Cleared Traditional

K961784 - COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS

K961784 is an FDA 510(k) clearance for COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLAS..., manufactured by Sienna Biotech, Inc.. The device is a Class 2 Microbiology device with product code LQN cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K961784 · Sienna Biotech, Inc. · Microbiology device
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Oct 1996
Decision
182d
Days
Class 2
Risk

K961784 is an FDA 510(k) clearance for the COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY A.... Classified as Latex Agglutination Assay, Rubella (product code LQN), Class II - Special Controls.

Submitted by Sienna Biotech, Inc. (Columbia, US). The FDA issued a Cleared decision on October 31, 1996 after a review of 182 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3510 - 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 - K961784

510(k) Number K961784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1996
Decision Date October 31, 1996
Days to Decision 182 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
80d slower than avg
Panel avg: 102d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LQN Device Classification - Class 2, Special Controls

Product Code LQN Latex Agglutination Assay, Rubella
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3510
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 - LQN Latex Agglutination Assay, Rubella

All 9
Devices cleared under the same product code (LQN) and FDA review panel - the closest regulatory comparables to K961784.
COPALIS TORC TOTAL ANTIBODY ASSAY
K970931 · Sienna Biotech, Inc. · Apr 1997
MUREX RUB-EX
K954920 · Murex Diagnostics, Inc. · Aug 1996
COLORSLIDER RUBELLA
K952544 · Seradyn, Inc. · Jan 1996
RUBALEX, MODIFICATION
K912391 · Orion Corp. · May 1992
RESUBMITTED MODIFIED RUBALEX
K901637 · Orion Corp. · Apr 1990
RUBALEX (REVISED VERSION)
K861881 · Orion Corp. · Jun 1986