Cleared Traditional

K832900 - IMMUNOENZYME TEST SYS-DETECT-IGM ANTI

K832900 is the FDA 510(k) clearance for IMMUNOENZYME TEST SYS-DETECT-IGM ANTI by Bionetic Laboratory Products. It is a Class 2 Immunology device (product code GLZ) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K832900 · Bionetic Laboratory Products · Immunology device
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Nov 1983
Decision
77d
Days
Class 2
Risk

K832900 is an FDA 510(k) clearance for the IMMUNOENZYME TEST SYS-DETECT-IGM ANTI. Classified as Antigens, If, Toxoplasma Gondii (product code GLZ), Class II - Special Controls.

Submitted by Bionetic Laboratory Products (Mchenry, US). The FDA issued a Cleared decision on November 14, 1983 after a review of 77 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 Bionetic Laboratory Products devices

Submission Details

510(k) Number K832900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1983
Decision Date November 14, 1983
Days to Decision 77 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 104d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 9
Devices cleared under the same product code (GLZ) and FDA review panel - the closest regulatory comparables to K832900.
TOXO IGM TEST
K880007 · Gull Laboratories, Inc. · Mar 1988
FIAX TOXO-M ANTIBODIES TEST KIT
K850591 · Intl. Diagnostic Technology · Apr 1985
ANTI-TOXOPLASMA GONDII KIT
K842664 · Amico Lab, Inc. · Aug 1984
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