Lancer Glycosylated Hemoglobin Assay

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K810714 ↗

FDA Product Code

LCP

Device Class

Class II

Regulation

21 CFR Part 864.7470

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Sherwood Medical Co. →

• What is the Lancer Glycosylated Hemoglobin Assay used for?

  The Lancer Glycosylated Hemoglobin Assay is designed to quantitatively measure the percentage of hemoglobin A1c (HbA1c) in whole blood. HbA1c levels reflect average blood glucose concentrations over the preceding 2–3 months, making this assay a key tool for diagnosing and monitoring diabetes mellitus. It provides a non-invasive alternative to frequent blood glucose testing, helping clinicians assess long-term glycemic control.

• How is the Lancer Glycosylated Hemoglobin Assay supplied and intended for use?

  This device is supplied as a single-use laboratory test system, intended exclusively for use in hematology laboratories and clinical settings. It integrates seamlessly with standard hematology workflows and requires no additional sterility measures beyond routine laboratory practices. The assay is classified as a Class II medical device under FDA regulations, ensuring compliance with established diagnostic protocols.

• Is the Lancer Glycosylated Hemoglobin Assay sterile?

  The assay does not require special sterility measures beyond standard laboratory practices. Since it is a single-use system, it is designed to be handled in controlled laboratory environments where typical sterility protocols are already in place. No additional sterilization steps are specified for this device.

• What regulatory pathway was used for clearance of the Lancer Glycosylated Hemoglobin Assay?

  The Lancer Glycosylated Hemoglobin Assay was cleared via the Traditional 510(k) pathway by the FDA under the product code LCP (Laboratory Systems, Clinical Chemistry) and regulation number 864.7470. This pathway confirms that the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring its safety and effectiveness for measuring HbA1c levels.

• Are there specific storage requirements for the Lancer Glycosylated Hemoglobin Assay?

  Storage and handling of the Lancer Glycosylated Hemoglobin Assay follow standard in vitro diagnostic protocols. While specific storage conditions are not detailed in the provided data, it is generally recommended to adhere to manufacturer guidelines for maintaining assay integrity, such as protecting from extreme temperatures and moisture. No MRI safety considerations are noted for this device.