ELECSYS PROBNP II CALCHECK

K080147 · Roche Diagnostics Corp. · JJX · Feb 27, 2008 · Clinical Chemistry

Device Facts

• Record ID: K080147
• Device Name: ELECSYS PROBNP II CALCHECK
• Applicant: Roche Diagnostics Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Feb 27, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

For use in the verification of the calibration established by the Elecsys proBNP II reagent on the Elecsys and cobas e immunoassay analyzers. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys proBNP II CalCheck is a lyophilized quality control material; consists of NT-proBNP (1-76) amide human serum and potassium phosphate buffered matrix. Used in clinical laboratory settings to verify calibration of Elecsys proBNP II reagent on Elecsys and cobas e immunoassay analyzers. Product requires reconstitution with distilled or deionized water before use. Healthcare professionals use the output to confirm the accuracy of the immunoassay analyzer's calibration, ensuring reliable patient test results for proBNP levels.

Clinical Evidence

No clinical data. Bench testing only. Stability testing protocols and acceptance criteria were reviewed and found acceptable. Values are assigned via multiple analyses on multiple analyzers calibrated against reference standards.

Technological Characteristics

Lyophilized product; NT-proBNP (1-76) amide in human serum and potassium phosphate buffered matrix. Three concentration levels. Storage 2-8°C. Reconstituted stability: 4 hours at 25°C. Analyte concentration levels achieved via spiking during manufacture.

Indications for Use

Indicated for use as a quality control material to verify calibration of the Elecsys proBNP II reagent on Elecsys and cobas e immunoassay analyzers. Prescription use only.

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.

Predicate Devices

• Elecsys proBNP CalCheck (k020883)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
k080147

B. Purpose for Submission:
Modification to QC/control material

C. Measurand:
proBNP control

D. Type of Test:
Quality control material for proBNP

E. Applicant:
Roche Diagnostics

F. Proprietary and Established Names:
Elecsys proBNP II CalCheck

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1660 Quality control material (assayed and unassayed)
2. Classification:
Class I, reserved
3. Product code:
JJX - single (specified) analyte controls (assayed and unassayed)
4. Panel:
Clinical Chemistry (75)

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H. Intended Use:

1. Intended use(s):
See indications for use below

2. Indication(s) for use:
For use in the verification of the calibration established by the Elecsys proBNP II reagent on the Elecsys and cobas e immunoassay analyzers.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Elecsys and cobas e immunoassay analyzers.

3. Special conditions for use statement(s):
For prescription use only

4. Special instrument requirements:
Elecsys or Cobas e immunoassay analyzer

I. Device Description:

The Elecsys proBNP II CalCheck is a lyophilized product consisting of NT-proBNP (1-76) amide human serum and potassium phosphate buffered matrix. During manufacture the analytes are spiked into the matrix at the desired concentration levels. In the labeling the sponsor states that each donor unit was tested for hepatitis B surface antigen, antibodies to hepatitis C and antibodies to HIV and found to be negative.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Elecsys proBNP CalCheck

2. Predicate K number(s):
k020883

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Elecsys proBNP II CalCheck (Device) | Elecsys proBNP CalCheck (Predicate) |
| Levels | Three | Three |
| Format | Lyophilized | Lyophilized |
| Handling | Reconstitute with exactly 1.0 mL distilled or deionized water and allow to stand closed for 15 minutes, then mix gently. | Reconstitute with exactly 1.0 mL distilled or deionized water and allow to stand closed for 15 minutes, then mix gently. |
| Storage | 2 - 8°C | 2 - 8°C |
| Matrix | Level 1: NT-proBNP free human serum Levels 2/3: synthetic NT-proBNP in human serum/buffer matrix | Level 1: NT-proBNP free human serum Levels 2/3: synthetic NT-proBNP in human serum/buffer matrix |
| Differences | | |
| --- | --- | --- |
| Item | Elecsys proBNP II CalCheck (Device) | Elecsys proBNP CalCheck (Predicate) |
| Intended use | Intended for use in the verification of the calibration established by the Elecsys proBNP II reagent on the Elecsys and cobas e analyzers | Intended for use in the verification of the calibration established by the Elecsys proBNP reagent on the Elecsys and cobas e analyzers |

K. Standard/Guidance Document Referenced (if applicable):

Not applicable

L. Test Principle:

Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

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a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Values are assigned by multiple analyses on multiple analyzers. Runs are calibrated against reference standards produced by weighing in pure synthetic NT-proBNP (1-76) amide in a human serum matrix. The target value is calculated as the median of the determined values.

Stability testing protocols and acceptance criteria were described and found to be acceptable. The CalCheck is stable until the expiration date printed on the vial when stored unopened at 2 – 8° C. Reconstituted vials are stable for four hours at 25°C.

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

f. Assay cut-off:

Not applicable

2. Comparison studies:

a. Method comparison with predicate device:

Not applicable

b. Matrix comparison:

Not applicable

3. Clinical studies:

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a. Clinical Sensitivity:
Not applicable

b. Clinical specificity:
Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Not applicable

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.