Quick Start Glucose Item #5A15

No FDA recalls on record, checked 22 Oct 2026.

Full name

Abbott Quick Start Glucose (Glue) Item# 5A15

510(k) Number

K912808 ↗

FDA Product Code

CFR

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the Abbott Quick Start Glucose (GLUE) Item #5A15, and where would it typically be used?

  The Abbott Quick Start Glucose (GLUE) Item #5A15 is a hexokinase-based glucose test system designed for measuring glucose levels in blood samples. It is specifically intended for in vitro diagnostic use in clinical chemistry settings, enabling quantitative measurement of blood glucose concentrations. This makes it suitable for laboratories where precise glucose monitoring is required for clinical assessments.

• Is this device single-use or reusable, and does it require additional sterilization?

  The Abbott Quick Start Glucose (GLUE) Item #5A15 is supplied as a single-use reagent kit for laboratory use. Since it is designed for one-time use, no additional sterilization is required before use. This ensures consistency and safety in clinical chemistry applications.

• How should this device be stored to maintain its stability and accuracy?

  The device must be stored according to the manufacturer’s instructions to preserve stability and accuracy. While the exact storage conditions (e.g., temperature, humidity) are not detailed in the provided data, adhering to the manufacturer’s guidelines—likely outlined in the accompanying documentation—will ensure optimal performance for glucose measurement.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it fall under?

  The Abbott Quick Start Glucose (GLUE) Item #5A15 was cleared by the FDA under a 510(k) submission (K912808) using the Traditional 510(k) review pathway. It is classified under CFR 862.1345 and is determined to be substantially equivalent to a predicate device. The device falls under the Clinical Chemistry advisory committee (CH) and is categorized as a Class II medical device (as indicated by the OpenFDA data).