DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360

K083579 · Siemens Healthcare Diagnostics · JIX · Feb 20, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083579
• Device Name: DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JIX · Clinical Chemistry
• Decision Date: Feb 20, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The ENZ 6 CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension Vista® System. For prescription use. For use with the Siemens Dimension Vista® System

Device Story

The Dimension Vista® Enzyme 6 Calibrator is a liquid, multi-analyte, human serum albumin-based product containing human-source creatine kinase and porcine-source creatine kinase MB. It is used in clinical laboratory settings to calibrate CKI and MBI methods on the Dimension Vista® System. The calibrator kit consists of three vials of Calibrator A; purified water or reagent-grade water is used as Calibrator Level 1. By establishing a known reference point for the assay, the calibrator enables the system to accurately quantify analyte concentrations in patient samples, supporting clinical decision-making regarding cardiac or muscle-related conditions.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including manufacturing process validation, value assignment, and stability testing.

Technological Characteristics

Liquid, multi-analyte calibrator; human serum albumin matrix; contains human-derived CKMM and porcine-derived CKMB. Traceable to IFCC reference methods/materials. Storage: -20°C shelf life; 2-8°C after opening. Designed for use with Siemens Dimension Vista® System.

Indications for Use

Indicated for the calibration of Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension Vista® System for clinical laboratory use.

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® CKI/MBI Calibrator (k081731)

Submission Summary (Full Text)

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

A. 510(k) Number:
k083579

B. Purpose for Submission:
New device

C. Measurand:
Creatine Kinase, Creatine Kinase MB fraction

D. Type of Test:
Calibrator

E. Applicant:
Siemens Healthcare Diagnostics Inc.

F. Proprietary and Established Names:
Dimension Vista® Enzyme 6 Calibrator

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1150, Calibrator
2. Classification:
Class II (calibrator)
3. Product code:
JIX, Calibrator, Multi-Analyte Mixture
4. Panel:
Clinical Chemistry (75)

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H. Intended Use:

1. Intended use(s):

See Indication(s) for use below.

2. Indication(s) for use:

The ENZ 6 CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension Vista® System.

3. Special conditions for use statement(s):

For prescription use.

4. Special instrument requirements:

For use with the Siemens Dimension Vista® System

I. Device Description:

The Dimension Vista® System Enzyme 6 Calibrator (Enz 6 CAL) is a liquid, multi-analyte, human serum albumin based product containing creatine kinase MM (human source) and creatine kinase MB (porcine source). The kit consists of three vials of Calibrator A, 2.0 ml per vial.

Contains human source material. Each donor unit used in the preparation of this product was tested by FDA-approved methods for the presence of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2), as well as for Hepatitis B Surface Antigen (HBSAg) and antibody to Hepatitis C Virus (HCV), and found to be negative (not repeatedly reactive). Because no testing can offer complete assurance that these or other infectious agents are absent, this material should be handled using good laboratory practice to avoid skin contact and ingestion.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Dimension® CKI/MBI Calibrator

2. Predicate K number(s):

k081731

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analyte | Creatine kinase (human source) and creatine kinase-MB (porcine source) | Creatine kinase (human source) and creatine kinase-MB (porcine source) |
| Matrix | Human serum albumin | Human serum albumin |
| Form | Liquid | Liquid |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | The ENZ 6 CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI*) and Creatine Kinase MB (MBI*) methods on the Dimension Vista® System. | The CKI/MBI CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension® clinical chemistry system. |
| Levels | CKI – One level | CKI - Two levels |
| | MBI – One level | MBI – Two levels |

* CKI and MBI are the sponsor's nomenclature to indicate that the devices are traceable to IFCC Reference material. See section M.1.c.

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

FDA Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final

L. Test Principle:

Not Applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not Applicable

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b. Linearity/assay reportable range:

Not Applicable

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

The Dimension Vista® Enzyme 6 Calibrator is a one level calibrator containing CK (CKMM) and CKMB. The zero level calibrator is deionized water which is provided by the user. Both CKI and MBI are traceable to IFCC Reference methods or materials.

Traceability:

The sponsor prepares an Anchorpool by combining normal and high levels of Creatine Kinase from human serum. The value for this pool is assigned by analyzing it using the IFCC Reference Method.

Masterpools for CK or CKMB are created using gravimetrically prepared CK or CKMB stock solutions added to the sponsor's base material to establish prespecified concentrations of the analytes. Value assignments for the CKI Masterpools are determined using the IFCC Reference Method and verified against the Anchorpool using multiple Dimension instruments, testing 45 replicates. CKMB Masterpool values are assigned from IFCC reference standard ERM AD455/IFCC calibration curves using multiple instruments, testing multiple replicates.

CKI and CKMB antigens are added gravimetrically to the stock base at appropriate amounts to the target calibrator levels. Final bottle values are assigned against Masterpools using multiple instruments and reagent lots.

Stability: The shelf life, open and punctured vial stabilities of the CKI MBI calibrator have been demonstrated using real time data. The predetermined acceptance criteria and protocols were reviewed and found to be acceptable. The CKI/MBI calibrator has a target shelf life of 12 months when stored at -20°C. The calibrator must be thawed at room temperature before use. Once the cap is removed, or punctured, the assigned values are stable for 7 days when recapped immediately and stored at 2-8 °C.

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

f. Assay cut-off:

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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.