Cleared Traditional

K870966 - TOTAL IGE MASTICK

K870966 is the FDA 510(k) clearance for TOTAL IGE MASTICK by Mast Immunosystems. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K870966 · Mast Immunosystems · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1987
Decision
35d
Days
Class 2
Risk

K870966 is an FDA 510(k) clearance for the TOTAL IGE MASTICK. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Mast Immunosystems (Mountain View, US). The FDA issued a Cleared decision on April 14, 1987 after a review of 35 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 Mast Immunosystems devices

Submission Details

510(k) Number K870966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1987
Decision Date April 14, 1987
Days to Decision 35 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 104d · This submission: 35d
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 200
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K870966.
WESTERN RAGWEED ALLERGEN DISC
K871660 · Incstar Corp. · May 1987
VENTRESCREEN CAT/DOG ALLERGY TEST KIT ENZYME IMMU.
K871331 · Ventrex Laboratories, Inc. · Apr 1987
VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM.
K870009 · 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