Cleared Traditional

K913787 - TOXOPLASMA IGM ELISA TEST SYSTEM

K913787 is an FDA 510(k) clearance for TOXOPLASMA IGM ELISA TEST SYSTEM, manufactured by Zeus Scientific, Inc.. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K913787 · Zeus Scientific, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
117d
Days
Class 2
Risk

K913787 is an FDA 510(k) clearance for the TOXOPLASMA IGM ELISA TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on December 18, 1991 after a review of 117 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 Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K913787

510(k) Number K913787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1991
Decision Date December 18, 1991
Days to Decision 117 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 102d · This submission: 117d
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 81
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K913787.
ENZYGNOST TOXOPLASMOSIS/IGM
K913505 · Behring Diagnostics, Inc. · Mar 1992
TOXO IGG ELISA TEST (MODIFIED)
K915891 · Gull Laboratories, Inc. · Mar 1992
ELISA TOXO IGM
K914852 · Sclavo, Inc. · Jan 1992
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