← Back to catalogue

Beta Thalquik Column #5341

FDA 510(k)

Class II (US FDA 510(k))

510(k) K823870

by Helena Laboratories

Identifiers

510(k) Number
K823870 FDA 510(k)
FDA Product Code
JPD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.7400 FDA 510(k)
Regulation Number
864.7400 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Beta-Thal HbA2 Quik Column #5341 is a diagnostic device classified as a Hemoglobin A2 Quantitation system. It is designed to measure and quantify Hemoglobin A2 levels in blood samples, aiding in the diagnosis and monitoring of beta-thalassemia and related hemoglobinopathies. This column-based assay provides a rapid and precise method for hematology laboratories to assess abnormal hemoglobin patterns.

This device is supplied as a single-use column kit and is intended for use in clinical laboratory settings. It requires no special storage conditions beyond standard laboratory practices and is regulated under FDA 510(k) clearance (K823870) as a Class II device under product code JPD. The device was authorized for commercial distribution in 1983 and remains compliant with FDA requirements for hemoglobin quantitation assays.

Frequently asked questions

What is the Beta-Thal HbA2 Quik Column #5341 used for?

The Beta-Thal HbA2 Quik Column #5341 is a diagnostic device designed specifically to measure and quantify Hemoglobin A2 levels in blood samples. Elevated or abnormal Hemoglobin A2 levels are key indicators for diagnosing and monitoring beta-thalassemia and other hemoglobinopathies. This column-based assay provides a rapid and precise method for hematology laboratories to assess abnormal hemoglobin patterns, aiding in accurate patient diagnosis and treatment planning.

How is the Beta-Thal HbA2 Quik Column #5341 supplied and intended for use?

The Beta-Thal HbA2 Quik Column #5341 is supplied as a single-use column kit, meaning each column is intended for one-time use only. It is exclusively designed for use in clinical laboratory settings, where trained professionals can perform the assay to quantify Hemoglobin A2 levels in patient blood samples. This ensures consistency, accuracy, and compliance with laboratory protocols.

Does the Beta-Thal HbA2 Quik Column #5341 require special storage conditions?

No special storage conditions are required beyond standard laboratory practices. The device should be stored in a clean, dry environment, protected from extreme temperatures and direct sunlight, following typical laboratory storage guidelines for diagnostic kits. This ensures the integrity and reliability of the assay when used.

Is the Beta-Thal HbA2 Quik Column #5341 reusable or single-use?

The Beta-Thal HbA2 Quik Column #5341 is explicitly designed as a single-use device. This design minimizes the risk of cross-contamination, ensures consistent performance, and maintains the accuracy of Hemoglobin A2 measurements. Single-use columns also align with best practices for laboratory safety and infection control.

What regulatory approval does the Beta-Thal HbA2 Quik Column #5341 hold?

The Beta-Thal HbA2 Quik Column #5341 holds FDA 510(k) clearance under the reference number K823870, classified as a Class II device under product code JPD. This clearance was granted in 1983 and confirms that the device meets FDA requirements for hemoglobin quantitation assays, ensuring its safety, effectiveness, and compliance with regulatory standards for diagnostic use in clinical settings.

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: BETA THALQUIK COLUMN #5341 (K823870) - FDA 510 (k), BETA THALQUIK COLUMN #5341 (K823870) — FDA 510(k) | Innolitics, HELENA LABORATORIES CORPORATION 5341 Beta-Thal HbA2 Quik Column Kit, Product List | Helena Laboratories - Innovations for Science & Clinical ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Helena Laboratories

Sources (1)

  • FDA 510(k) K823870 24 fields · synced Oct 1, 2026