Cleared Traditional

K954576 - AXSYM TOXO IGM

K954576 is an FDA 510(k) clearance for AXSYM TOXO IGM, manufactured by Abbott Laboratories. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K954576 · Abbott Laboratories · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K954576

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.

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 83
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K954576.
TOXO IGG ELISA TEST
K962343 · Gull Laboratories, Inc. · Mar 1997
INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)
K963296 · Incstar Corp. · Dec 1996
INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)
K963297 · Incstar Corp. · Dec 1996
AXSYM TOXO IGG ANTIBODY ASSAY
K954575 · Abbott Laboratories · Aug 1996
TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM
K955760 · Bayer Corp. · Aug 1996
SERAQUEST TOXOPLASMA IGG
K960092 · Quest Intl., Inc. · Jun 1996