Cleared Traditional

K965131 - BORRELIA BURGDORFERI IGG/IGM ELISA TEST...

K965131 is the FDA 510(k) clearance for BORRELIA BURGDORFERI IGG/IGM ELISA TEST... by Wampole Laboratories. It is a Class 2 Microbiology device (product code LSR) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K965131 · Wampole Laboratories · Microbiology device
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Mar 1997
Decision
93d
Days
Class 2
Risk

K965131 is an FDA 510(k) clearance for the BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Wampole Laboratories (Cranbury, US). The FDA issued a Cleared decision on March 26, 1997 after a review of 93 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.

View all Wampole Laboratories devices

Submission Details

510(k) Number K965131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1996
Decision Date March 26, 1997
Days to Decision 93 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
9d faster than avg
Panel avg: 102d · This submission: 93d
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 55
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K965131.
QUANTA LITE LYME IGG ELISA
K984222 · Inova Diagnostics, Inc. · Apr 1999
QUANTA LITE LYME IGM ELISA
K984234 · Inova Diagnostics, Inc. · Apr 1999
APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM
K984138 · Zeus Scientific, Inc. · Mar 1999
VIDAS LYME SCREEN II
K943812 · Biomerieux Vitek, Inc. · Jun 1995
BARTELS LYME DISEASE IGM EIA
K922578 · Baxter Diagnostics, Inc. · Sep 1992
LYME-SPOT IF KIT
K910230 · Vitek Systems, Inc. · Aug 1991