Cleared Special

K090847 - PLATELIA TOXO IGM KIT MODEL 26211

K090847 is the FDA 510(k) clearance for PLATELIA TOXO IGM KIT MODEL 26211 by Bio-Rad Laboratories. It is a Class 2 Microbiology device (product code LGD) cleared through the Special 510(k) pathway after a 93-day FDA review.

K090847 · Bio-Rad Laboratories · Microbiology device
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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.

View all Bio-Rad Laboratories devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 102d · 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.

Regulatory Peers - LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

All 71
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K090847.
LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II
K131441 · DiaSorin, Inc. · Aug 2013
VIDAS TOXO IGG AVIDITY
K101946 · bioMerieux, Inc. · May 2011
ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)
K102681 · Siemens Healthcare Diagnostics, Inc. · May 2011
ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG
K073501 · Roche Diagnostics Corp. · Jun 2008
ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC
K080869 · Beckman Coulter, Inc. · May 2008
ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY
K032162 · Beckman Coulter, Inc. · Aug 2003