BCS Glucose Colorimetric Test

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

510(k) Number

K850257 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Bioclinical Systems, Inc. →

• What clinical purpose does the BCS Glucose Colorimetric Test serve?

  It provides a quantitative determination of glucose concentration in patient specimens using a glucose oxidase reaction, allowing laboratories to monitor blood glucose levels for diagnosis and management of metabolic disorders.

• Is the test supplied as a single‑use kit or can it be reused?

  The device is intended for single‑use in a clinical laboratory setting; each test unit is used once to ensure accurate results and to prevent cross‑contamination between samples.

• How is the BCS Glucose Colorimetric Test classified and regulated?

  It is classified as a Class II medical device under the Clinical Chemistry specialty. The product received traditional 510(k) clearance (K850257) from the FDA on March 5 1985, indicating it is substantially equivalent to a legally marketed predicate.

• What are the storage requirements for the test kits?

  The kits should be stored at the temperature recommended by the manufacturer, typically a controlled room temperature environment, and kept in their original packaging until use to maintain reagent stability.

• Can the BCS Glucose Colorimetric Test be used outside of a laboratory?

  The device is intended for use in clinical laboratory settings only; it is not designed for point‑of‑care or home use because it requires specific instrumentation and controlled conditions to produce reliable quantitative results.