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SPIFE IFE Calibrator and Control Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K010617

by Helena Laboratories

Identifiers

510(k) Number
K010617 FDA 510(k)
FDA Product Code
DEW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5510 FDA 510(k)
Regulation Number
866.5510 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SPIFE IFE Calibrator and Control Kit is a set of controls and calibrators designed for use with immunofixation electrophoresis (IFE) systems. It provides reference standards for quantifying and validating immunoglobulin (IgG) and related protein assays, ensuring accurate and reproducible test results in immunology laboratories. The kit includes multiple antigen and antiserum controls to support the identification and characterization of monoclonal proteins and other serum components.

This kit is intended for in vitro diagnostic use in clinical laboratories and is supplied as a non-sterile, single-use product. It is classified under FDA regulation number 866.5510 and falls under device class II. The controls are pre-packaged and require no additional preparation beyond reconstitution or dilution as specified in the accompanying instructions. The kit is authorized under FDA 510(k) clearance (K010617) and is intended for use with immunofixation electrophoresis systems to maintain assay performance and precision.

Frequently asked questions

What is the SPIFE IFE Calibrator and Control Kit used for?

This kit is designed for use with immunofixation electrophoresis (IFE) systems in clinical laboratories. It provides reference standards—including antigen and antiserum controls—to quantify and validate immunoglobulin (IgG) and related protein assays. This ensures accurate identification and characterization of monoclonal proteins and other serum components, maintaining assay performance and reproducibility.

Is the SPIFE IFE Calibrator and Control Kit sterile?

No, the kit is supplied as a non-sterile product. It is intended for single-use only, and no additional preparation beyond reconstitution or dilution (as instructed) is required before use.

How is the SPIFE IFE Calibrator and Control Kit supplied?

The kit is pre-packaged and ready for immediate use. It contains multiple controls and calibrators that only require reconstitution or dilution according to the provided instructions. This eliminates the need for further preparation steps, streamlining workflow in immunology laboratories.

Can the SPIFE IFE Calibrator and Control Kit be reused?

No, the kit is explicitly designed for single-use only. Reusing it could compromise the accuracy and reliability of assay results, as the controls and calibrators are intended to be used once per test run.

What regulatory pathway does the SPIFE IFE Calibrator and Control Kit follow?

The kit is authorized under FDA 510(k) clearance (K010617) and is classified under FDA regulation number 866.5510 as a Class II device. It was determined to be substantially equivalent to a predicate device through the traditional 510(k) review process, with the Immunology (IM) Advisory Committee providing advisory input.

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: SPIFE IFE CALIBRATOR AND CONTROL KIT (K010617) - FDA 510 (k), SPIFE IFE CALIBRATOR AND CONTROL KIT - Innolitics, SPIFE Nexus | Helena Laboratories - Innovations for Science & Clinical ..., SPIFE Touch Immunofixation | Helena Laboratories - Innovations for ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Helena Laboratories

Sources (1)

  • FDA 510(k) K010617 24 fields · synced Oct 1, 2026