LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS

K031577 · Cliniqa Corporation · JJY · Aug 6, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031577
• Device Name: LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS
• Applicant: Cliniqa Corporation
• Product Code: JJY · Clinical Chemistry
• Decision Date: Aug 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The LiniCAL Protein 2 Calibration Verifiers Levels A – E for Beckman Coulter Array Protein Systems is intended for use as an assayed quality control material for analysis.

Device Story

LiniCAL™ Protein 2 Calibration Verifiers are assayed quality control materials used in clinical laboratory settings. The device serves as a reference to verify the calibration and performance of Beckman Coulter Array® Protein Systems. Laboratory technicians use the product to monitor the accuracy and precision of protein analysis assays. By comparing system results against the provided assayed values, the device helps ensure the reliability of patient sample testing, thereby supporting accurate clinical decision-making by healthcare providers.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Serum-based quality control material; five assayed levels; contains Alpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, Alpha-2-Macroglobulin, Antithrombin III, Beta-2-Macroglobulin, and Ceruloplasmin. Designed for use with Beckman Coulter Array Protein Systems.

Indications for Use

Indicated for use as an assayed quality control material for monitoring the reportable range of Alpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, Alpha-2-Macroglobulin, Antithrombin III, Beta-2-Macroglobulin, and Ceruloplasmin on Beckman Coulter Array Protein Systems.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE TEMPLATE

A. 510(k) Number: K031577

B. Analyte: Protein 2 Calibration verifiers A – E for Beckman Coulter Array Protein Systems containing the following analytes; Alpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, Alpha-2-Macroglobulin, Antithrombin III, Beta-2-Macroglobulin and Ceruloplasmin.

C. Type of Test: n/a

D. Applicant: CLINIQA

E. Proprietary and Established Names: Quality Control Material

F. Regulatory Information:
1. Regulation section: 21 CFR 862.1660
2. Classification: Class 1
3. Product Code: JJY
4. Panel: 75

G. Intended Use:
1. Indication(s) for use: The LiniCAL Protein 2 Calibration Verifiers Levels A – E for Beckman Coulter Array Protein Systems is intended for use as an assayed quality control material for analysis.
2. Special condition for use statement(s): none
3. Special instrument Requirements: none

H. Device Description: The Protein 2 Calibration Verifiers are used in the clinical laboratory to verify calibration and/or assess linearity of the Beckman Coulter Array Protein Systems. Five assayed levels of Alpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, Alpha-2-Macroglobulin, Antithrombin III, Beta-2-Macroglobulin and Ceruloplasmin are provided to allow monitoring of the reportable range.

I. Substantial Equivalence Information:
1. Predicate device name(s): LiniCAL Protein 2 Calibration Verifiers Levels A-E for Beckman Immage

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2. Predicate K number(s): K023250

3. Comparison with predicate: Both devices are serum based products containing Alpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, Alpha-2-Macroglobulin, Antithrombin III, Beta-2-Macroglobulin and Ceruloplasmin and are manufactured using the same processes. The difference between the two products is the constituent concentration has been optimized for this test system.

J. Standard/Guidance Document Referenced (if applicable): N/A

K. Test Principle: N/A

L. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility: N/A
b. Linearity/assay reportable range: N/a
c. Traceability (controls, calibrators, or method): None provided
d. Detection limit (functional sensitivity): N/A
e. Analytical specificity: N/A
f. Assay cut-off: N/A

2. Comparison studies:
a. Method comparison with predicate device: N/A
b. Matrix comparison: N/A

3. Clinical studies:
a. Clinical sensitivity: N/A
b. Clinical specificity: N/A

4. Clinical cut-off: N/A

5. Expected values/Reference range: N/A

M. Conclusion: Based upon the information provided, I recommend that the CliniqaLiniCAL Protein 2 Calibration verifiers Levels A-E for Beckman Coulter Array Protein Systems be found substantially equivalent with predicate devices according to 21 CFR 862.1660.