Cleared Traditional

ABBOTT TOXO-M EIA HIGH POSITIVE CONTROL (K910416) - FDA 510(k) Clearance

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

K910416 · Abbott Laboratories · Microbiology device
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Feb 1991
Decision
27d
Days
Class 2
Risk

K910416 is an FDA 510(k) clearance for the ABBOTT TOXO-M EIA HIGH POSITIVE CONTROL. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 26, 1991 after a review of 27 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Laboratories devices

Submission Details

510(k) Number K910416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1991
Decision Date February 26, 1991
Days to Decision 27 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 102d · This submission: 27d
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 K910416.
ENZYGNOST TOXOPLASMOSIS/IGM
K913505 · Behring Diagnostics, Inc. · Mar 1992
TOXOPLASMA IGM ELISA TEST SYSTEM
K913787 · Zeus Scientific, Inc. · Dec 1991
ABBOTT IMX TOXO IGM POSITIVE CONTROL
K913106 · Abbott Laboratories · Nov 1991
TOXO-CUBE
K903968 · Difco Laboratories, Inc. · Dec 1990
TOXO ELISA TEST SYSTEM
K891781 · Zeus Scientific, Inc. · Jul 1989
IMX TOXO IGG ANTIBODY ASSAY
K890031 · Abbott Laboratories · Jun 1989