Cleared Dual Track

K230802 - Xprecia Prime Coagulation System (FDA 510(k) Clearance)

Class II Hematology device cleared through the Dual Track 510(k) pathway - typically does not require clinical trials.

K230802 · Universal Biosensors Pty, Ltd. · Hematology device
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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

Submission Details

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

Device Classification

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 126
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