Cleared Traditional

HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM (K110031) - FDA 510(k) Clearance

Class I Hematology device.

K110031 · Instrumentation Laboratory CO · Hematology device
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Aug 2011
Decision
231d
Days
Class 1
Risk

K110031 is an FDA 510(k) clearance for the HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM. Classified as Reagent, Russel Viper Venom (product code GIR), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on August 24, 2011 after a review of 231 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.

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Submission Details

510(k) Number K110031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2011
Decision Date August 24, 2011
Days to Decision 231 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
118d slower than avg
Panel avg: 113d · This submission: 231d
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.