Cleared Traditional

K850567 - ABBOTT TOXO-M EIA DIAGNOSTIC KIT

K850567 is an FDA 510(k) clearance for ABBOTT TOXO-M EIA DIAGNOSTIC KIT, 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 147-day FDA review.

K850567 · Abbott Laboratories · Microbiology device
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Jul 1985
Decision
147d
Days
Class 2
Risk

K850567 is an FDA 510(k) clearance for the ABBOTT TOXO-M EIA DIAGNOSTIC KIT. 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 July 9, 1985 after a review of 147 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K850567

510(k) Number K850567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1985
Decision Date July 09, 1985
Days to Decision 147 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
45d slower than avg
Panel avg: 102d · This submission: 147d
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 K850567.
TOXONOSTIKA IGM MICROELISA SYSTEM
K862196 · Organon Teknika Corp. · Sep 1986
ORGANON TEKNIKA TOXONOSTIKA IGG MICROELISA SYSTEM
K862189 · Organon Teknika Corp. · Sep 1986
TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560
K860773 · Clinical Sciences, Inc. · May 1986
CORDIA T-M
K843417 · Cordis Corp. · Jan 1985
AMIZYME-TOXOPLASMA GONDII KIT
K842528 · Amico Lab, Inc. · Sep 1984
TOXO-G EIA DIAGNOSTIC KIT
K840879 · Abbott Laboratories · May 1984