Cleared Traditional

K892206 - MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM

K892206 is an FDA 510(k) clearance for MARDX LLYME DISEASE EIA (IGG & IGM) TES..., 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 134-day FDA review.

K892206 · Mardx Diagnostics, Inc. · Microbiology device
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Aug 1989
Decision
134d
Days
Class 2
Risk

K892206 is an FDA 510(k) clearance for the MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Mardx Diagnostics, Inc. (Scotch Plains, US). The FDA issued a Cleared decision on August 15, 1989 after a review of 134 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 Mardx Diagnostics, Inc. devices

FDA 510(k) Submission Details - K892206

510(k) Number K892206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1989
Decision Date August 15, 1989
Days to Decision 134 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 102d · This submission: 134d
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 91
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K892206.
LYME IGM MICROASSAY
K900572 · Diamedix Corp. · May 1990
LYME IGG ELISA TEST SYSTEM
K895292 · Zeus Scientific, Inc. · Dec 1989
IMMUNODOT LYME TEST
K894410 · General Biometrics, Inc. · Oct 1989
LYME DISEASE MICROASSAY
K890843 · Diamedix Corp. · Jul 1989
BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY
K885290 · Medical Diagnostic Technologies, Inc. · Apr 1989
BORRELIA BURGDORFERI IGG ANTIBODY TEST SYSTEM
K885293 · Medical Diagnostic Technologies, Inc. · Apr 1989