Cleared Traditional

K964424 - ROTAVIRUS EIA

K964424 is an FDA 510(k) clearance for ROTAVIRUS EIA, manufactured by Trinity Biotech, Inc.. The device is a Class 1 Microbiology device with product code LIQ cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K964424 · Trinity Biotech, Inc. · Microbiology device
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Aug 1997
Decision
276d
Days
Class 1
Risk

K964424 is an FDA 510(k) clearance for the ROTAVIRUS EIA. Classified as Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ), Class I - General Controls.

Submitted by Trinity Biotech, Inc. (Irvine, US). The FDA issued a Cleared decision on August 8, 1997 after a review of 276 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 Trinity Biotech, Inc. devices

FDA 510(k) Submission Details - K964424

510(k) Number K964424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1996
Decision Date August 08, 1997
Days to Decision 276 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
174d slower than avg
Panel avg: 102d · This submission: 276d
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 K964424.
SAS ROTA TEST
K990842 · Sa Scientific, Inc. · Aug 1999
VIDAS ROTAVIRUS (RTV) ASSAY
K972895 · Biomerieux Vitek, Inc. · Oct 1997
IMMUNOCARD STAT! ROTAVIRUS
K971585 · Meridian Diagnostics, Inc. · Aug 1997
VIDAS ROTAVIRUS ASSAY
K965092 · Biomerieux Vitek, Inc. · May 1997
ROTA-DAN RAPID ROTAVIRUS EIA KIT
K951208 · Eldan Technologies, Ltd. · Feb 1996
DIARLEX ROTA-ADENO
K942286 · Orion Diagnostica, Inc. · Dec 1994