Cleared Traditional

SLIDEX ROTA-KIT 2 (K895805) - FDA 510(k) Clearance

Class I Microbiology device.

K895805 · Vitek Systems, Inc. · Microbiology device
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Feb 1991
Decision
516d
Days
Class 1
Risk

K895805 is an FDA 510(k) clearance for the SLIDEX ROTA-KIT 2. Classified as Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ), Class I - General Controls.

Submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on February 26, 1991 after a review of 516 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Microbiology submissions.

View all Vitek Systems, Inc. devices

Submission Details

510(k) Number K895805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1989
Decision Date February 26, 1991
Days to Decision 516 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
414d slower than avg
Panel avg: 102d · This submission: 516d
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.