Cleared Special

K031506 - ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY

K031506 is an FDA 510(k) clearance for ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Microbiology device with product code LGD cleared through the Special 510(k) pathway after a 19-day FDA review.

K031506 · Beckman Coulter, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
19d
Days
Class 2
Risk

K031506 is an FDA 510(k) clearance for the ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on June 2, 2003 after a review of 19 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K031506

510(k) Number K031506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2003
Decision Date June 02, 2003
Days to Decision 19 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 102d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

LGD Device Classification - Class 2, Special Controls

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 K031506.
ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC
K080869 · Beckman Coulter, Inc. · May 2008
DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS
K052499 · Diasorin S.P.A · Feb 2006
ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY
K032162 · Beckman Coulter, Inc. · Aug 2003
BIO-RAD PLATELIA TOXO IGM TMB
K013837 · Bio-Rad · Sep 2002
BIO-RAD PLATELIA TOXO IGG TMB
K013839 · Bio-Rad · Sep 2002
IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6
K012075 · Diagnostic Products Corp. · Jan 2002
K031506 · ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY
Download PDF FDA Summary Beckman Coulter, Inc.