Cleared Traditional

MUREX SUDS RUBELLA (K861282) - FDA 510(k) Clearance

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

K861282 · Murex Corp. · Microbiology device
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Jun 1986
Decision
67d
Days
Class 2
Risk

K861282 is an FDA 510(k) clearance for the MUREX SUDS RUBELLA. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Murex Corp. (Norcross, US). The FDA issued a Cleared decision on June 13, 1986 after a review of 67 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Murex Corp. devices

Submission Details

510(k) Number K861282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1986
Decision Date June 13, 1986
Days to Decision 67 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 102d · This submission: 67d
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 93
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K861282.
Access Rubella IgG
K250588 · Beckman Coulter, Inc. · Nov 2025
Alinity i Rubella IgG
K243168 · Abbott Laboratories · Jun 2025
ELECSYS RUBELLA IGM IMMUNOASSAY
K092322 · Roche Diagnostics · Mar 2010
VIDAS RUB IGG
K080766 · bioMerieux, Inc. · Dec 2008
ELECSYS RUBELLA IGG IMMUNOASSAY
K072617 · Roche Diagnostics Corp. · Dec 2008
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
K031606 · Beckman Coulter, Inc. · Jun 2003