Cleared Traditional

K830817 - NEW ALLERGEN DISCS FOR USE IN VAST VENT

K830817 is an FDA 510(k) clearance for NEW ALLERGEN DISCS FOR USE IN VAST VENT, manufactured by Ventrex Laboratories, Inc.. The device is a Class 2 Immunology device with product code DGC cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K830817 · Ventrex Laboratories, Inc. · Immunology device
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Apr 1983
Decision
43d
Days
Class 2
Risk

K830817 is an FDA 510(k) clearance for the NEW ALLERGEN DISCS FOR USE IN VAST VENT. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Ventrex Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on April 27, 1983 after a review of 43 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 Ventrex Laboratories, Inc. devices

FDA 510(k) Submission Details - K830817

510(k) Number K830817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1983
Decision Date April 27, 1983
Days to Decision 43 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 105d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DGC Device Classification - Class 2, Special Controls

Product Code DGC Ige, 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.

Regulatory Peers - DGC Ige, Antigen, Antiserum, Control

All 90
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K830817.
IGE RADIOIMMUNOASSAY KIT
K831377 · American Diagnostic Corp. · Jun 1983
VENTRE/ZYME IGE KIT
K831485 · Ventrex Laboratories, Inc. · Jun 1983
IGE-QUANT DIAGNOSTIC TEST KIT
K831208 · Leeco Diagnostics, Inc. · May 1983
PHADEBAS RAST ALLERGEN DISCS
K823841 · Pharmacia, Inc. · Jan 1983
PHADEZYM RAST ALLERGEN DISCS
K823842 · Pharmacia, Inc. · Jan 1983
TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY
K823507 · Hybritech, Inc. · Dec 1982