DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350

K083462 · Siemens Healthcare Diagnostics · JIT · Feb 27, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083462
• Device Name: DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JIT · Clinical Chemistry
• Decision Date: Feb 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The Enzyme 5 Calibrator (ENZ 5 CAL) is an in vitro diagnostic product for the calibration of the lactate dehydrogenase (LDI) method on the Dimension Vista® System.

Device Story

ENZ 5 CAL is a liquid, bovine serum albumin-based calibrator containing lactate dehydrogenase derived from chicken heart. It is designed for use on the Dimension Vista® System to calibrate the lactate dehydrogenase (LDI) assay. The product consists of a single level (Calibrator A) and is used in conjunction with system water as the zero-level calibrator. It is intended for professional use in clinical laboratory settings. The calibrator ensures the accuracy and traceability of the LDI method to the IFCC reference measurement procedure, supporting clinical decision-making by providing reliable quantitative results for patient lactate dehydrogenase levels.

Clinical Evidence

No clinical data. Performance is supported by bench testing, including stability studies (shelf-life, open-vial, and punctured-vial stability) and value assignment verification against IFCC reference measurement procedures.

Technological Characteristics

Liquid, bovine serum albumin-based matrix; contains lactate dehydrogenase from chicken heart, preservatives, and stabilizers. Single-level calibrator (Calibrator A). Traceable to IFCC LD reference method at 37°C. Designed for use on the Dimension Vista® System.

Indications for Use

Indicated for the calibration of the lactate dehydrogenase (LDI) method on the Dimension Vista® System for in vitro diagnostic 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® clinical system Enzyme I Calibrator (k081789)

Submission Summary (Full Text)

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

A. 510(k) Number:
k083462

B. Purpose for Submission:
New device

C. Measurand:
Calibrator material for lactate dehydrogenase

D. Type of Test:
Not applicable.

E. Applicant:
Siemens Healthcare Diagnostics Inc.

F. Proprietary and Established Names:
Dimension Vista® System Enzyme 5 Calibrator (ENZ 5 CAL)

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1150 Calibrator
2. Classification:
Class II
3. Product code:
JIT, Calibrator, Secondary
4. Panel:
Clinical Chemistry (75)

H. Intended Use:
1. Intended use(s):
The ENZ 5 CAL is an in vitro diagnostic product for the calibration of the lactate dehydrogenase (LDI) method on the Dimension Vista® System.
2. Indication(s) for use:
See Intended Use section above.
3. Special conditions for use statement(s):
For prescription use only
4. Special instrument requirements:
Dimension Vista® System

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I. Device Description:

ENZ 5 CAL is a liquid, bovine serum albumin-based product containing lactate dehydrogenase from chicken heart. The calibrator consists of one level (Calibrator A), and comes packaged with three vials at 1.5 mL per vial. System water (the zero level calibrator) does not come packaged with the calibrator. The calibrator contains preservatives and stabilizers.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Dimension® clinical system Enzyme I Calibrator

2. Predicate 510(k) number(s):
k081789

Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Proposed Device | Predicate Device |
| Analyte | Lactate dehydrogenase. | same |
| Intended use | For the calibration of the lactate dehydrogenase (LDI) method on the Dimension Vista® System. | For the calibration of the lactate dehydrogenase (LDI) method on the Dimension® clinical chemistry system. |
| Matrix | Liquid bovine serum albumin base with lactate dehydrogenase of chicken liver origin. | same |
| Form | Liquid | same |
| Traceability | IFCC LD at 37 °C primary reference method. | same |
| Differences | | |
| --- | --- | --- |
| Item | Proposed Device | Predicate Device |
| Packaging | One Level – Calibrator A | Two Levels – Level 2 and Level 3 |
| Calibration Levels | Two Levels: System water is Level 1 Calibrator A is Level 2 | Three Levels: Purified Water Diluent or reagent grade water is Level 1 Level 2 Calibrator Level 3 Calibrator |

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

Guidance:

- Guidance for Industry – Abbreviated 510 (k) Submissions for In Vitro Diagnostic Calibrators; February 22, 1999

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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: The calibrator is traceable to the IFCC lactate dehydrogenase (LD) Reference Measurement Procedure

Value Assignment: The expected value of the commercial calibrator, Calibrator A, is assigned by measuring the recovery of the calibrator using three instruments (Dimension Vista® System) and three lactate dehydrogenase method (LDI) reagent lots. A previously assigned commercial lot is used as the control for the assignment for the new commercial lot.

Stability: Target shelf life for the Dimension Vista® ENZ 5 CAL is 12 months at 2-8°C. Shelf life is determined by comparing results of the product stored at 2-8°C with the control material stored at -20 °C and -70 °C. Shelf life is also tested following three freeze-thaw cycles and three different stress testing routines. Real time and freeze-thaw stability testing is on-going.

The open vial stability for the Dimension Vista® ENZ 5 CAL is 30 days at 2-8°C. The punctured vial stability of the Dimension Vista® ENZ 5 CAL is 7 days at 2-8°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: 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.

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