin Time (APTT) Intrinsic Factors (VIII, IX, XI, XII) Fibrinogen (Clauss) Batroxobin Thrombin Time Protein C Chromogenic Analysis Parameters Antithrombin III Protein C Plasminogen Heparin Calculated Parameters PT Ratio Derived Fibrinogen PTINR

Source page: https://510kreport.com/device/K992321
Methodology: https://510kreport.com/methodology