Cleared Traditional

K993319 - VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210

K993319 is the FDA 510(k) clearance for VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 by bioMerieux, Inc.. It is a Class 2 Microbiology device (product code LGD) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K993319 · bioMerieux, Inc. · Microbiology device
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May 2000
Decision
231d
Days
Class 2
Risk

K993319 is an FDA 510(k) clearance for the VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Rockland, US). The FDA issued a Cleared decision on May 22, 2000 after a review of 231 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, Inc. devices

Submission Details

510(k) Number K993319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1999
Decision Date May 22, 2000
Days to Decision 231 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
129d slower than avg
Panel avg: 102d · This submission: 231d
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 K993319.
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479
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ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479
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DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM
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THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F
K984317 · Zeus Scientific, Inc. · Jan 1999
THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TEST SYSTEM
K984170 · Zeus Scientific, Inc. · Jan 1999
ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469
K973448 · Beckman Instruments, Inc. · Sep 1998