Cleared Traditional

K903968 - TOXO-CUBE

K903968 is an FDA 510(k) clearance for TOXO-CUBE, manufactured by Difco Laboratories, Inc.. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K903968 · Difco Laboratories, Inc. · Microbiology device
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Dec 1990
Decision
112d
Days
Class 2
Risk

K903968 is an FDA 510(k) clearance for the TOXO-CUBE. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Difco Laboratories, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on December 18, 1990 after a review of 112 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Difco Laboratories, Inc. devices

FDA 510(k) Submission Details - K903968

510(k) Number K903968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1990
Decision Date December 18, 1990
Days to Decision 112 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
10d slower than avg
Panel avg: 102d · This submission: 112d
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 K903968.
ABBOTT IMX TOXO IGM POSITIVE CONTROL
K913106 · Abbott Laboratories · Nov 1991
OPUS(R) ROZO
K911834 · Pb Diagnostic Systems, Inc. · Aug 1991
ABBOTT TOXO-M EIA HIGH POSITIVE CONTROL
K910416 · Abbott Laboratories · Feb 1991
TOXO IGM ELISA TEST
K903324 · Gull Laboratories, Inc. · Oct 1990
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO.
K900818 · Vitek Systems, Inc. · Apr 1990
TOXO IGG ELISA TEST
K900354 · Gull Laboratories, Inc. · Apr 1990