Cleared Traditional

IMX RUBELLA IGM ANTIBODY ASSAY (K931059) - FDA 510(k) Clearance

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

K931059 · Abbott Laboratories · Microbiology device
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Dec 1994
Decision
658d
Days
Class 2
Risk

K931059 is an FDA 510(k) clearance for the IMX RUBELLA IGM ANTIBODY ASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 19, 1994 after a review of 658 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Abbott Laboratories devices

Submission Details

510(k) Number K931059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1993
Decision Date December 19, 1994
Days to Decision 658 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
556d slower than avg
Panel avg: 102d · This submission: 658d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 31
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K931059.
AXSYM RUBELLA IGG ANTIBODY ASSAY
K954045 · Abbott Laboratories · Sep 1996
IMX RUBELLA IGG
K951541 · Abbott Laboratories · Jul 1996
ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY
K954318 · Abbott Laboratories · May 1996
RUBELLA IGM ELISA TEST SYSTEM
K914028 · Zeus Scientific, Inc. · Apr 1992
RUBENOSTIKA IGG MICROELISA SYSTEM
K911393 · Organon Teknika Corp. · Apr 1991
ORTHO RUBELLA-M ANTIBODY ELISA TEST
K905079 · Ortho Diagnostic Systems, Inc. · Dec 1990