ELECSYS PROBNP II CALCHECK 5

K092169 · Roche Diagnostics · JJX · Dec 16, 2009 · Clinical Chemistry

Device Facts

• Record ID: K092169
• Device Name: ELECSYS PROBNP II CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Dec 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Elecsys proBNP II CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys proBNP II reagent on the indicated Elecsys and cobas e immunoassay analyzers. For prescription use only. The Elecsys proBNP II CalCheck is not intended to be used as a primary calibrator or routine control material.

Device Story

Elecsys proBNP II CalCheck 5 is a lyophilized, assayed quality control material; consists of NT-proBNP (1-76) amide spiked into human serum and potassium phosphate buffered matrix. Used in clinical laboratory settings by laboratory professionals to verify calibration and assay range of Elecsys proBNP II reagent on Elecsys and cobas e immunoassay analyzers. Product requires reconstitution with distilled or deionized water before use. Provides five concentration levels to support expanded range verification compared to the three-level predicate. Helps ensure accuracy and reliability of proBNP immunoassay results, supporting clinical decision-making for cardiac conditions.

Clinical Evidence

No clinical data. Bench testing only. Stability testing (real-time and accelerated) confirmed shelf-life and reconstituted stability. Value assignment performed using multiple Elecsys/cobas e analyzer systems to establish target values.

Technological Characteristics

Lyophilized synthetic NT-proBNP in human serum/buffer matrix. Five levels. Storage: 2-8°C unopened; 4 hours at 20-25°C reconstituted. Compatible with Elecsys 2010/cobas e411 and MODULAR ANALYTICS E 170/cobas e 601 systems.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys proBNP II reagent on Elecsys and cobas e immunoassay analyzers.

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 II CalCheck (k080147)

Submission Summary (Full Text)

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

A. 510(k) Number:
k092169

B. Purpose for Submission:
New device

C. Measurand:
Calibration verification and assay range verification material for Elecsys proBNP II Reagent

D. Type of Test:
Not applicable

E. Applicant:
Roche Diagnostics

F. Proprietary and Established Names:
Elecsys proBNP II CalCheck 5

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1660 Quality Control Material
2. Classification:
Class I, reserved
3. Product code:
JJX – single (specified) analyte controls
4. Panel:

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Clinical Chemistry (75)

## H. Intended Use:

1. Intended use(s):

See indications for use below.

2. Indication(s) for use:

The Elecsys proBNP II CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys proBNP II reagent on the indicated Elecsys and cobas e immunoassay analyzers.

3. Special conditions for use statement(s):

For prescription use only. The Elecsys proBNP II CalCheck is not intended to be used as a primary calibrator or routine control material.

4. Special instrument requirements:

For use with Elecsys proBNP II reagent on the Elecsys 2010/cobas e411, and MODULAR ANALYTICS E 170/cobas e 601 test systems.

## I. Device Description:

Elecsys ProBNP II CalCheck 5 set contains 5 lyophilized levels of NT-proBNP (synthetic) in a solution of human serum and has the appropriate matrix characteristics for the analyte. The reactive ingredient after reconstitution is NT-proBNP (synthetic) in human serum/buffer matrix. The human source materials were prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods were FDA approved or cleared in compliance with the European Directive 98/79/EC.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

Elecsys proBNP II CalCheck

2. Predicate 510(k) number(s):

k080147

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | For use in calibration verification and for use in the verification of the assay range established by the Elecsys proBNP II reagent on the indicated Elecsys and cobas e immunoassay analyzers | For use in the verification of the calibration established by the Elecsys proBNP II reagent on the Elecsys and cobas e immunoassay analyzers |
| Format | same | Lyophilized |
| Matrix | same | Human serum |
| Stability | same | Unopened: Store at 2-8 °C until expiration date
Reconstituted: 4 hours at 20-25 °C |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Levels | Five | Three |

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

None were referenced.

L. Test Principle:

Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range:

Not applicable

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

## Traceability and Value Assignment

The assayed value of each CalCheck level was standardized against reference standards by weighing pure synthetic NT-proBNP (1-76) amide into a human serum matrix.

Value assignment is performed for each Elecsys proBNP II CalCheck5 lot. Values are assigned for each lot of proBNP II CalCheck 5 in combination with each Elecsys proBNP II reagent lot available. Values are assigned using four Elecsys MODULAR ANALYTICS E170/cobas e601 analyzers and three Elecsys 2010/cobas e411 analyzers. Each sample is tested in duplicate. The target value for each CalCheck is the median of the observed values.

The labeling states that laboratories should establish appropriate acceptance criteria when using this product for its intended use.

## Stability

Real time and accelerated stability testing protocols and acceptance criteria were described and found to be adequate. CalCheck 5 is stable until the expiration date printed on the vial when stored unopened at $2 - 8^{\circ}\mathrm{C}$. The reconstituted vials are stable for four hours at $20 - 25^{\circ}\mathrm{C}$.

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

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3. Clinical studies:
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:
The expected values are provided in the labeling for each specific lot.

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.

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