Cleared Traditional

LUPO-TEST REGEANT (K922326) - FDA 510(k) Clearance

Class I Hematology device.

K922326 · Graoipore , Ltd. · Hematology device
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Optimized for regulatory review, auditing and printing
Apr 1993
Decision
330d
Days
Class 1
Risk

K922326 is an FDA 510(k) clearance for the LUPO-TEST REGEANT. Classified as Reagent, Russel Viper Venom (product code GIR), Class I - General Controls.

Submitted by Graoipore , Ltd. (Pyrmont 2009 Australia, AU). The FDA issued a Cleared decision on April 6, 1993 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8950 - 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 Graoipore , Ltd. devices

Submission Details

510(k) Number K922326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1992
Decision Date April 06, 1993
Days to Decision 330 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
217d slower than avg
Panel avg: 113d · This submission: 330d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GIR Reagent, Russel Viper Venom
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8950
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.