Cleared Traditional

K911496 - FASTTECH SYSTEM 1

K911496 is an FDA 510(k) clearance for FASTTECH SYSTEM 1, manufactured by 3M Diagnostic Systems, Inc.. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K911496 · 3M Diagnostic Systems, Inc. · Microbiology device
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Jun 1991
Decision
81d
Days
Class 2
Risk

K911496 is an FDA 510(k) clearance for the FASTTECH SYSTEM 1. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by 3M Diagnostic Systems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on June 24, 1991 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3830 - the FDA microbiology 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 - K911496

510(k) Number K911496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1991
Decision Date June 24, 1991
Days to Decision 81 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 102d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LSR Device Classification - Class 2, Special Controls

Product Code LSR Reagent, Borrelia Serological Reagent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3830
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 Microbiology devices follow this clearance model.

Regulatory Peers - LSR Reagent, Borrelia Serological Reagent

All 98
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K911496.
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K903013 · Gull Laboratories, Inc. · Jun 1991
LYME DISEASE MICROASSAY
K910899 · Diamedix Corp. · Jun 1991
LYME IGM MICROASSAY
K911330 · Diamedix Corp. · Jun 1991