DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR

K081789 · Siemens Healthcare Diagnostics, Inc. · JIT · Sep 10, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081789
• Device Name: DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Sep 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The ENZ I CAL is an in vitro diagnostic product for the calibration of the LDI method on the Dimension® clinical chemistry system. For prescription use only

Device Story

ENZ I CAL is a liquid, bovine serum albumin-based calibrator containing lactate dehydrogenase (chicken heart). It is used to calibrate the LDI method on the Dimension® clinical chemistry system. The product is supplied in 4 vials (2 vials of Level 2, 2 vials of Level 3). Purified water or reagent grade water is required as the Level 1 calibrator. The device is used in clinical laboratory settings by trained personnel to ensure the accuracy of quantitative lactate dehydrogenase measurements. By establishing a calibration curve traceable to the IFCC reference method, the device enables the clinical chemistry system to provide accurate patient test results, supporting clinical decision-making regarding patient health status.

Clinical Evidence

No clinical data. Substantial equivalence is based on analytical traceability to the IFCC reference method for lactate dehydrogenase.

Technological Characteristics

Liquid, bovine serum albumin-based matrix containing lactate dehydrogenase (chicken heart). Ready-to-use form. Calibrator for clinical chemistry analyzer (Dimension®). Traceable to IFCC reference method. Storage at 2-8°C.

Indications for Use

Indicated for the calibration of the lactate dehydrogenase (LDI) method on the Dimension® clinical chemistry 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

• Roche Calibrator for automated systems

Submission Summary (Full Text)

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

A. 510(k) Number:
k081789

B. Purpose for Submission:
New device

C. Measurand:
Calibrator material for lactate dehydrogenase

D. Type of Test:
Calibrator material

E. Applicant:
Siemens Healthcare Diagnostics Inc.

F. Proprietary and Established Names:
ENZ I CAL

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

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H. Intended Use:

1. Intended use(s):
See indications for use below.

2. Indication(s) for use:
The ENZ I CAL is an in vitro diagnostic product for the calibration of the LDI method on the Dimension® clinical chemistry system.

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

4. Special instrument requirements:
Dimension ® clinical chemistry system

I. Device Description:

The ENZ I CAL is a liquid bovine serum albumin based product containing lactate dehydrogenase (chicken heart). The liquid calibrator is packaged with 4 vials per carton; 2 vials of Level 2 and 2 vials of Level 3. Purified Water Diluent or reagent grade water is used as the Level 1 calibrator. The ENZ I CAL is used for the calibration of the Dimension® clinical chemistry system Lactate Dehydrogenase Flex® reagent cartridge (LDI).

J. Substantial Equivalence Information:

1. Predicate device name(s):
Roche Calibrator for Automated Systems

2. Predicate K number(s):
k990460

3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Traceability | IFCC | same |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Form | Liquid, ready to use | lyophilized |
| Matrix | Bovine serum albumin containing lactate dehydrogenase (chicken heart) | Human based containing lactate dehydrogenase (porcine heart) |

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

None referenced

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 involves preparation of anchor pools and master pools. The anchor pool is prepared from pooled normal and high human serum and is assigned by the IFCC Reference Method. LD enzyme is weighed into BSA based matrix to make (LDI) stock solution. Three levels of LDI master pools are manufactured by adding the appropriate volume of LDI stock, with a known concentration into an aqueous BSA base material. Level 1 of the LDI master pool, containing no analyte is assigned zero U/L. Levels 2 and 3 of the LDI master pool are assigned by the IFCC reference method and verified against the anchor pools using multiple Dimension instruments

Stability: ENZ I CAL is supplied as a ready to use liquid. Target shelf life for the ENZ I CAL is 12 months when stored at 2-8° C. The shelf life and open stability of the calibrator have been demonstrated using real time data. Shelf life is determined by comparing results of the product stored at 2-8° C with the

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control material stored at -20 °C and -70 °C. Recovery vs. time is monitored and percent change over time is determined with allowable drift (control vs. test): Level 2 and 3: ≤ 5%. Once the cap is removed, the assigned values are stable for 30 days when recapped immediately and stored 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

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

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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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