Cleared Traditional

K931224 - VIDAS TOTAL IGE (IGE) ASSAY

K931224 is an FDA 510(k) clearance for VIDAS TOTAL IGE (IGE) ASSAY, manufactured by Biomerieux Vitek, Inc.. The device is a Class 2 Immunology device with product code DGP cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K931224 · Biomerieux Vitek, Inc. · Immunology device
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May 1993
Decision
71d
Days
Class 2
Risk

K931224 is an FDA 510(k) clearance for the VIDAS TOTAL IGE (IGE) ASSAY. Classified as Ige, Fitc, Antigen, Antiserum, Control (product code DGP), Class II - Special Controls.

Submitted by Biomerieux Vitek, Inc. (Rockland, US). The FDA issued a Cleared decision on May 20, 1993 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology 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 Biomerieux Vitek, Inc. devices

FDA 510(k) Submission Details - K931224

510(k) Number K931224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1993
Decision Date May 20, 1993
Days to Decision 71 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 105d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DGP Device Classification - Class 2, Special Controls

Product Code DGP Ige, Fitc, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 Immunology devices follow this clearance model.