Cleared Traditional

K951208 - ROTA-DAN RAPID ROTAVIRUS EIA KIT

K951208 is an FDA 510(k) clearance for ROTA-DAN RAPID ROTAVIRUS EIA KIT, manufactured by Eldan Technologies, Ltd.. The device is a Class 1 Microbiology device with product code LIQ cleared through the Traditional 510(k) pathway after a 334-day FDA review.

K951208 · Eldan Technologies, Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K951208

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
232d slower than avg
Panel avg: 102d · This submission: 334d
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 K951208.
IMMUNOCARD STAT! ROTAVIRUS
K971585 · Meridian Diagnostics, Inc. · Aug 1997
ROTAVIRUS EIA
K964424 · Trinity Biotech, Inc. · Aug 1997
VIDAS ROTAVIRUS ASSAY
K965092 · Biomerieux Vitek, Inc. · May 1997
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