Cleared Special

K090847 - PLATELIA TOXO IGM KIT MODEL 26211 (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K090847 · Bio-Rad Laboratories · Microbiology device
Jul 2009
Decision
93d
Days
Class 2
Risk

K090847 is an FDA 510(k) clearance for the PLATELIA TOXO IGM KIT MODEL 26211. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Bio-Rad Laboratories (Redmond, US). The FDA issued a Cleared decision on July 1, 2009 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3780 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K090847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2009
Decision Date July 01, 2009
Days to Decision 93 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 174d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3780
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.