AP 72OS Semi-Automated Instrument

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

510(k) Number

K112910 ↗

FDA Product Code

DHB

Device Class

Class II

Regulation

21 CFR Part 866.5750

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• What is the AP 72OS Semi-Automated RAST Immunology System used for?

  The AP 72OS is designed for in vitro diagnostic testing to quantify immunoglobulin E (IgE) antibodies in human serum. This helps identify IgE-mediated allergic disorders by processing allergen-specific IgE assays, aiding clinicians in diagnosing conditions like allergies or asthma. It improves efficiency in immunology laboratories by automating sample aspiration and assay processing.

• Is the AP 72OS Semi-Automated RAST Immunology System reusable or single-use?

  The AP 72OS is supplied as a reusable instrument, intended for repeated use in clinical settings such as immunology laboratories. Reusability is maintained through adherence to the manufacturer’s sterility and maintenance protocols, which are detailed in the accompanying instructions.

• What assay compatibility does the AP 72OS require?

  The AP 72OS is specifically designed for compatibility with the OPTIGEN Assay. This ensures accurate processing of allergen-specific IgE tests, allowing laboratories to perform reliable diagnostic evaluations for IgE-mediated allergic conditions.

• How is sterility maintained for the AP 72OS?

  Sterility for the AP 72OS is maintained according to the manufacturer’s specified protocols, which are outlined in the device’s instructions. These protocols likely include cleaning, disinfection, and other procedural steps to ensure safe reuse in clinical environments. For precise details, refer to the manufacturer’s guidelines.

• What regulatory approval does the AP 72OS hold?

  The AP 72OS Semi-Automated RAST Immunology System has received FDA 510(k) clearance under the designation K112910. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and is classified as a Class II medical device under FDA regulations.