# K992423: Sysmex Automated Coagulation Analyzer, Model CA-500

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 21, 1999 after 62 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.
No later device cites it as a predicate yet.
0 of 4 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.
- K926551: Behring Fibrintimer a, Behring Diagnostics, Inc. (1995) Summary page 1.

## Indications for use
The intended use of the Sysmex® CA-500 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) Activated Partial Thromboplastin Time (APTT) Fibrinogen (Clauss) Batroxobin Protein C Chromogenic Analysis Parameters Antithrombin III Heparin Protein C Calculated Parameters PT Ratio PTINR Derived Fibrinogen

Source page: https://510kreport.com/device/K992423
Methodology: https://510kreport.com/methodology