Cleared Traditional

ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479 (K003259) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K003259 · Beckman Coulter, Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
Jun 2001
Decision
238d
Days
Class 2
Risk

K003259 is an FDA 510(k) clearance for the ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL .... 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 13, 2001 after a review of 238 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K003259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2000
Decision Date June 13, 2001
Days to Decision 238 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
136d slower than avg
Panel avg: 102d · This submission: 238d
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 105
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