Cleared Special

K132076 - REAGENT, RUSSEL VIPER VENOM - LA CONFIRM (FDA 510(k) Clearance)

Class I Hematology device.

K132076 · Dsrv, Inc. · Hematology device
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Jan 2014
Decision
191d
Days
Class 1
Risk

K132076 is an FDA 510(k) clearance for the REAGENT, RUSSEL VIPER VENOM - LA CONFIRM. Classified as Reagent, Russel Viper Venom (product code GIR), Class I - General Controls.

Submitted by Dsrv, Inc. (Clarkston, US). The FDA issued a Cleared decision on January 10, 2014 after a review of 191 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dsrv, Inc. devices

Submission Details

510(k) Number K132076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2013
Decision Date January 10, 2014
Days to Decision 191 days
Submission Type Special
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 113d · This submission: 191d
Pathway characteristics
Modification to existing cleared device.

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.