Cleared Traditional

K903324 - TOXO IGM ELISA TEST

K903324 is the FDA 510(k) clearance for TOXO IGM ELISA TEST by Gull Laboratories, Inc.. It is a Class 2 Microbiology device (product code LGD) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K903324 · Gull Laboratories, Inc. · Microbiology device
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Oct 1990
Decision
83d
Days
Class 2
Risk

K903324 is an FDA 510(k) clearance for the TOXO IGM ELISA TEST. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 16, 1990 after a review of 83 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

Submission Details

510(k) Number K903324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1990
Decision Date October 16, 1990
Days to Decision 83 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
19d faster than avg
Panel avg: 102d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 76
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K903324.
OPUS(R) ROZO
K911834 · Pb Diagnostic Systems, Inc. · Aug 1991
ABBOTT TOXO-M EIA HIGH POSITIVE CONTROL
K910416 · Abbott Laboratories · Feb 1991
TOXO-CUBE
K903968 · Difco Laboratories, Inc. · Dec 1990
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO.
K900818 · Vitek Systems, Inc. · Apr 1990
TOXO IGG ELISA TEST
K900354 · Gull Laboratories, Inc. · Apr 1990
PLATELIA TOXO IGM KIT
K894948 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1990