Cleared Traditional

K870009 - VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM.

K870009 is an FDA 510(k) clearance for VENTRESCREEN MITE/MOLD ALLERGY TEST KIT..., 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 102-day FDA review.

K870009 · Ventrex Laboratories, Inc. · Immunology device
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Apr 1987
Decision
102d
Days
Class 2
Risk

K870009 is an FDA 510(k) clearance for the VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM.. 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 April 14, 1987 after a review of 102 days - within the typical 510(k) review window.

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 - K870009

510(k) Number K870009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1987
Decision Date April 14, 1987
Days to Decision 102 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
3d faster than avg
Panel avg: 105d · This submission: 102d
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 K870009.
DELFIA(TM) HIGE KIT
K871599 · Lkb Instruments, Inc. · Jun 1987
WESTERN RAGWEED ALLERGEN DISC
K871660 · Incstar Corp. · May 1987
VENTRESCREEN CAT/DOG ALLERGY TEST KIT ENZYME IMMU.
K871331 · Ventrex Laboratories, Inc. · Apr 1987
VENTREX IP SPECIFIC E ENZYME IMMUNOASSAY
K870624 · Ventrex Laboratories, Inc. · Mar 1987
D. FARINAE ALLERGEN DISC
K870597 · Incstar Corp. · Mar 1987
CAT EPITHELIUM ALLERGEN DISC
K870264 · Incstar Corp. · Feb 1987