Cleared Traditional

AXSYM TOXO IGM (K954576) - 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.

View all Abbott Laboratories devices

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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

All 44
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K954576.
ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469
K973448 · Beckman Instruments, Inc. · Sep 1998
QUANTA LITE TOXOPLASMA IGG
K971441 · Inova Diagnostics, Inc. · Dec 1997
IMMULITE TOXOPLASMA QUANTITATIVE IGG
K962936 · Diagnostic Products Corp. · Apr 1997
AXSYM TOXO IGG ANTIBODY ASSAY
K954575 · Abbott Laboratories · Aug 1996
IMMULITE TOXOPLASMA GONDII IGG
K950671 · Diagnostic Products Corp. · Feb 1996
IMX TOXO IGG
K951636 · Abbott Laboratories · Aug 1995