Cleared Traditional

K863813 - TOXOPLASMA IGG MICROASSAY

K863813 is the FDA 510(k) clearance for TOXOPLASMA IGG MICROASSAY by Diamedix Corp.. It is a Class 2 Microbiology device (product code LGD) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K863813 · Diamedix Corp. · Microbiology device
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Nov 1986
Decision
59d
Days
Class 2
Risk

K863813 is an FDA 510(k) clearance for the TOXOPLASMA IGG MICROASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on November 28, 1986 after a review of 59 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 Diamedix Corp. devices

Submission Details

510(k) Number K863813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1986
Decision Date November 28, 1986
Days to Decision 59 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
43d faster than avg
Panel avg: 102d · This submission: 59d
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 73
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K863813.
DETECTADOT SYSTEM 2000 TOXO IGG TEST
K875109 · Gull Laboratories, Inc. · Mar 1988
TOXOPLASMA IGM MICROASSAY
K870753 · Diamedix Corp. · Apr 1987
ACCUPOINT TOXO
K865068 · Syva Co. · Feb 1987
TOXONOSTIKA IGM MICROELISA SYSTEM
K862196 · Organon Teknika Corp. · Sep 1986
ORGANON TEKNIKA TOXONOSTIKA IGG MICROELISA SYSTEM
K862189 · Organon Teknika Corp. · Sep 1986
ABBOTT TOXO-M EIA DIAGNOSTIC KIT
K850567 · Abbott Laboratories · Jul 1985