Cleared Traditional

K880007 - TOXO IGM TEST

K880007 is an FDA 510(k) clearance for TOXO IGM TEST, manufactured by Gull Laboratories, Inc.. The device is a Class 2 Microbiology device with product code GLZ cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K880007 · Gull Laboratories, Inc. · Microbiology device
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Mar 1988
Decision
73d
Days
Class 2
Risk

K880007 is an FDA 510(k) clearance for the TOXO IGM TEST. Classified as Antigens, If, Toxoplasma Gondii (product code GLZ), Class II - Special Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 17, 1988 after a review of 73 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 Gull Laboratories, Inc. devices

FDA 510(k) Submission Details - K880007

510(k) Number K880007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1988
Decision Date March 17, 1988
Days to Decision 73 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
29d faster than avg
Panel avg: 102d · This submission: 73d
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 Microbiology 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 K880007.
TOXOPLASMA IGM IFA TEST SYSTEM
K924882 · Zeus Scientific, Inc. · Mar 1993
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