Cleared Traditional

K092587 - BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM (FDA 510(k) Clearance)

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

K092587 · Bio-Rad Laboratories · Microbiology device
Dec 2010
Decision
466d
Days
Class 2
Risk

K092587 is an FDA 510(k) clearance for the BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTIO.... Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Bio-Rad Laboratories (Benicia, US). The FDA issued a Cleared decision on December 3, 2010 after a review of 466 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.

Submission Details

510(k) Number K092587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2009
Decision Date December 03, 2010
Days to Decision 466 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
292d slower than avg
Panel avg: 174d · This submission: 466d
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.