Cleared Traditional

K950829 - MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM

K950829 is an FDA 510(k) clearance for MARDX LYME DISEASE (IGG) MARBLOT STRIP ..., manufactured by Mardx Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 468-day FDA review.

K950829 · Mardx Diagnostics, Inc. · Microbiology device
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Jun 1996
Decision
468d
Days
Class 2
Risk

K950829 is an FDA 510(k) clearance for the MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Mardx Diagnostics, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 5, 1996 after a review of 468 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 Mardx Diagnostics, Inc. devices

FDA 510(k) Submission Details - K950829

510(k) Number K950829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1995
Decision Date June 05, 1996
Days to Decision 468 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
366d slower than avg
Panel avg: 102d · This submission: 468d
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 90
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K950829.
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
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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
IMMUNO DOT BORRELIA DOT BLOT G TEST
K953682 · Genbio · May 1996
MMUNO DOT BORRELIA DOT BLOT M TEST
K953683 · Genbio · May 1996
VIDAS LYME SCREEN II
K943812 · Biomerieux Vitek, Inc. · Jun 1995