Cleared Traditional

K010755 - BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY

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

K010755 · Bayer Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K010755

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.

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 94
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K010755.
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
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY
K012183 · Bayer Diagnostics Corp. · Dec 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
DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM
K001707 · Diamedix Corp. · Jul 2000