Linical Protein III Calibration Verifiers Levels A-E for Beckman Array Protein System

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

510(k) Number

K953926 ↗

FDA Product Code

DCK

Device Class

Class II

Regulation

21 CFR Part 866.5270

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Hscrp Control Level 1, Hscrp Control Level 2, and Hscrp Control Level 3

  Class I

  FDA 510(k) K011169 Active Cleared 18 May 2001

• Linical Protein I Calibration Verifiers Levels a - for Beckman Array 360 System

  Class I

  FDA 510(k) K950802 Active Cleared 1 Jun 1995

• Liquid Immunology Control Level I, II, III

  Class I

  FDA 510(k) K963085 Active Cleared 20 Aug 1996

• Linical Protein VI Calibration Verifiers Levels a-E

  Class I

  FDA 510(k) K944513 Active Cleared 2 Dec 1994

• Linical Protein I Calibration Verifiers Levels a - E

  Class I

  FDA 510(k) K944486 Active Cleared 2 Dec 1994

• Linical Protein VI Calibration Verifiers Levels a-E for Beckman Array Protein System

  Class II

  FDA 510(k) K953927 Active Cleared 15 Sep 1995

• What is the primary purpose of the LINICAL Protein III Calibration Verifiers Levels A-E for the Beckman Array Protein System?

  The LINICAL Protein III Calibration Verifiers are used to verify the calibration and linearity of Beckman-Coulter Immage™ analytical systems. They provide known protein concentrations in a human-serum protein matrix to ensure the accuracy and reliability of clinical laboratory testing for protein assays.

• How are these calibration verifiers supplied and stored?

  They are supplied as ready-to-use liquid materials in a stable human-serum protein matrix. Storage requires refrigeration between 2-8 °C, making them suitable for use in clinical laboratory settings where temperature control is standard.

• Are these calibration verifiers intended for single-use or repeated use?

  The device is designed for use in the clinical laboratory to validate instrument performance, but the specific reuse instructions are not detailed in the data. Typically, calibration verifiers like these are used once per calibration cycle or as needed for quality control checks, though proper documentation of usage would be required to ensure compliance with laboratory protocols.

• What regulatory pathway was followed for FDA clearance of this device?

  The LINICAL Protein III Calibration Verifiers received FDA clearance through a 510(k) submission, classified as Substantially Equivalent (SE) under the Traditional clearance type. The device falls under product code DCK and is regulated under 21 CFR 866.5270, with an advisory committee designation in Immunology. The clearance number is K953926.

• What types of protein measurements does this calibration verifier support?

  While the device itself is not a measurement tool, it is specifically designed to validate the performance of Beckman-Coulter Immage™ systems for C-Reactive Protein (CRP) and related protein assays. The verifiers ensure the accuracy of quantitative protein measurements in clinical laboratories, particularly those using the Beckman Array Protein System.