CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27

K062152 · Dade Behring, Inc. · JIT · Aug 16, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062152
• Device Name: CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27
• Applicant: Dade Behring, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Aug 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The Creatine Kinase MB Isoenzyme Verifier is an in vitro diagnostic product for verification of the Creatine Kinase MB Isoenzyme (CKMB) method on the Dimension® clinical chemistry system and Dimension Vista™ System.

Device Story

The CKMB Verifier is a lyophilized human serum-based product used as a calibrator/verifier for CKMB assays. It consists of three levels: Level 1 (no CKMB) and Levels 2 and 3 (containing CKMB derived from simian heart source). The product is intended for professional use in clinical laboratory settings to verify the accuracy of CKMB method performance on Dimension and Dimension Vista clinical chemistry systems. The healthcare provider reconstitutes the lyophilized material and runs it on the clinical chemistry system; the system compares the measured values against established target concentrations to ensure the assay is performing within acceptable parameters.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized human serum-based matrix containing simian heart-derived CKMB. Three-level configuration. Traceable to Dimension clinical chemistry system values. Complies with ISO 14971:2000 for risk management.

Indications for Use

Indicated for use as an in vitro diagnostic calibrator/verifier for the Creatine Kinase MB Isoenzyme (CKMB) method on Dimension® clinical chemistry and Dimension Vista™ systems.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Dimension® CKMB Verifier (K863840)

Submission Summary (Full Text)

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

A. 510(k) Number:
k062152

B. Purpose for Submission:
Clearance for new intended use

C. Measurand:
Calibrator for Creatine kinase MB isoenzyme

D. Type of Test:
Calibrator

E. Applicant:
Dade Behring, Inc.

F. Proprietary and Established Names:
Dimension Creatine Kinase MB Isoenzyme Verifier, Model DC27

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| Calibrator, Secondary (JIT) | Class II | 21 CFR 862.1150, Calibrator. | 75 CLINICAL CHEMISTRY (CH) |

H. Intended Use:

1. Intended use(s):
See Indications for Use below.

2. Indication(s) for use:
The Creatine Kinase MB Isoenzyme Verifier is an in vitro diagnostic product for verification of the Creatine Kinase MB Isoenzyme (CKMB) method on the Dimension® clinical chemistry system and Dimension Vista™ System.

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

4. Special instrument requirements:
Dimension® clinical chemistry system and Dimension Vista™ System.

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I. Device Description:

CKMB Verifier is a lyophilized human serum base product. Level 1 contains no CKMB, Levels 2 and 3 contain CKMB from a simian heart source. The kit consists of six vials, two vials per level. The volume per vial is 1.0 mL.

All human source material was tested by FDA-approved methods for the presence of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2), Hepatitis B Surface Antigen (HBsAg) and antibodies to Hepatitis C Virus (HCV) and found to be negative/non-reactive.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Creatine Kinase MB Isoenzyme Verifier

2. Predicate K number (s):
k863840

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analyte | Creatine Kinase MB Isoenzyme | Creatine Kinase MB Isoenzyme |
| Form | Lyophilized | Lyophilized |
| Traceability | Dimension® clinical chemistry system values. | Dimension® clinical chemistry system values. |
| Matrix | Human serum based product containing CKMB from simian heart source. | Human serum based product containing CKMB from simian heart source. |
| Number of levels | Three levels. | Three levels. |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Indications for Use | The Creatine Kinase MB Isoenzyme Verifier is an in vitro diagnostic product for verification of the Creatine Kinase MB Isoenzyme (CKMB) method on the Dimension® clinical chemistry system and Dimension Vista™ System. | The Creatine Kinase MB Isoenzyme Verifier is an in vitro diagnostic product for verification of the Creatine Kinase MB Isoenzyme (CKMB) method on the Dimension® clinical chemistry system. |

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

| STANDARDS |
| --- |
| Title and Reference Number |
| Medical devices - Application of risk management to medical devices (14971:2000) |
| GUIDANCE | | | |
| --- | --- | --- | --- |
| Document Title | Office | Division | Web Page |
| Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final | OIVD | | http://www.fda.gov/cdrh/ode/calibrator.html |
| Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use | | | http://www.fda.gov/cdrh/ocd/guidance/4444.html |

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.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability and Value Assignment: Purified cynomolgus monkey heart CK-MB stock solution is added to human serum based matrix. The solution is tested on a Dimension clinical chemistry system with fixed calibration parameters (coefficients) that are determined from the molar absorbidity of NADH. The commercial lot is made by taking calculated quantities of stock solution and adding to human serum base to create the target concentrations for the two calibrator levels. The concentration of each level is verified to be within acceptable range using a Dimension clinical chemistry system with fixed calibration parameters (coefficients) that are determined from the molar absorbidity of NADH.

Stability: Shelf life for the CKMB isoenzyme verifier is 12 months when stored at the recommended conditions. Reconstituted product is stable for 8 hours when stored at 4°C. Stability study protocols and acceptance criteria were described and found to be acceptable.

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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:
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.