Cleared Traditional

LUPO-TEST REAGENT (K903037) - FDA 510(k) Clearance

Class I Hematology device.

K903037 · Gradipore , Ltd. · Hematology device
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Dec 1990
Decision
159d
Days
Class 1
Risk

K903037 is an FDA 510(k) clearance for the LUPO-TEST REAGENT. Classified as Reagent, Russel Viper Venom (product code GIR), Class I - General Controls.

Submitted by Gradipore , Ltd. (Pyrmont, AU). The FDA issued a Cleared decision on December 17, 1990 after a review of 159 days - an extended review cycle.

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. Standard predicate reliance. 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 Gradipore , Ltd. devices

Submission Details

510(k) Number K903037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1990
Decision Date December 17, 1990
Days to Decision 159 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 113d · This submission: 159d
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.