Cleared Traditional

K850895 - VENTREZYME

K850895 is the FDA 510(k) clearance for VENTREZYME by Ventrex Laboratories, Inc.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K850895 · Ventrex Laboratories, Inc. · Immunology device
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Oct 1985
Decision
226d
Days
Class 2
Risk

K850895 is an FDA 510(k) clearance for the VENTREZYME, VAST IMMUNOPEROXIDASE ASSAY. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Ventrex Laboratories, Inc. (Portland, US). The FDA issued a Cleared decision on October 16, 1985 after a review of 226 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ventrex Laboratories, Inc. devices

Submission Details

510(k) Number K850895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1985
Decision Date October 16, 1985
Days to Decision 226 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
122d slower than avg
Panel avg: 104d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHB System, Test, Radioallergosorbent (rast) Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
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 - DHB System, Test, Radioallergosorbent (rast) Immunological

All 199
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K850895.
PHADEBAS RAST PHADEZYM RAST DISCS FX2,FX3 & FX5
K854865 · Pharmacia, Inc. · Apr 1986
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES
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PHADEBAS RAST TEST ALLERGEN DISCS
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ALLERCOAT ALLERGEN DISCS
K852794 · Kallestad Laboratories, Inc. · Sep 1985
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES
K853456 · Pharmacia, Inc. · Sep 1985
PHADEBAS RAST TEST ALLERGEN DISCS
K852189 · Pharmacia, Inc. · Jul 1985