Cleared Traditional

K862216 - TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)

K862216 is an FDA 510(k) clearance for TOXOPLASMA GONDII IGG EIA TEST KIT (AME..., manufactured by Labsystems, Inc.. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K862216 · Labsystems, Inc. · Microbiology device
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Jun 1986
Decision
20d
Days
Class 2
Risk

K862216 is an FDA 510(k) clearance for the TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT). Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Labsystems, Inc. (Morton Grove, US). The FDA issued a Cleared decision on June 30, 1986 after a review of 20 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 Labsystems, Inc. devices

FDA 510(k) Submission Details - K862216

510(k) Number K862216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1986
Decision Date June 30, 1986
Days to Decision 20 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
82d faster than avg
Panel avg: 102d · This submission: 20d
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 95
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K862216.
TOXOPLASMA IGG MICROASSAY
K863813 · Diamedix Corp. · Nov 1986
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
ABBOTT TOXO-M EIA DIAGNOSTIC KIT
K850567 · Abbott Laboratories · Jul 1985
CORDIA T-M
K843417 · Cordis Corp. · Jan 1985