Cleared Traditional

K844629 - MAST LUMINESCENT ALLERGY SYSTEM

K844629 is the FDA 510(k) clearance for MAST LUMINESCENT ALLERGY SYSTEM by Mast Immunosystems. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K844629 · Mast Immunosystems · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
136d
Days
Class 2
Risk

K844629 is an FDA 510(k) clearance for the MAST LUMINESCENT ALLERGY SYSTEM. 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 12, 1985 after a review of 136 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 Mast Immunosystems devices

Submission Details

510(k) Number K844629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1984
Decision Date April 12, 1985
Days to Decision 136 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 104d · This submission: 136d
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 K844629.
PHADEBAS RAST TEST ALLERGEN DISCS
K852189 · Pharmacia, Inc. · Jul 1985
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES
K852263 · Pharmacia, Inc. · Jun 1985
PHADEBAS RAST PHADEZYM RAST ALLERTUBES
K851273 · Pharmacia, Inc. · May 1985
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS
K845032 · Pharmacia, Inc. · Mar 1985
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE
K842457 · Pharmacia, Inc. · Jul 1984
VENTRESCREEN, MULTIPLE ALLERGEN DISCS
K841516 · Ventrex Laboratories, Inc. · May 1984