Cleared Dual Track

K230802 - Xprecia Prime Coagulation System

K230802 is an FDA 510(k) clearance for Xprecia Prime Coagulation System, manufactured by Universal Biosensors Pty, Ltd.. The device is a Class 2 Hematology device with product code GJS cleared through the Dual Track 510(k) pathway after a 358-day FDA review.

K230802 · Universal Biosensors Pty, Ltd. · Hematology device
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Optimized for regulatory review, auditing and printing
Mar 2024
Decision
358d
Days
Class 2
Risk

K230802 is an FDA 510(k) clearance for the Xprecia Prime Coagulation System. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Universal Biosensors Pty, Ltd. (Rowville, AU). The FDA issued a Cleared decision on March 15, 2024 after a review of 358 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Universal Biosensors Pty, Ltd. devices

FDA 510(k) Submission Details - K230802

510(k) Number K230802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2023
Decision Date March 15, 2024
Days to Decision 358 days
Submission Type Dual Track
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
245d slower than avg
Panel avg: 113d · This submission: 358d
Pathway characteristics

GJS Device Classification - Class 2, Special Controls

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GJS Test, Time, Prothrombin

All 102
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