Cleared Traditional

K883544 - LYME FAST TEST

K883544 is the FDA 510(k) clearance for LYME FAST TEST by 3M Company. It is a Class 2 Microbiology device (product code LSR) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K883544 · 3M Company · Microbiology device
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Jan 1989
Decision
147d
Days
Class 2
Risk

K883544 is an FDA 510(k) clearance for the LYME FAST TEST. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by 3M Company (Santa Clara, US). The FDA issued a Cleared decision on January 13, 1989 after a review of 147 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K883544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1988
Decision Date January 13, 1989
Days to Decision 147 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 102d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 50
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K883544.
BORRELIA BURGDORFERI IGG ANTIBODY TEST SYSTEM
K885293 · Medical Diagnostic Technologies, Inc. · Apr 1989
BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM
K885294 · Medical Diagnostic Technologies, Inc. · Apr 1989
LYME ELISA TEST SYSTEM
K885317 · Zeus Scientific, Inc. · Mar 1989
IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERI
K871246 · Zeus Scientific, Inc. · Aug 1987