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Titan Gel Alkaline Phosphatase (HR)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K921578

by Helena Laboratories

Identifiers

510(k) Number
K921578 FDA 510(k)
FDA Product Code
CIN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1050 FDA 510(k)
Regulation Number
862.1050 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Titan Gel Alkaline Phosphatase (HR) is an Electrophoretic Separation Device for identifying alkaline phosphatase isoenzymes in serum or plasma. It employs high-resolution agarose gel electrophoresis to distinguish between bone and liver fractions, enhancing diagnostic accuracy for conditions affecting the liver, bones, parathyroid, or intestines. The system leverages neuraminidase treatment to improve separation clarity, aiding in precise isoenzyme profiling.

This device is supplied as a kit for in-vitro diagnostic use, intended for laboratory settings. It is single-use and requires no sterilisation beyond manufacturer-provided packaging. The system operates under Class II (Risk Class B) regulatory classification (FDA 510(k) K921578) and is authorised for clinical chemistry applications. Storage conditions and shelf life are specified in accompanying documentation, with compliance ensured through FDA clearance for traditional 510(k) pathways.

Frequently asked questions

What is the Titan Gel Alkaline Phosphatase (HR) used for?

This device is designed for identifying alkaline phosphatase isoenzymes in serum or plasma using high-resolution agarose gel electrophoresis. It helps differentiate between bone and liver fractions, which is critical for diagnosing conditions affecting the liver, bones, parathyroid, or intestines. The neuraminidase treatment included in the kit enhances separation clarity, ensuring accurate isoenzyme profiling for clinical chemistry applications.

How is the Titan Gel Alkaline Phosphatase (HR) supplied, and is it single-use?

The kit is supplied as a complete in-vitro diagnostic system for laboratory use. It is intended for single-use only, meaning each kit is designed for one analysis. No additional sterilization beyond the manufacturer-provided packaging is required, as the device is pre-sterilized and sealed.

Does this device require special storage conditions, and what is its shelf life?

Storage conditions and shelf life details are provided in the accompanying documentation. The manufacturer ensures compliance with these requirements to maintain the device’s performance. Always refer to the included instructions for precise storage guidelines, as improper storage could affect accuracy.

Is the Titan Gel Alkaline Phosphatase (HR) reusable, or is it meant for one-time use?

This device is explicitly designed for single-use only. Each kit is intended for one electrophoretic analysis, ensuring consistency and reliability in diagnostic results. Reusing the kit could compromise sterility and accuracy, so adherence to single-use guidelines is essential.

What regulatory pathway does the Titan Gel Alkaline Phosphatase (HR) follow?

The device follows the traditional 510(k) regulatory pathway and is classified under Class II (Risk Class B) for clinical chemistry applications. It was cleared by the FDA through a 510(k) submission (K921578) and is authorized for use in laboratory settings for in-vitro diagnostic purposes.

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: TITAN Gel Proteins | Helena Laboratories - Innovations for Science ..., PDF 3058 - helena.com, TITAN GEL ALKALINE PHOSPHATASE (HR) - Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Helena Laboratories

Sources (1)

  • FDA 510(k) K921578 24 fields · synced Oct 1, 2026