Cleared Traditional

K003754 - IMMUNETICS C6 LYME ELISA KIT

K003754 is an FDA 510(k) clearance for IMMUNETICS C6 LYME ELISA KIT, manufactured by Immunetics, Inc.. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K003754 · Immunetics, Inc. · Microbiology device
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May 2001
Decision
156d
Days
Class 2
Risk

K003754 is an FDA 510(k) clearance for the IMMUNETICS C6 LYME ELISA KIT. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Immunetics, Inc. (Cambridge,, US). The FDA issued a Cleared decision on May 10, 2001 after a review of 156 days - an extended review 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: 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.

View all Immunetics, Inc. devices

FDA 510(k) Submission Details - K003754

510(k) Number K003754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2000
Decision Date May 10, 2001
Days to Decision 156 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 102d · This submission: 156d
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 84
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K003754.
PLATELIA LYME IGM
K081362 · Bio-Rad · Jun 2008
PLATELIA LYME IGG ASSAY
K080012 · Bio-Rad · May 2008
LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870
K062473 · DiaSorin, Inc. · Apr 2007
QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT
K994004 · Inova Diagnostics, Inc. · Jan 2000
QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024
K991062 · Immunetics, Inc. · Sep 1999
QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024
K991063 · Immunetics, Inc. · Sep 1999