Cleared Traditional

DV TEST AND DVV CONFIRM (K940490) - FDA 510(k) Clearance

Class I Hematology device.

K940490 · American Diagnostica, Inc. · Hematology device
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Apr 1995
Decision
426d
Days
Class 1
Risk

K940490 is an FDA 510(k) clearance for the DV TEST AND DVV CONFIRM. Classified as Reagent, Russel Viper Venom (product code GIR), Class I - General Controls.

Submitted by American Diagnostica, Inc. (Greenwich, US). The FDA issued a Cleared decision on April 5, 1995 after a review of 426 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 American Diagnostica, Inc. devices

Submission Details

510(k) Number K940490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1994
Decision Date April 05, 1995
Days to Decision 426 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
313d slower than avg
Panel avg: 113d · This submission: 426d
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.