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Lyphochek Hemoglobin A2 Control

FDA 510(k)

Class II (US FDA 510(k))

510(k) K911347

by Bio-Rad

Identifiers

510(k) Number
K911347 FDA 510(k)
FDA Product Code
JCM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.7415 FDA 510(k)
Regulation Number
864.7415 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Lyphochek Hemoglobin A2 Control is a lyophilized human whole blood-based control designed for monitoring automated and manual procedures that measure hemoglobin variants, including Hemoglobin A2, F, and S. Classified as a control for abnormal hemoglobin, it is intended for precision assessment in hematology applications.

Supplied as a bilevel lyophilized product in 0.5 mL aliquots, the control is intended for single-use and must be stored at 2–8°C. It is authorized under FDA 510(k) clearance (K911347) and falls under device class II (JCM product code) for hematology use. Open-vial stability is maintained for 21 days under refrigeration.

Frequently asked questions

What types of hemoglobin variants can this control help monitor in automated or manual hematology procedures?

The Lyphochek Hemoglobin A2 Control is specifically designed to monitor hemoglobin variants such as Hemoglobin A2, F, and S. Since it is a lyophilized human whole blood-based control, it provides a standardized reference for precision assessment in automated or manual testing systems used in hematology.

How should I store the Lyphochek Hemoglobin A2 Control before and after opening the vial?

Before opening, the control must be stored refrigerated between 2–8°C. Once opened, it remains stable for up to 21 days if kept refrigerated, ensuring reliable performance during that period.

Is this control intended for single-use only, and if so, why?

Yes, the Lyphochek Hemoglobin A2 Control is intended for single-use. This is because it is supplied in 0.5 mL aliquots of lyophilized human whole blood, which is designed to maintain consistency and accuracy for one testing session per vial.

What regulatory pathway was followed for FDA clearance of this control?

The Lyphochek Hemoglobin A2 Control received FDA clearance through a traditional 510(k) review process, classified as substantially equivalent (SESE) under the Hematology advisory committee (HE). The clearance number is K911347, and it falls under device class II with the product code JCM.

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: Lyphochek Hemoglobin A2 Control - Bio-Rad, Lyphochek Hemoglobin A₂ Control, Bilevel #553 | Bio-Rad, Lyphochek Hemoglobin A2 Control - Medline, Bio-Rad Hemoglobin A2 Control Overview | PDF - Scribd

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio-Rad

Sources (1)

  • FDA 510(k) K911347 24 fields · synced Sep 19, 2026