Immage Immunochemistry System Immunoglobulin G (IgG), A (IgA) and M (IgM)

• • Ongoing Z-0118-2025 FDA Class II ·initiated 31 Jul 2024

  Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU

• • Terminated Z-1150-04 FDA Unclassified (pre-2012) ·initiated 6 Jun 2003

  low level IgM serum sample results may be suppressed and an error code generated when using affected lots. Error codes are seen as E60 or E66.

510(k) Number

K963868 ↗

FDA Product Code

DEW

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Beckman Hdl Cholesterol Reagent

  Class I

  FDA 510(k) K934045 Active Cleared 14 Oct 1993

• Beckman Urine Protein Calibrator (Ucal)

  Class II

  FDA 510(k) K973928 Active Cleared 1 Dec 1997

• Beckman Uric Acid Reagent

  Class I

  FDA 510(k) K821812 Active Cleared 2 Jul 1982

• Immage Immunochemistry System Alpha-2-Macroglobulin Reagent

  Class II

  FDA 510(k) K974564 Active Cleared 17 Feb 1998

• Immage Immunochemistry System Ceruloplasmin (Cer) Reagent

  Class II

  FDA 510(k) K964762 Active Cleared 25 Apr 1997

• Immage Immunochemistry System Haptoglobin (Hpt) Reagent

  Class II

  FDA 510(k) K963286 Active Cleared 7 Oct 1996

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• What types of immunoglobulins can the Immage Immunochemistry System measure, and how does it perform these measurements?

  The Immage Immunochemistry System is designed to quantitatively measure human immunoglobulins IgG, IgA, and IgM. It uses rate nephelometry, a turbidimetric immunoassay technique, to detect antigen-antibody reactions by measuring light scattering in a sample. This method provides precise and reliable quantification of these immunoglobulins in clinical settings.

• Is the Immage Immunochemistry System intended for single-use, or can it be reused in a clinical laboratory?

  The Immage Immunochemistry System is not single-use. It is part of the Beckman IMMAGE Immunochemistry platform and is intended for repeated use in clinical immunology laboratories. However, proper maintenance and validation procedures must be followed as outlined by the manufacturer to ensure accurate and reliable results over time.

• What calibration requirements does the Immage Immunochemistry System have, and what supplies are needed for its operation?

  The system requires calibration using Beckman Calibrator 1 to ensure accurate measurements. It is supplied as part of the Beckman IMMAGE Immunochemistry platform, which includes necessary reagents and components for operation. Additional consumables, such as controls and antisera, are referenced by their registration numbers in the provided data.

• How is the regulatory status of the Immage Immunochemistry System defined, and what does this mean for its use in clinical settings?

  The Immage Immunochemistry System holds FDA 510(k) clearance and IVDD authorization, classifying it as a Class II device under FDA regulations (866.5510). This means it has been deemed substantially equivalent to a predicate device and meets the necessary safety and performance standards for use in clinical immunology laboratories. The system is intended for in vitro diagnostic purposes only.

• What kind of maintenance or validation procedures should be followed when using the Immage Immunochemistry System?

  Since the Immage Immunochemistry System is not single-use, it requires adherence to manufacturer guidelines for maintenance and validation procedures. These procedures ensure the system’s accuracy, reliability, and proper functioning over time, which is critical for consistent measurement of IgG, IgA, and IgM in clinical settings. Regular maintenance helps prevent drift in results and ensures compliance with laboratory standards.