Cleared Traditional

LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA (K083878) - FDA 510(k) Clearance

Class I Hematology device.

K083878 · R2 Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
543d
Days
Class 1
Risk

K083878 is an FDA 510(k) clearance for the LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA. Classified as Reagent, Russel Viper Venom (product code GIR), Class I - General Controls.

Submitted by R2 Diagnostics, Inc. (South Bend, US). The FDA issued a Cleared decision on June 25, 2010 after a review of 543 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all R2 Diagnostics, Inc. devices

Submission Details

510(k) Number K083878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2008
Decision Date June 25, 2010
Days to Decision 543 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
430d slower than avg
Panel avg: 113d · This submission: 543d
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.