Cleared Traditional

K922737 - VIDAS TOXO IG6 ASSAY (TX6)

K922737 is an FDA 510(k) clearance for VIDAS TOXO IG6 ASSAY (TX6), 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 337-day FDA review.

K922737 · Biomerieux Vitek, Inc. · Microbiology device
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May 1993
Decision
337d
Days
Class 2
Risk

K922737 is an FDA 510(k) clearance for the VIDAS TOXO IG6 ASSAY (TX6). Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on May 11, 1993 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K922737

510(k) Number K922737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1992
Decision Date May 11, 1993
Days to Decision 337 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
235d slower than avg
Panel avg: 102d · This submission: 337d
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 K922737.
IMX TOXO IGG
K951636 · Abbott Laboratories · Aug 1995
IMX(R) TOXO IGM
K945634 · Abbott Laboratories · Apr 1995
VIDAS TOXO COMPETITION (TXC) ASSAY
K931334 · Biomerieux Vitek, Inc. · Jun 1993
VIDAS TOXOPLASMA GONDII IGM ASSSAY
K923166 · Biomerieux Vitek, Inc. · Feb 1993
BARTELS TOXOPLASMA IGM EIA
K922579 · Baxter Diagnostics, Inc. · Sep 1992
BARTELS TOXOPLASMA IGG EIA
K922585 · Baxter Diagnostics, Inc. · Sep 1992