Cleared Traditional

K012075 - IMMULITE TOXOPLASMA IGM

K012075 is the FDA 510(k) clearance for IMMULITE TOXOPLASMA IGM by Diagnostic Products Corp.. It is a Class 2 Microbiology device (product code LGD) cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K012075 · Diagnostic Products Corp. · Microbiology device
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Jan 2002
Decision
192d
Days
Class 2
Risk

K012075 is an FDA 510(k) clearance for the IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM,.... Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on January 10, 2002 after a review of 192 days - an extended review cycle.

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. Standard predicate reliance. 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K012075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2001
Decision Date January 10, 2002
Days to Decision 192 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
90d slower than avg
Panel avg: 102d · This submission: 192d
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 73
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K012075.
ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY
K031506 · Beckman Coulter, Inc. · Jun 2003
BIO-RAD PLATELIA TOXO IGM TMB
K013837 · Bio-Rad · Sep 2002
BIO-RAD PLATELIA TOXO IGG TMB
K013839 · Bio-Rad · Sep 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
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479
K002453 · Beckman Coulter, Inc. · Aug 2000