Cleared Traditional

K912666 - DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440

K912666 is an FDA 510(k) clearance for DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440, manufactured by Dako Corp.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K912666

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.

LIQ Device Classification - Class 1, General Controls

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 27
Devices cleared under the same product code (LIQ) and FDA review panel - the closest regulatory comparables to K912666.
DIARLEX ROTA-ADENO
K942286 · Orion Diagnostica, Inc. · Dec 1994
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