ELECSYS CK-MB CALCHECK 5

K093582 · Roche Diagnostics · JJX · Mar 29, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093582
• Device Name: ELECSYS CK-MB CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 29, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Elecsys CK-MB 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 CK-MB reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys CK-MB CalCheck 5 is an assayed quality control material used to verify calibration and assay range for CK-MB reagent on Elecsys and cobas e immunoassay analyzers. Used by laboratory professionals in clinical settings to ensure analytical performance of immunoassay systems. Provides a reference point for verifying that the instrument's measurement range remains within established specifications, supporting accurate clinical diagnostic testing for cardiac markers.

Clinical Evidence

No clinical data. Bench testing only. Stability testing (real-time and accelerated) confirmed 24-month shelf life at 2-8°C and 4-hour stability post-reconstitution at 20-25°C. Value assignment performed using multiple analyzers (Elecsys 2010/cobas e411 and Modular Analytics E170/cobas e601) with duplicate testing; target values determined by median observed values.

Technological Characteristics

Lyophilized human serum matrix spiked with human CK-MB. Five-level concentration set (Level 1: ≤ 0.3 ng/mL; Level 2: 5 ng/mL; Level 3: 100 ng/mL; Level 4: 400 ng/mL; Level 5: 500 ng/mL). Standardized using internal master calibrators traceable to AACC human recombinant standardization material. Storage: 2-8°C unopened; 20-25°C for 4 hours reconstituted.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys CK-MB 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.

Submission Summary (Full Text)

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

A. 510(k) Number:
k093582

B. Purpose for Submission:
New device

C. Measurand:
Calibration verification and assay range verification material for CK-MB (MB isoenzyme of creatine kinase)

D. Type of Test:
Not applicable

E. Applicant:
Roche Diagnostics

F. Proprietary and Established Names:
Elecsys CK-MB 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:

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Clinical Chemistry

H. Intended Use:

1. Intended use(s):

See indications for use below.

2. Indication(s) for use:

The Elecsys CK-MB 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 CK-MB reagent on the indicated Elecsys and cobas e immunoassay analyzers.

3. Special conditions for use statement(s):

The Elecsys CK-MB CalCheck 5 is not intended to be used as a primary calibrator or routine control material.

4. Special instrument requirements:

The labeling states that the CalChecks are for use with the Elecsys CK-MB reagent on the Elecsys 2010/cobas e411 and Modular Analytics E170/cobas e601 test systems.

I. Device Description:

The Elecsys CK-MB CalCheck 5 is a lyophilized product consisting of human CK-MB in human serum matrix. During manufacture, the CK-MB is spiked into the matrix at the target concentrations listed below. CalCheck Level 1 contains no analyte.

| Elecsys CK-MB CalCheck level | Target Value (ng/mL) |
| --- | --- |
| Level 1 | ≤ 0.3 |
| Level 2 | 5 |
| Level 3 | 100 |
| Level 4 | 400 |
| Level 5 | 500 |

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 applied were FDA-approved or cleared in compliance with the European Directive 98/79/EC, Annex II, List A.

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J. Substantial Equivalence Information:

1. Predicate device name(s):
Elecsys CalCheck CK-MB

2. Predicate K number(s):
k963182

3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Indications for use | same | For use in calibration verification and for use in the verification of the assay range for CK-MB assay |
| Composition | same | Lyophilized human serum matrix spiked with human CK-MB |
| Stability | same | Unopened: Store at 2-8°C until expiration date
Reconstituted: 4 hrs at 20 – 25°C. |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Levels | 5 | 3 |
| Preparation and handling | Reconstitute Check 1, Check 2, Check 3, Check 4, and Check 5 with exactly 1.0 mL distilled or deionized water. Allow to stand closed for 15 minutes, then mix gently by inversion. | Reconstitute Check 1 and Check 2 with exactly 1.0 mL distilled or deionized water. Reconstitute Check 3 with exactly 1.5 mL distilled or deionized water. Allow to stand closed for 15 minutes, then mix gently by inversion. |

K. Standard/Guidance Document Referenced (if applicable):
None referenced.

L. Test Principle:
Not applicable.

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M. Performance Characteristics (if/when applicable):

1. Analytical performance:
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
Elecsys CK-MB CalCheck 5 is standardized using internally produced master calibrators which are traceable to AACC human recombinant standardization material.
Each of the five CalCheck levels is value assigned using a minimum of three Elecsys 2010/cobas e411 analyzers and Modular Analytics E170/cobas e 601 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 for 24 months when stored unopened at 2 – 8°C. Real time testing will continue to support stability for 36 months. The reconstituted vials are stable up to four hours at 20-25°C.
d. Detection limit:
Not applicable
e. Analytical specificity:
Not applicable
f. Assay cut-off:
Not applicable

2. Comparison studies:

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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:
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.