Cleared Traditional

K965129 - BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM

K965129 is an FDA 510(k) clearance for BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM, manufactured by Wampole Laboratories. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K965129 · Wampole Laboratories · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
93d
Days
Class 2
Risk

K965129 is an FDA 510(k) clearance for the BORRELIA BURGDORFERI 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

FDA 510(k) Submission Details - K965129

510(k) Number K965129 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
Combination Product No
PCCP Authorized No
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.

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 97
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K965129.
CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)
K971170 · Cambridge Biotech Corp. · Feb 1998
ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL
K974809 · Boston Biomedica, Inc. · Feb 1998
ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
K974810 · Boston Biomedica, Inc. · Feb 1998
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
K965131 · Wampole Laboratories · Mar 1997
MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM
K951709 · Mardx Diagnostics, Inc. · Jun 1996
MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
K950829 · Mardx Diagnostics, Inc. · Jun 1996