Cleared Traditional

COPALIS CMV TOTAL ANTIBODY ASSAY (K955799) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K955799 · Sienna Biotech, Inc. · Microbiology device
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Jul 1996
Decision
201d
Days
Class 2
Risk

K955799 is an FDA 510(k) clearance for the COPALIS CMV TOTAL ANTIBODY ASSAY. Classified as Antigen, Iha, Cytomegalovirus (product code LJO), Class II - Special Controls.

Submitted by Sienna Biotech, Inc. (Bethesda, US). The FDA issued a Cleared decision on July 10, 1996 after a review of 201 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3175 - 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 Sienna Biotech, Inc. devices

Submission Details

510(k) Number K955799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1995
Decision Date July 10, 1996
Days to Decision 201 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
99d slower than avg
Panel avg: 102d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJO Antigen, Iha, Cytomegalovirus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3175
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LJO Antigen, Iha, Cytomegalovirus

All 11
Devices cleared under the same product code (LJO) and FDA review panel - the closest regulatory comparables to K955799.
Capture-CMV
K203612 · Immucor, Inc. · Mar 2021
Capture-CMV
K183571 · Immucor, Inc. · Feb 2019
CMVGEN
K974456 · Instrumentation Laboratory CO · May 1998
ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY
K951851 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1996
CMV LATEX AGGLUTINATION TEST KIT
K841520 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1984