Cleared Special

PLATELIA TOXO IGM KIT MODEL 26211 (K090847) - 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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 105
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K090847.
Access Toxo IgG
K242022 · Beckman Coulter, Inc. · Mar 2025
Access Toxo IgM II
K242095 · Beckman Coulter, Inc. · Oct 2024
Alinity i Toxo IgM
K233932 · Abbott Laboratories · Aug 2024
ARCHITECT Toxo IgG
K210596 · Abbott Laboratories · May 2022
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
K162678 · Roche Diagnostics · Jun 2017
AXSYM TOXO IGM
K954576 · Abbott Laboratories · Aug 1996