Sonoclot® kACT Kit

Basic Information

• Brand Name: Sonoclot® kACT Kit
• Primary DI: B55880004011
• Version / Model: 800-0401
• Catalog Number: 800-0401
• Company Name: SIENCO, INC.
• Labeler DUNS: 064039514
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2021-07-19
• Public Version: 1
• Public Version Date: 2021-07-27
• Public Version Status: New
• Public Device Record Key: 8ddc9c4a-ebdb-49b5-8ec2-fe3829b06bbf

Device Description

The kACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The kACT test is a kaolin activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. The kACT Kit is intended for high dose heparin management with or without aprotinin. The kACT test provides quantitative Onset/ACT and Clot Rate results with the Sonoclot Analyzer. The kACT test is not intended for platelet function monitoring. Each kit contains 24 lidded blue plastic activation cuvettes, 24 probes, and instructions for use. The activation cuvettes contain a controlled amount of kaolin and a magnetic stir bar.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	864.5425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55996	Multiple coagulation factor IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen, using a clotting method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	B55880004010	HIBCC
Primary	B55880004011	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K952560	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius