Cleared Traditional

K913892 - FASTTECH SYSTEM II

K913892 is an FDA 510(k) clearance for FASTTECH SYSTEM II, manufactured by 3M Diagnostic Systems, Inc.. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K913892 · 3M Diagnostic Systems, Inc. · Immunology device
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Oct 1991
Decision
33d
Days
Class 2
Risk

K913892 is an FDA 510(k) clearance for the FASTTECH SYSTEM II. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by 3M Diagnostic Systems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on October 2, 1991 after a review of 33 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 3M Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K913892

510(k) Number K913892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1991
Decision Date October 02, 1991
Days to Decision 33 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 105d · This submission: 33d
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 232
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K913892.
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K912582 · Ciba Corning Diagnostics Corp. · Jul 1991
ALLERGEN MODULES FOR ALASTAT TM
K894227 · Diagnostic Products Corp. · Apr 1991