# K993299: Sysmex Automated Coagulation Analyzer, Model CA-1500

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Dec 7, 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: 3 generations back to K926551 (1995). 6 ancestors in all.
1 later device descends from it; 1 cites 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)
- K964139: Sysmex CA-6000, Dade Intl., Inc. (1997) Summary page 1.
- K992321: Sysmex Automated Coagulation Analyzer, Model CA-6000, Dade Behring, Inc. (1999) Summary page 1.
- K955278: Behring Coagulation Timer, Behring Diagnostics, Inc. (1996) Summary page 1.

## Most influential descendants
- K162420: Sysmex Automated Blood Coagulation Analyzer CS-5100 (2016), 0 descendants of its own

## Indications for use
The intended use of the Sysmex® CA-1500 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) e Extrinsic Factors (II, V, VII, X) e Activated Partial Thromboplastin Time (APTT) e Intrinsic Factors (VIIL, IX, XI, XII) ¢ Fibrinogen (Clauss) Chromogenic Analysis Parameters ¢ Antithrombin III Calculated Parameters s PT Ratio e Derived Fibrinogen e PTINR ¢ Factor Assays % Activity e PT%

Source page: https://510kreport.com/device/K993299
Methodology: https://510kreport.com/methodology