Cleared Traditional

K912666 - DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440

K912666 is the FDA 510(k) clearance for DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 by Dako Corp.. It is a Class 1 Microbiology device (product code LIQ) cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K912666 · Dako Corp. · Microbiology device
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Feb 1992
Decision
241d
Days
Class 1
Risk

K912666 is an FDA 510(k) clearance for the DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440. Classified as Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ), Class I - General Controls.

Submitted by Dako Corp. (Denmark, DK). The FDA issued a Cleared decision on February 14, 1992 after a review of 241 days - an extended review cycle.

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 Dako Corp. devices

Submission Details

510(k) Number K912666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1991
Decision Date February 14, 1992
Days to Decision 241 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 102d · This submission: 241d
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 K912666.
VIDAS ROTAVIRUS ASSAY
K965092 · Biomerieux Vitek, Inc. · May 1997
IMMUNOCARD ROTAVIRUS
K933587 · Meridian Diagnostics, Inc. · Feb 1994
KALLESTAD ROTAVIRUS MICROPLATE
K915137 · Bio-Rad Laboratories, Inc. · Mar 1992
SLIDEX ROTA-KIT 2
K895805 · Vitek Systems, Inc. · Feb 1991
ROTACUBE
K884017 · Difco Laboratories, Inc. · Jan 1989
ORTHO* ROTAVIRUS ANTIGEN ELISA TEST
K883935 · Ortho Diagnostic Systems, Inc. · Jan 1989