Modofication to Vitro Immunodiagnostic Products Psa Reagent Pack, Vitro Immunodiagnostic Products Psa Calibrators

No FDA recalls found in the data synced 23 Oct 2026.

510(k) Number

K000566 ↗

FDA Product Code

LTJ

Device Class

Class II

Regulation

21 CFR Part 866.6010

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Ortho-Clinical Diagnostics, Inc. →

• What is the Vitro Immunodiagnostic Products PSA Reagent Pack and Calibrators modification used for?

  This modification is designed for use with automated immunoassay systems to measure prostate-specific antigen (PSA) levels in blood samples. PSA testing is critical for screening, diagnosing, and monitoring prostate conditions, including prostate cancer. The modification ensures the reagent pack and calibrators remain compatible with existing Vitro systems, providing accurate quantitative results for clinical assessment.

• Are the PSA reagent pack and calibrators single-use or reusable?

  The Vitro Immunodiagnostic Products PSA Reagent Pack and PSA Calibrators are intended for single-use only in clinical laboratory settings. This design ensures sterility and reliability for each test, reducing the risk of cross-contamination and maintaining consistent performance.

• How should the PSA reagent pack and calibrators be stored?

  Storage and handling follow standard in vitro diagnostic protocols to preserve accuracy and reliability. While the exact storage conditions are not detailed in the provided data, typical guidelines for immunodiagnostic reagents include storing at 2–8°C (36–46°F) in a dry environment, protected from light and extreme temperatures. Always refer to the manufacturer’s instructions for precise storage requirements.

• What regulatory clearance does this modification have?

  This modification to the Vitro Immunodiagnostic Products PSA Reagent Pack and PSA Calibrators holds FDA 510(k) clearance (K000566) and is classified as a Class II device under regulation 866.6010. The clearance confirms that the modification is substantially equivalent to legally marketed devices, ensuring compliance with U.S. regulatory standards for in vitro diagnostics.

• Are the PSA reagent pack and calibrators compatible with all automated immunoassay systems?

  The modification is specifically designed to align with existing Vitro immunoassay systems for PSA measurement. While compatibility is ensured for these platforms, users should verify system-specific requirements before use. The manufacturer’s instructions should be consulted to confirm proper integration with the intended automated immunoassay system.