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Qualicode B. Burgdorferi IgM Western Blot Kit, Model DK-C062-024

FDA 510(k)

Class II (US FDA 510(k))

510(k) K991062

by Immunetics, Inc.

Identifiers

510(k) Number
K991062 FDA 510(k)
FDA Product Code
LSR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3830 FDA 510(k)
Regulation Number
866.3830 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Qualicode B. Burgdorferi IgM Western Blot Kit, Model DK-C062-024, is a Reagent, Borrelia Serological Reagent designed for the qualitative detection of IgM antibodies to Borrelia burgdorferi in human serum. This in vitro diagnostic device employs Western blot technology to confirm or support suspected Lyme disease infections when initial screening tests (such as EIA or IFA) yield positive or equivocal results. The kit identifies specific antibody responses to B. burgdorferi antigens, aiding in the differential diagnosis of Lyme borreliosis.

This single-use, non-sterile reagent kit is intended for use in microbiology laboratories and requires no special storage conditions beyond those specified in the accompanying instructions. It is classified as a Class II medical device under FDA regulations (21 CFR 866.3830) and holds a FDA 510(k) clearance (K991062) as substantially equivalent to a predicate device. The kit is supplied with all necessary components for performing Western blot assays, including controls and reagents, and must be handled in accordance with standard laboratory practices for infectious disease testing.

Frequently asked questions

What is the Qualicode B. Burgdorferi IgM Western Blot Kit DK-C062-024 used for?

This kit is designed for the qualitative detection of IgM antibodies to *Borrelia burgdorferi* in human serum. It employs Western blot technology to confirm or support suspected Lyme disease infections when initial screening tests (such as EIA or IFA) yield positive or equivocal results. It aids in differentiating Lyme borreliosis from other conditions by identifying specific antibody responses to *B. burgdorferi* antigens.

How is the Qualicode B. Burgdorferi IgM Western Blot Kit DK-C062-024 supplied, and is it sterile?

The kit is supplied as a single-use, non-sterile reagent kit containing all necessary components for performing Western blot assays, including controls and reagents. It is intended for use in microbiology laboratories and does not require special storage conditions beyond those outlined in the accompanying instructions.

Is this kit reusable, and what regulatory clearance does it hold?

The Qualicode B. Burgdorferi IgM Western Blot Kit DK-C062-024 is intended for single-use only. It holds FDA 510(k) clearance (K991062) and is classified as a Class II medical device under FDA regulations (21 CFR 866.3830), with a decision of substantial equivalence to a predicate device.

What storage requirements does the kit have?

The kit does not require special storage conditions beyond those specified in the accompanying instructions. Standard laboratory practices for infectious disease testing should be followed to ensure proper handling and storage.

Where can this kit be used, and what laboratory setting is appropriate?

This kit is intended exclusively for use in microbiology laboratories. It is designed for in vitro diagnostic testing and requires adherence to standard laboratory practices for infectious disease testing, including biosafety protocols to handle potentially infectious materials.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Qualicode B. Burgdorferi Igm Western Blot Kit, Model Dk-c062-024, QualiCodeTM B. burgdorferi IgG/IgM Western Blot Kits, QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024 510 (k ..., PDF K991062 - Qualicode B. Burgdorferi Igm Western Blot Kit, Model Dk-c062-024, Immunetics receives FDA approval for Lyme IgG and IgM Western Blot Kits

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Immunetics, Inc.

Sources (1)

  • FDA 510(k) K991062 24 fields · synced Oct 6, 2026