Cleared Traditional

K965092 - VIDAS ROTAVIRUS ASSAY

K965092 is the FDA 510(k) clearance for VIDAS ROTAVIRUS ASSAY by Biomerieux Vitek, Inc.. It is a Class 1 Microbiology device (product code LIQ) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K965092 · Biomerieux Vitek, Inc. · Microbiology device
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May 1997
Decision
137d
Days
Class 1
Risk

K965092 is an FDA 510(k) clearance for the VIDAS ROTAVIRUS ASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ), Class I - General Controls.

Submitted by Biomerieux Vitek, Inc. (Rockland, US). The FDA issued a Cleared decision on May 5, 1997 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3405 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomerieux Vitek, Inc. devices

Submission Details

510(k) Number K965092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1996
Decision Date May 05, 1997
Days to Decision 137 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 102d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3405
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 - LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus

All 18
Devices cleared under the same product code (LIQ) and FDA review panel - the closest regulatory comparables to K965092.
SAS ROTA TEST
K990842 · Sa Scientific, Inc. · Aug 1999
VIDAS ROTAVIRUS (RTV) ASSAY
K972895 · Biomerieux Vitek, Inc. · Oct 1997
IMMUNOCARD STAT! ROTAVIRUS
K971585 · Meridian Diagnostics, Inc. · Aug 1997
IMMUNOCARD ROTAVIRUS
K933587 · Meridian Diagnostics, Inc. · Feb 1994
KALLESTAD ROTAVIRUS MICROPLATE
K915137 · Bio-Rad Laboratories, Inc. · Mar 1992
DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440
K912666 · Dako Corp. · Feb 1992