Cleared Traditional

K870753 - TOXOPLASMA IGM MICROASSAY

K870753 is an FDA 510(k) clearance for TOXOPLASMA IGM MICROASSAY, manufactured by Diamedix Corp.. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K870753 · Diamedix Corp. · Microbiology device
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Apr 1987
Decision
61d
Days
Class 2
Risk

K870753 is an FDA 510(k) clearance for the TOXOPLASMA IGM 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 April 28, 1987 after a review of 61 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

FDA 510(k) Submission Details - K870753

510(k) Number K870753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1987
Decision Date April 28, 1987
Days to Decision 61 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
41d faster than avg
Panel avg: 102d · This submission: 61d
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 94
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K870753.
CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY
K871746 · Mercia Diagnostics , Ltd. · Jul 1987
TOXOPLASMA GONDII IGG ELISA
K871905 · Electro-Nucleonics Laboratories, Inc. · Jul 1987
MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT
K872252 · Labsystems, Inc. · Jul 1987
ACCUPOINT TOXO
K865068 · Syva Co. · Feb 1987
TOXOPLASMA IGG MICROASSAY
K863813 · Diamedix Corp. · Nov 1986
TOXONOSTIKA IGM MICROELISA SYSTEM
K862196 · Organon Teknika Corp. · Sep 1986