Cleared Traditional

K954576 - AXSYM TOXO IGM (FDA 510(k) Clearance)

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

K954576 · Abbott Laboratories · Microbiology device
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Aug 1996
Decision
326d
Days
Class 2
Risk

K954576 is an FDA 510(k) clearance for the AXSYM TOXO IGM. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Abbott Laboratories (Buffalo, US). The FDA issued a Cleared decision on August 23, 1996 after a review of 326 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.

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Submission Details

510(k) Number K954576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1995
Decision Date August 23, 1996
Days to Decision 326 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
224d slower than avg
Panel avg: 102d · This submission: 326d
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.