Cleared Traditional

K820897 - VENTRE/SPEC IGE CONTROLS

K820897 is the FDA 510(k) clearance for VENTRE/SPEC IGE CONTROLS by Ventrex Laboratories, Inc.. It is a Class 2 Immunology device (product code DGC) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K820897 · Ventrex Laboratories, Inc. · Immunology device
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May 1982
Decision
36d
Days
Class 2
Risk

K820897 is an FDA 510(k) clearance for the VENTRE/SPEC IGE CONTROLS. 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 May 5, 1982 after a review of 36 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

Submission Details

510(k) Number K820897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1982
Decision Date May 05, 1982
Days to Decision 36 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
68d faster than avg
Panel avg: 104d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 83
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K820897.
VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD
K820977 · Ventrex Laboratories, Inc. · Jun 1982
VENTRE/SPEC ALLERGEN CONTROL-INHALANT
K820978 · Ventrex Laboratories, Inc. · Jun 1982
VAST VENTREX PD IGE RIA TEST SET
K821615 · Ventrex Laboratories, Inc. · Jun 1982
VENTREX 125I ANTI-IGE ALLERGY ISOTOPE
K820896 · Ventrex Laboratories, Inc. · Apr 1982
PHADEBAS/PHADEZYM IGE REAGENTS
K813189 · Pharmacia, Inc. · Dec 1981
VENTRE/SEP IGE RIA TEST SET
K811559 · Ventrex Laboratories, Inc. · Jul 1981