Cleared Traditional

K013839 - BIO-RAD PLATELIA TOXO IGG TMB

K013839 is the FDA 510(k) clearance for BIO-RAD PLATELIA TOXO IGG TMB by Bio-Rad. It is a Class 2 Microbiology device (product code LGD) cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K013839 · Bio-Rad · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
315d
Days
Class 2
Risk

K013839 is an FDA 510(k) clearance for the BIO-RAD PLATELIA TOXO IGG TMB. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Bio-Rad (Redmond, US). The FDA issued a Cleared decision on September 30, 2002 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3780 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bio-Rad devices

Submission Details

510(k) Number K013839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2001
Decision Date September 30, 2002
Days to Decision 315 days
Submission Type Traditional
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
213d slower than avg
Panel avg: 102d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 76
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K013839.
ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY
K032162 · Beckman Coulter, Inc. · Aug 2003
ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY
K031506 · Beckman Coulter, Inc. · Jun 2003
BIO-RAD PLATELIA TOXO IGM TMB
K013837 · 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
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY
K010755 · Bayer Corp. · Aug 2001
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479
K003259 · Beckman Coulter, Inc. · Jun 2001