Cleared Traditional

K896852 - VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY

K896852 is the FDA 510(k) clearance for VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY by Ventrex Laboratories, Inc.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K896852 · Ventrex Laboratories, Inc. · Immunology device
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Dec 1989
Decision
13d
Days
Class 2
Risk

K896852 is an FDA 510(k) clearance for the VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY. 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 December 18, 1989 after a review of 13 days - a notably fast clearance 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: 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 K896852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1989
Decision Date December 18, 1989
Days to Decision 13 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
91d faster than avg
Panel avg: 104d · This submission: 13d
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 K896852.
PHARMACIA CAP SYSTEM RAST RIA & RAST FEIA
K894190 · Pharmacia, Inc. · Jan 1990
ENZYMUN TEST R IGE
K896902 · Boehringer Mannheim Corp. · Jan 1990
3M MULTI-ALLERGEN IGE FASTSCREEN S7, (G3,4,5,6,8)
K897145 · 3M Company · Jan 1990
VENTREZYME VAST SPECIFIC IGE ASSAY
K896694 · Ventrex Laboratories, Inc. · Dec 1989
CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY
K896592 · Ciba Corning Diagnostics Corp. · Dec 1989
QUIDEL FOOD ALLERGEN SCREEN
K894253 · Quidel Corp. · Jul 1989