Cleared Special

K132130 - REAGENT, RUSSEL VIPER VENOM - LA SCREEN

K132130 is an FDA 510(k) clearance for REAGENT, manufactured by Dsrv, Inc.. The device is a Class 1 Hematology device with product code GIR cleared through the Special 510(k) pathway after a 184-day FDA review.

K132130 · Dsrv, Inc. · Hematology device
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Jan 2014
Decision
184d
Days
Class 1
Risk

K132130 is an FDA 510(k) clearance for the REAGENT, RUSSEL VIPER VENOM - LA SCREEN. 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 184 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.

FDA 510(k) Submission Details - K132130

510(k) Number K132130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2013
Decision Date January 10, 2014
Days to Decision 184 days
Submission Type Special
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 113d · This submission: 184d
Pathway characteristics
Modification to existing cleared device.

GIR Device Classification - Class 1, General Controls

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.

Regulatory Peers - GIR Reagent, Russel Viper Venom

All 15
Devices cleared under the same product code (GIR) and FDA review panel - the closest regulatory comparables to K132130.
REAGENT, RUSSEL VIPER VENOM - LA CONFIRM
K132076 · Dsrv, Inc. · Jan 2014
HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
K110031 · Instrumentation Laboratory CO · Aug 2011
LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA
K083878 · R2 Diagnostics, Inc. · Jun 2010
STA - STACLOT DRVV SCREEN
K061805 · Diagnostica Stago, Inc. · Dec 2006
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094
K000527 · Sigma Diagnostics, Inc. · Apr 2000
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
K000528 · Sigma Diagnostics, Inc. · Apr 2000
K132130 · REAGENT, RUSSEL VIPER VENOM - LA SCREEN
Download PDF Dsrv, Inc.