Cleared Traditional

K010755 - BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLA...

K010755 is the FDA 510(k) clearance for BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLA... by Bayer Corp.. It is a Class 2 Microbiology device (product code LGD) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K010755 · Bayer Corp. · Microbiology device
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Aug 2001
Decision
160d
Days
Class 2
Risk

K010755 is an FDA 510(k) clearance for the BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Bayer Corp. (Medfield, US). The FDA issued a Cleared decision on August 20, 2001 after a review of 160 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 Bayer Corp. devices

Submission Details

510(k) Number K010755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2001
Decision Date August 20, 2001
Days to Decision 160 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
58d slower than avg
Panel avg: 102d · This submission: 160d
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 K010755.
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
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
DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM
K001707 · Diamedix Corp. · Jul 2000