Cleared Traditional

K895713 - 3M IGG FASTLYME(TM) TEST

K895713 is the FDA 510(k) clearance for 3M IGG FASTLYME(TM) TEST by 3M Company. It is a Class 2 Microbiology device (product code LSR) cleared through the Traditional 510(k) pathway after a 445-day FDA review.

K895713 · 3M Company · Microbiology device
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Dec 1990
Decision
445d
Days
Class 2
Risk

K895713 is an FDA 510(k) clearance for the 3M IGG FASTLYME(TM) 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 December 14, 1990 after a review of 445 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all 3M Company devices

Submission Details

510(k) Number K895713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1989
Decision Date December 14, 1990
Days to Decision 445 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
343d slower than avg
Panel avg: 102d · This submission: 445d
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 K895713.
LYME DISEASE MICROASSAY
K910899 · Diamedix Corp. · Jun 1991
LYME IGM MICROASSAY
K911330 · Diamedix Corp. · Jun 1991
BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST
K911145 · Medical Diagnostic Technologies, Inc. · May 1991
LYME IGM ELISA TEST SYSTEM
K900196 · Zeus Scientific, Inc. · May 1990
LYME IGM MICROASSAY
K900572 · Diamedix Corp. · May 1990
LYME IGG ELISA TEST SYSTEM
K895292 · Zeus Scientific, Inc. · Dec 1989