Cleared Traditional

K955799 - COPALIS CMV TOTAL ANTIBODY ASSAY

K955799 is an FDA 510(k) clearance for COPALIS CMV TOTAL ANTIBODY ASSAY, manufactured by Sienna Biotech, Inc.. The device is a Class 2 Microbiology device with product code LJO cleared through the Traditional 510(k) pathway after a 201-day FDA review.

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

FDA 510(k) Submission Details - K955799

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
Combination Product No
PCCP Authorized No
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.

LJO Device Classification - Class 2, Special Controls

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 8
Devices cleared under the same product code (LJO) and FDA review panel - the closest regulatory comparables to K955799.
HYBRID CAPTURE SYSTEM CMV DNA ASSAY
K974901 · Digene Corp. · Sep 1998
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-IHA
K852494 · Hillcrest Biologicals · Sep 1985
CMV LATEX AGGLUTINATION TEST KIT
K841520 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1984