Ciba Corning ACS Vancomycin Immunoassay

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K951059 ↗

FDA Product Code

LEH

Device Class

Class II

Regulation

21 CFR Part 862.3950

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Ciba Corning Diagnostics Corp. →

• What is the Ciba Corning ACS Vancomycin Immunoassay used for?

  This device is designed as an in vitro diagnostic radioimmunoassay to measure and quantify vancomycin concentrations in serum. It helps clinicians monitor antibiotic levels in patients receiving vancomycin, particularly in toxicology applications where precise dosing is critical to avoid toxicity or underdosing.

• How is the Ciba Corning ACS Vancomycin Immunoassay supplied, and who can use it?

  The assay is supplied as a kit intended exclusively for laboratory use. It must be performed by trained personnel in a clinical toxicology setting, as it requires specialized handling and interpretation of results. The kit is not intended for point-of-care or non-laboratory environments.

• Is the Ciba Corning ACS Vancomycin Immunoassay single-use or reusable?

  The device is explicitly designed for single-use only. Each kit is intended for one assay procedure, and reuse is not permitted to maintain accuracy, sterility, and regulatory compliance. Discard any unused components after use.

• What storage conditions are required for the Ciba Corning ACS Vancomycin Immunoassay?

  Like most immunoassay kits, this device requires proper storage to preserve its integrity. While exact conditions are not detailed in the provided data, standard practices for radioimmunoassay kits typically involve refrigeration (2–8°C) and protection from light and moisture. Always follow the manufacturer’s instructions included in the kit for optimal storage.

• Does the Ciba Corning ACS Vancomycin Immunoassay have any reusable components?

  No reusable components are specified for this device. The entire kit, including reagents and disposables, is intended for single-use only. This design ensures consistency in results and compliance with regulatory standards for in vitro diagnostics.