# K993174: Sysmex Automated Coagulation Analyzer, Model CA-6000

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Nov 9, 1999 after 48 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). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 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.

## Most influential descendants
- K020979: Sysmex Automated Coagulation Analyzer, Model #CA-7000 (2002), 1 descendant 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 Factor VIII; a2-Antiplasmin Calculated Parameters PT Ratio; Derived Fibrinogen PTINR; Factor Assays % Activity

Source page: https://510kreport.com/device/K993174
Methodology: https://510kreport.com/methodology