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PolyTiter System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K012163

by Polymedco, Inc.

Identifiers

510(k) Number
K012163 FDA 510(k)
FDA Product Code
DHN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5100 FDA 510(k)
Regulation Number
866.5100 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The PolyTiter System is an Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control device, classified under the Immunology category. It is designed for use in immunofluorescence assays to detect and quantify antinuclear antibodies (ANA) in serum or plasma samples, aiding in the diagnosis of autoimmune diseases such as systemic lupus erythematosus (SLE) and other connective tissue disorders.

This system is intended for laboratory use and is supplied as a single-use or reusable component set, depending on the specific antigen controls included. It operates under Class 2 regulatory classification (product code DHN) and has received FDA 510(k) clearance through the Traditional pathway. Sterility and handling instructions are detailed in the accompanying documentation, and proper storage conditions must be maintained to preserve functionality. The device is authorized under regulation number 866.5100 and is intended for use in accredited clinical laboratories.

Frequently asked questions

What is the PolyTiter System used for in a clinical laboratory setting?

The PolyTiter System is designed specifically for immunofluorescence assays to detect and quantify antinuclear antibodies (ANA) in serum or plasma samples. It aids in diagnosing autoimmune diseases like systemic lupus erythematosus (SLE) and other connective tissue disorders by providing antigen controls for reliable assay performance.

Is the PolyTiter System intended for single-use or reusable applications, and how should it be handled?

The PolyTiter System can be supplied as either single-use or reusable, depending on the specific antigen controls included in the kit. Handling instructions, including sterility considerations, are detailed in the accompanying documentation, so proper protocols must be followed to maintain functionality and prevent contamination.

What regulatory pathway was followed for FDA clearance of the PolyTiter System, and what classification does it fall under?

The PolyTiter System received FDA 510(k) clearance through the Traditional pathway and is classified under Class 2 (product code DHN). It is authorized under regulation number 866.5100 and is intended exclusively for use in accredited clinical laboratories.

Are there different sizes or models available for the PolyTiter System, and how should it be stored?

While the provided data does not specify distinct sizes or models beyond the reusable/single-use distinction, the PolyTiter System requires adherence to storage conditions outlined in its documentation to preserve functionality. Proper storage is critical to maintaining the integrity of the antigen controls for accurate assay performance.

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: Polymedco | Colorectal Cancer & Cardiac Diagnostics Solutions, Polymedco Colorectal Cancer (CRC) Screening FIT Solutions - Polymedco, Class 3 Device Recall Programming software for Polymedco PolyTiter ..., K012163 FDA 510 (k) - POLYTITER SYSTEM | Polymedco, Inc., Polytiter Immunofluorescence System | Polymedco inc | Bioz

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Polymedco, Inc.

Sources (1)

  • FDA 510(k) K012163 24 fields · synced Sep 19, 2026