Cleared Traditional

K842664 - ANTI-TOXOPLASMA GONDII KIT

K842664 is an FDA 510(k) clearance for ANTI-TOXOPLASMA GONDII KIT, manufactured by Amico Lab, Inc.. The device is a Class 2 Immunology device with product code GLZ cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K842664 · Amico Lab, Inc. · Immunology device
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Aug 1984
Decision
49d
Days
Class 2
Risk

K842664 is an FDA 510(k) clearance for the ANTI-TOXOPLASMA GONDII KIT. Classified as Antigens, If, Toxoplasma Gondii (product code GLZ), Class II - Special Controls.

Submitted by Amico Lab, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 28, 1984 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3780 - the FDA immunology 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 - K842664

510(k) Number K842664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1984
Decision Date August 28, 1984
Days to Decision 49 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 105d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GLZ Device Classification - Class 2, Special Controls

Product Code GLZ Antigens, If, 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 Immunology devices follow this clearance model.

Regulatory Peers - GLZ Antigens, If, Toxoplasma Gondii

All 8
Devices cleared under the same product code (GLZ) and FDA review panel - the closest regulatory comparables to K842664.
TOXOPLASMA IGM IFA TEST SYSTEM
K924882 · Zeus Scientific, Inc. · Mar 1993
TOXO IGM TEST
K880007 · Gull Laboratories, Inc. · Mar 1988
FIAX TOXO-M ANTIBODIES TEST KIT
K850591 · Intl. Diagnostic Technology · Apr 1985
TOXOPLASMA ANTIBODY TEST SYSTEM
K791571 · Zeus Scientific, Inc. · Sep 1979
FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO
K790464 · Intl. Diagnostic Technology · Jun 1979
QUANTAZYME TOXOPLASMA
K790360 · Bio-Rad · May 1979