Cleared Traditional

K884017 - ROTACUBE

K884017 is an FDA 510(k) clearance for ROTACUBE, manufactured by Difco Laboratories, Inc.. The device is a Class 1 Microbiology device with product code LIQ cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K884017 · Difco Laboratories, Inc. · Microbiology device
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Jan 1989
Decision
124d
Days
Class 1
Risk

K884017 is an FDA 510(k) clearance for the ROTACUBE. Classified as Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ), Class I - General Controls.

Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on January 24, 1989 after a review of 124 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 Difco Laboratories, Inc. devices

FDA 510(k) Submission Details - K884017

510(k) Number K884017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1988
Decision Date January 24, 1989
Days to Decision 124 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 102d · This submission: 124d
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 K884017.
KALLESTAD ROTAVIRUS MICROPLATE
K915137 · Bio-Rad Laboratories, Inc. · Mar 1992
DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440
K912666 · Dako Corp. · Feb 1992
SLIDEX ROTA-KIT 2
K895805 · Vitek Systems, Inc. · Feb 1991
ORTHO* ROTAVIRUS ANTIGEN ELISA TEST
K883935 · Ortho Diagnostic Systems, Inc. · Jan 1989
ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST
K883940 · Ortho Diagnostic Systems, Inc. · Jan 1989
RESUBMITTED ABBOTT TESTPACK ROTAVIRUS
K880821 · Abbott Laboratories · May 1988