Cleared Traditional

K923166 - VIDAS TOXOPLASMA GONDII IGM ASSSAY

K923166 is the FDA 510(k) clearance for VIDAS TOXOPLASMA GONDII IGM ASSSAY by Biomerieux Vitek, Inc.. It is a Class 2 Microbiology device (product code LGD) cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K923166 · Biomerieux Vitek, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
241d
Days
Class 2
Risk

K923166 is an FDA 510(k) clearance for the VIDAS TOXOPLASMA GONDII IGM ASSSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Biomerieux Vitek, Inc. (Rockland, US). The FDA issued a Cleared decision on February 25, 1993 after a review of 241 days - an extended review 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: 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 Biomerieux Vitek, Inc. devices

Submission Details

510(k) Number K923166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1992
Decision Date February 25, 1993
Days to Decision 241 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 102d · This submission: 241d
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 K923166.
IMX(R) TOXO IGM
K945634 · Abbott Laboratories · Apr 1995
VIDAS TOXO COMPETITION (TXC) ASSAY
K931334 · Biomerieux Vitek, Inc. · Jun 1993
VIDAS TOXO IG6 ASSAY (TX6)
K922737 · Biomerieux Vitek, Inc. · May 1993
BARTELS TOXOPLASMA IGM EIA
K922579 · Baxter Diagnostics, Inc. · Sep 1992
BARTELS TOXOPLASMA IGG EIA
K922585 · Baxter Diagnostics, Inc. · Sep 1992
ENZYGNOST(R) TOXOPLASMOSIS/IGG
K913731 · Behring Diagnostics, Inc. · Apr 1992