Cleared Traditional

ROTA-DAN RAPID ROTAVIRUS EIA KIT (K951208) - FDA 510(k) Clearance

Class I Microbiology device.

K951208 · Eldan Technologies, Ltd. · Microbiology device
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Feb 1996
Decision
334d
Days
Class 1
Risk

K951208 is an FDA 510(k) clearance for the ROTA-DAN RAPID ROTAVIRUS EIA KIT. Classified as Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ), Class I - General Controls.

Submitted by Eldan Technologies, Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on February 14, 1996 after a review of 334 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Eldan Technologies, Ltd. devices

Submission Details

510(k) Number K951208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1995
Decision Date February 14, 1996
Days to Decision 334 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
232d slower than avg
Panel avg: 102d · This submission: 334d
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.