Cleared Traditional

K861282 - MUREX SUDS RUBELLA

K861282 is an FDA 510(k) clearance for MUREX SUDS RUBELLA, manufactured by Murex Corp.. The device is a Class 2 Microbiology device with product code LFX cleared through the Traditional 510(k) pathway after a 67-day FDA review.

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

FDA 510(k) Submission Details - K861282

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.

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 80
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K861282.
RUBELLA IGM EIA TEST KIT
K862431 · Labsystems, Inc. · Aug 1986
RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540
K860145 · Clinical Sciences, Inc. · Jul 1986
RUBELLA IGG EIA TEST KIT
K853696 · Labsystems, Inc. · Jun 1986
CORDOT R
K854618 · Cordis Corp. · May 1986
TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT
K853069 · Hybritech, Inc. · Jan 1986
RUBELLA IGG ANTIBODY ELISA TEST SYS
K841200 · Ortho Diagnostic Systems, Inc. · May 1984