Cleared Traditional

K914852 - ELISA TOXO IGM

K914852 is the FDA 510(k) clearance for ELISA TOXO IGM by Sclavo, Inc.. It is a Class 2 Microbiology device (product code LGD) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K914852 · Sclavo, Inc. · Microbiology device
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Jan 1992
Decision
87d
Days
Class 2
Risk

K914852 is an FDA 510(k) clearance for the ELISA TOXO IGM. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on January 23, 1992 after a review of 87 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 Sclavo, Inc. devices

Submission Details

510(k) Number K914852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1991
Decision Date January 23, 1992
Days to Decision 87 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 faster than avg
Panel avg: 102d · This submission: 87d
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 K914852.
ENZYGNOST(R) TOXOPLASMOSIS/IGG
K913731 · Behring Diagnostics, Inc. · Apr 1992
ENZYGNOST TOXOPLASMOSIS/IGM
K913505 · Behring Diagnostics, Inc. · Mar 1992
TOXO IGG ELISA TEST (MODIFIED)
K915891 · Gull Laboratories, Inc. · Mar 1992
TOXOPLASMA IGM ELISA TEST SYSTEM
K913787 · Zeus Scientific, Inc. · Dec 1991
ABBOTT IMX TOXO IGM POSITIVE CONTROL
K913106 · Abbott Laboratories · Nov 1991
OPUS(R) ROZO
K911834 · Pb Diagnostic Systems, Inc. · Aug 1991