Cleared Traditional

K931334 - VIDAS TOXO COMPETITION (TXC) ASSAY

K931334 is an FDA 510(k) clearance for VIDAS TOXO COMPETITION (TXC) ASSAY, manufactured by Biomerieux Vitek, Inc.. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K931334 · Biomerieux Vitek, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
97d
Days
Class 2
Risk

K931334 is an FDA 510(k) clearance for the VIDAS TOXO COMPETITION (TXC) ASSAY. 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 June 21, 1993 after a review of 97 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 Biomerieux Vitek, Inc. devices

FDA 510(k) Submission Details - K931334

510(k) Number K931334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1993
Decision Date June 21, 1993
Days to Decision 97 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
5d faster than avg
Panel avg: 102d · This submission: 97d
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 94
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K931334.
ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM
K951495 · Bio-Rad Laboratories, Inc. · Dec 1995
IMX TOXO IGG
K951636 · Abbott Laboratories · Aug 1995
IMX(R) TOXO IGM
K945634 · Abbott Laboratories · Apr 1995
VIDAS TOXO IG6 ASSAY (TX6)
K922737 · Biomerieux Vitek, Inc. · May 1993
VIDAS TOXOPLASMA GONDII IGM ASSSAY
K923166 · Biomerieux Vitek, Inc. · Feb 1993
BARTELS TOXOPLASMA IGM EIA
K922579 · Baxter Diagnostics, Inc. · Sep 1992