Xprecia Prime Coagulation System

FDA 510(k) K230802 · Universal Biosensors Pty, Ltd.

Substantially Equivalent

510(k) numberK230802

Submission

Device name
Xprecia Prime Coagulation System
Applicant
Universal Biosensors Pty, Ltd.
Rowville, AU
Received
March 23, 2023
Decision date
March 15, 2024
Decision
Substantially Equivalent (SESE)
Type
Dual Track 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GJS – Test, Time, Prothrombin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7750
Specialty
Hematology

Other 510(k)s with product code GJS

510(k)DeviceApplicantDecision
K253188CoaguChek XS Plus SystemGJS · Special Roche Diagnostics10/24/2025SE
K251564microINR SystemGJS · Traditional Iline Microsystems, S.L.07/21/2025SE
K243543microINR SystemGJS · Traditional Iline Microsystems, S.L.02/27/2025SE
K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemGJS · Traditional Abbott Laboratories07/14/2023SE
K231711microINR SystemGJS · Special Iline Microsystems, S.L.07/11/2023SE
K211485STA- NeoPTimalGJS · Traditional Diagnostica Stago S.A.S12/23/2022SE
K212779Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingGJS · Special Coagusense, Inc.10/05/2022SE
K213426HemosIL ReadiPlasTinGJS · Traditional Instrumentation Laboratory CO08/16/2022SE
K201185microINR SystemGJS · Traditional Iline Microsystems, S.L.12/18/2020SE
K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceGJS · Traditional Coagusense, Inc.02/21/2019SE

Questions and answers

When was Xprecia Prime Coagulation System cleared by the FDA?

Xprecia Prime Coagulation System (K230802) received a 510(k) decision of Substantially Equivalent on March 15, 2024, 358 days after the submission was received.

What is the product code of K230802?

The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.