# K173202: CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Sekisui Medical Co., Ltd.
- Decided: May 9, 2018 after 219 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K002400 (2000). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160276: Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl Top 300 CTS), Instrumentation Laboratory CO (2016) Summary page 5.
- K062431: Hemosil Liquid Antithrombin, Instrumentation Laboratory CO (2006) Summary page 5.
- K041905: Hemosil Calibration Plasma, Instrumentation Laboratory CO (2004) Summary page 5.
- K021023: Hemosil Normal Control (Assayed); Hemosil Normal Control 1 (Unassayed), Instrumentation Laboratory CO (2002) Summary page 5.
- K021024: Hemosil High Abnormal Control Assayed, Instrumentation Laboratory CO (2002) Summary page 5.

## Indications for use
CP3000 analyzer The CP3000 is a fully automated, random-access in vitro blood coagulation analyzer intended for use by healthcare professionals in the clinical laboratory. The CP3000 analyzer is designed to process plasma samples photometrically using chromogenic assays. Coagpia AT Reagent Coagpia AT Reagent is intended for the quantitative determination of antithrombin (AT) activity in human 3.2% citrated venous plasma. The reagent is intended for use on Sekisui CP3000 analyzers by trained laboratory personnel in clinical laboratories. For in vitro diagnostic use. Coagpia Calibrator The Coagpia Calibrator is intended for use as a calibration plasma for the following Sekisui coagulation assay on Sekisui CP3000 analyzers by trained laboratory personnel in clinical laboratories. For in vitro diagnostic use. - Coagpia AT Reagent Coagpia Control Set The Coagpia Control Set contains 2 levels of assayed plasma intended for the quality control of the following Sekisui coagulation assay on Sekisui CP3000 analyzers by trained laboratory personnel. For in vitro diagnostic use. - Coagpia AT Reagent

Source page: https://510kreport.com/device/K173202
Methodology: https://510kreport.com/methodology