ELECSYS DIGOXIN CALCHECK 5

K102044 · Roche Diagnostics · JJX · Aug 31, 2010 · Clinical Chemistry

Device Facts

• Record ID: K102044
• Device Name: ELECSYS DIGOXIN CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 31, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Elecsys Digoxin 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 Digoxin reagent on the indicated Elecsys and cobas e immunoassay analyzers. For prescription use only.

Device Story

Elecsys Digoxin CalCheck 5 is an in vitro diagnostic control set containing 5 levels of Digoxin in a bovine serum matrix; used for calibration verification and assay range verification on Roche immunoassay analyzers. Device provides 5 concentration levels (0 to 5 ng/mL) to verify instrument performance across the assay range. Healthcare providers use the output to confirm that the analyzer's calibration remains valid and that the assay is performing within established specifications. This ensures the accuracy of patient Digoxin test results, which is critical for therapeutic drug monitoring and preventing toxicity.

Clinical Evidence

No clinical data. Bench testing only. Performance was established through value assignment using a master calibration curve on the Elecsys 2010 analyzer, verified across multiple MODULAR ANALYTICS E170 / cobas e 601 analyzers. Stability studies confirmed 18-month shelf life at 2-8°C and 6-hour open-vial stability at 20-25°C.

Technological Characteristics

Liquid product; bovine serum matrix; five concentration levels; stored at 2-8°C; opened stability 6 hours at 20-25°C. Analyte: Digoxin. Used on Elecsys and cobas e immunoassay analyzers.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys Digoxin reagent on Roche Elecsys 2010 / cobas e 411 and MODULAR ANALYTICS E170 / cobas e 601 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 Digoxin CalCheck (k973973)

Submission Summary (Full Text)

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

A. 510(k) Number:
k102044

B. Purpose for Submission:
New device

C. Measurand:
Calibration verification and assay range verification for Elecsys Digoxin CalCheck 5

D. Type of Test:
Not applicable

E. Applicant:
Roche Diagnostics

F. Proprietary and Established Names:
Elecsys Digoxin CalCheck 5

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:

The Elecsys Digoxin 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 Digoxin reagent on the indicated Elecsys and cobas e immunoassay analyzers

3. Special conditions for use statement(s):

For prescription use only

4. Special instrument requirements:

Roche Elecsys 2010 / cobas e 411 and MODULAR ANALYTICS E170 / cobas e 601 immunoassay analyzers

I. Device Description:

Elecsys Digoxin CalCheck 5 set is an in vitro diagnostic device that contains 5 levels of Digoxin in a buffer/protein (bovine serum) matrix. The vials contain 2.0 mL each and are packaged in sets of 5.

| Level | Target Value (ng/mL) | Target Range (ng/mL) |
| --- | --- | --- |
| Check 1 | ≤ 0.3 | ≤ 0.3 |
| Check 2 | 1.5 | 1.35 - 1.65 |
| Check 3 | 2.5 | 2.25 - 2.75 |
| Check 4 | 4 | 3.8 - 4.2 |
| Check 5 | 5 | 4.8 - 5.2 |

J. Substantial Equivalence Information:

1. Predicate device name(s):

Elecsys Digoxin CalCheck

2. Predicate K number(s):

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k973973

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Indications for Use | Same | For use in the verification of the calibration established by the Elecsys Digoxin reagent on the indicated Elecsys and cobas e immunoassay analyzers. |
| Analyte Reagent | Same | Digoxin |
| Format | Same | Liquid |
| Handling | Same | Mix gently by inversion to ensure homogeneity |
| Matrix | Same | Bovine serum matrix |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Levels | Five | Three |
| Stability | Unopened: • Store at 2-8°C until expiration date Opened: • 20-25°C: 6 hours | Unopened: • Store at 2-8°C until expiration date Opened: • 15-25°C: 5 hours |

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

Guidance for Industry and FDA Staff – Assayed and Unassayed Quality Control Material

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):

Traceability and Value Assignment

A Master calibration curve generated on the Elecsys 2010 analyzer is used to calculate ng/mL digoxin in each CalCheck for value assignment. Each master calibrator is standardized by weighing USP Digoxin reference material into analyte-free bovine serum.

For each Elecsys Digoxin CalCheck 5 lot manufactured, the CalChecks are assayed in duplicate on at least three MODULAR ANALYTICS E170 / cobas e 601 analyzers (master platform). The assigned value of each CalCheck is defined as the median value obtained over at least 6 determinations (duplicate runs on at least 3 analyzers) of the respective CalCheck. The assigned range is calculated as ±27% of the assigned value for levels 2-4 and ±30% of the assigned value for level 5. The label states that each laboratory should establish appropriate acceptance criteria when using this product for its intended use.

To ensure the values assigned using the master platform are transferrable and valid for the other instrument platforms, each Elecsys Digoxin CalCheck 5 level is assayed once a day on 8 Elecsys 2010 / cobas e 411 analyzers for 1 day. The median value for the 8 analyses must be within 10% of the master platform assigned value. After this acceptance criterion is met, the assigned values from the master platform are deemed valid for the Elecsys 2010 / cobas e 411 immunoassay analyzers.

Stability

Open-vial and accelerated stability study protocols and acceptance criteria were described. As stability studies are not analyzer dependent, all stability studies were performed on the Elecsys 2010 / cobas e 411 immunoassay analyzer and can be applied to the MODULAR ANALYTICSE170 / cobas e 601 analyzers. The data support the package insert claims that open-vial Elecsys Digoxin CalCheck 5 is stable for up to 6 hours at 20-25°C, and that storage at 2-8°C provides stability for 18 months. The expiration date listed on each CalCheck bottle label reflects this stability time of 18 months. A real-time stability study is ongoing.

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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:
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:

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There are 5 levels of the CalCheck 5 kit which span the 0-5 ng/mL measuring range of the Digoxin assay (see Device Description under section I). The final assigned values are lot specific and are provided in the labeling.

Dilution Studies were performed where CalCheck 1 & CalCheck 2, and CalCheck 4 & CalCheck 5 were mixed in a 1:1 ratio (as instructed in the draft package insert for dilutions) and measured in two-fold determination. The Digoxin CalCheck 5 dilution values were within the assay measuring range after dilution.

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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