Cleared Traditional

K914554 - SPECIFIC IGE EIA-TURBO ASSAY

K914554 is an FDA 510(k) clearance for SPECIFIC IGE EIA-TURBO ASSAY, manufactured by Ventrex Laboratories, Inc.. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K914554 · Ventrex Laboratories, Inc. · Immunology device
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Mar 1992
Decision
154d
Days
Class 2
Risk

K914554 is an FDA 510(k) clearance for the SPECIFIC IGE EIA-TURBO 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 March 13, 1992 after a review of 154 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

FDA 510(k) Submission Details - K914554

510(k) Number K914554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1991
Decision Date March 13, 1992
Days to Decision 154 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 105d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHB Device Classification - Class 2, Special Controls

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 231
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K914554.
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
K914959 · Ciba Corning Diagnostics Corp. · Aug 1992
WHITE ASH - FRAXINUS AMERICANA (T15) ALLERGEN DISC
K921574 · Hycor Biomedical, Inc. · Aug 1992
VENTREX ALLERGEN DISC
K922538 · Hycor Biomedical, Inc. · Jul 1992
VENTREX ALLERGEN DISC
K913833 · Ventrex Laboratories, Inc. · Feb 1992
ABBOTT MATRIX AERO PLUS SYSTEM
K913150 · Abbott Laboratories · Nov 1991
ALLERGY INFORMATION MANAGER
K912294 · Diagnostic Products Corp. · Nov 1991