Cleared Traditional

K842528 - AMIZYME-TOXOPLASMA GONDII KIT

K842528 is an FDA 510(k) clearance for AMIZYME-TOXOPLASMA GONDII KIT, manufactured by Amico Lab, Inc.. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K842528 · Amico Lab, Inc. · Microbiology device
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Sep 1984
Decision
71d
Days
Class 2
Risk

K842528 is an FDA 510(k) clearance for the AMIZYME-TOXOPLASMA GONDII KIT. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Amico Lab, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1984 after a review of 71 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 Amico Lab, Inc. devices

FDA 510(k) Submission Details - K842528

510(k) Number K842528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1984
Decision Date September 07, 1984
Days to Decision 71 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
31d faster than avg
Panel avg: 102d · This submission: 71d
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 K842528.
ABBOTT TOXO-M EIA DIAGNOSTIC KIT
K850567 · Abbott Laboratories · Jul 1985
CORDIA T-M
K843417 · Cordis Corp. · Jan 1985
TOXOPLASMA GONDII IGM EIA TEST KIT
K842797 · Labsystems, Inc. · Oct 1984
TOXO-G EIA DIAGNOSTIC KIT
K840879 · Abbott Laboratories · May 1984
TOXOPLASMA GOND II IGG DIA TEST KIT
K833829 · Labsystems, Inc. · Apr 1984