Cleared Traditional

K993291 - COPALIS RUBELLA IGM

K993291 is an FDA 510(k) clearance for COPALIS RUBELLA IGM, manufactured by DiaSorin, Inc.. The device is a Class 2 Microbiology device with product code LFX cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K993291 · DiaSorin, Inc. · Microbiology device
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Feb 2000
Decision
132d
Days
Class 2
Risk

K993291 is an FDA 510(k) clearance for the COPALIS RUBELLA IGM. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by DiaSorin, Inc. (Columbia, US). The FDA issued a Cleared decision on February 10, 2000 after a review of 132 days - within the typical 510(k) review window.

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 DiaSorin, Inc. devices

FDA 510(k) Submission Details - K993291

510(k) Number K993291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1999
Decision Date February 10, 2000
Days to Decision 132 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
30d slower than avg
Panel avg: 102d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFX Device Classification - Class 2, Special Controls

Product Code LFX Enzyme Linked Immunoabsorbent 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 - LFX Enzyme Linked Immunoabsorbent Assay, Rubella

All 79
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K993291.
BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY
K010668 · Bayer Corp. · Jul 2001
ADVIA CENTAUR RUBELLA IGG ASSAY
K003412 · Bayer Corp. · Apr 2001
DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM
K001875 · Diamedix Corp. · Aug 2000
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM
K984180 · Zeus Scientific, Inc. · Jul 1999
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
K983805 · Zeus Scientific, Inc. · May 1999
IS-RUBELLA IGG TEST SYSTEM
K981729 · Diamedix Corp. · Jan 1999