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Lyphochek Diabetes Control

FDA 510(k)

Class II (US FDA 510(k))

510(k) K070546

by Bio-Rad Laboratories

Identifiers

510(k) Number
K070546 FDA 510(k)
FDA Product Code
GGM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.8625 FDA 510(k)
Regulation Number
864.8625 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Lyphochek Diabetes Control is a lyophilized, human whole blood-based control used to monitor the clinical assay precision of hemoglobin fractions associated with diabetes, including Hemoglobins A1, A1C, F, Total Glycated Hemoglobin and Total Hemoglobin. It is provided in lyophilized form for ease of storage and increased stability.

The product is supplied as a bilevel control (e.g., Bilevel #740) with configurations such as 6 x 0.5 mL vials for Level 1 and 2 x 0.5 mL for Level 2. It is intended for in vitro diagnostic use and is authorized under FDA 510(k) clearance (K070546) as a Class II device with product code GGM, regulated under 21 CFR 864.8625 for hematology controls.

Frequently asked questions

What is the intended use of Lyphochek Diabetes Control?

Lyphochek Diabetes Control is used to monitor the clinical assay precision of hemoglobin fractions associated with diabetes, including Hemoglobins A1, A1C, F, Total Glycated Hemoglobin, and Total Hemoglobin. It is intended for in vitro diagnostic use only.

How is Lyphochek Diabetes Control supplied and stored?

The product is supplied in lyophilized (freeze-dried) form as a bilevel control, with configurations such as 6 x 0.5 mL vials for Level 1 and 2 x 0.5 mL vials for Level 2. The lyophilized format allows for ease of storage and increased stability.

Is Lyphochek Diabetes Control sterile and single-use?

The device data does not specify sterility or single-use status. As a lyophilized control material intended for in vitro diagnostic use, it is designed for laboratory use in assay monitoring, but users should consult the product labeling for specific handling, reconstitution, and use instructions.

What regulatory pathway was used for Lyphochek Diabetes Control?

Lyphochek Diabetes Control was authorized under FDA 510(k) clearance (K070546) as a Class II device. It is regulated under 21 CFR 864.8625 for hematology controls and has product code GGM.

What are the key specifications or identifiers for Lyphochek Diabetes Control?

The device is identified by the name LYPHOCHEK DIABETES CONTROL, manufacturer Bio-Rad Laboratories, FDA 510(k) number K070546, product code GGM, and is classified as a Class II device under regulation 21 CFR 864.8625. It was cleared via the Traditional 510(k) pathway on April 2, 2007.

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 Diabetes Control - Bio-Rad, Lyphochek Diabetes Control, Bilevel #740 | Bio-Rad, QCNet - My Inserts, Lyphochek Diabetes Control Overview | PDF | Glycated Hemoglobin | Assay

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio-Rad Laboratories

Sources (1)

  • FDA 510(k) K070546 24 fields · synced Sep 19, 2026