LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621

K081683 · Siemens Healthcare Diagnostics · JIT · Jul 7, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081683
• Device Name: LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jul 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The LOCI® TNI Calibrator is an in vitro diagnostic product for the calibration of the Cardiac Troponin I (TNI) method on the Dimension® EXL™ integrated chemistry system with LOCI® module.

Device Story

LOCI® Cardiac Troponin I Calibrator is a liquid, frozen, human serum-based product containing native human troponin complex. Used in clinical laboratory settings to calibrate the Cardiac Troponin I method on the Dimension® EXL™ integrated chemistry system. Calibrator levels are assigned values ranging from 0 to 43 ng/mL. Healthcare professionals use the device to ensure the accuracy and traceability of the Troponin I assay, which aids in the clinical assessment of cardiac conditions.

Clinical Evidence

No clinical data. Bench testing only. Stability demonstrated via real-time data from 3 lots; shelf-life established at 12 months at -20°C, with 24-hour open-vial stability at 2-8°C. Value assignment validated against master pools and anchor pools using the Siemens Stratus CS analyzer.

Technological Characteristics

Liquid, frozen human serum-based calibrator. Contains native human troponin complex. Traceable to an internal master pool. Designed for use with the Dimension® EXL™ integrated chemistry system with LOCI® module. No specific materials or software algorithm classes are detailed beyond the chemical composition for calibration.

Indications for Use

Indicated for the calibration of the Cardiac Troponin I (TNI) assay on the Dimension® EXL™ integrated chemistry system with LOCI® module. No specific patient population, age, or gender restrictions are defined for this in vitro diagnostic calibrator.

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 Vista® Cardiac Troponin I Calibrator (K053577)

Submission Summary (Full Text)

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

A. 510(k) Number:
k081683

B. Purpose for Submission:
New device

C. Measurand:
Calibrator materials for Cardiac Troponin I

D. Type of Test:
Not applicable

E. Applicant:
Siemens Healthcare Diagnostics Inc.

F. Proprietary and Established Names:
LOCI® Cardiac Troponin I Calibrator

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

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H. Intended Use:

1. Intended use(s):

See Indication for use below.

2. Indication(s) for use:

The LOCI® TNI Calibrator is an *in vitro* diagnostic product for the calibration of the Cardiac Troponin I (TNI) method on the Dimension® EXL™ integrated chemistry system with LOCI® module.

3. Special conditions for use statement(s):

For prescription use

4. Special instrument requirements:

For use with Dimension® EXL™ integrated chemistry system with LOCI® module.

I. Device Description:

The LOCI® Cardiac Troponin I Calibrator is a liquid, frozen, human serum based product containing native human troponin complex with other components designed to stabilize the product. The calibrator levels and their assigned values are:

| | Level 1 | Level 2 | Level 3 | Level 4 | Level 5 |
| --- | --- | --- | --- | --- | --- |
| TNI | 0 ng/mL | 0.60 ng/mL | 6 ng/mL | 20 ng/mL | 43 ng/mL |

The human blood used in the manufacture of these calibrators has been tested using FDA approved methods and found to be non-reactive for HBsAg and antibodies to HCV and HIV-1/2.

J. Substantial Equivalence Information:

1. Predicate device names(s):

Dimension Vista Cardiac Troponin I Calibrator

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

k053577

3. Comparison with predicate:

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| Similarities and Differences | | |
| --- | --- | --- |
| Item | Dimension Vista Cardiac Troponin I Calibrator (predicate device) | LOCI Cardiac Troponin I Calibrator (candidate device) |
| Intended Use | The CTNI CAL is an in vitro diagnostic product for the calibration of Cardiac Troponin I (CTNI) on the Dimension Vista system | The LOCI TNI CAL is an in vitro diagnostic product for the calibration of the Cardiac Troponin I (TNI) method on the Dimension® EXL™ integrated chemistry system with LOCI module |
| Analyte and Matrix | Human troponin complex in human serum matrix | Same |
| Forms | Liquid, frozen form | Same |
| Calibrator levels | 6 levels | 5 levels |
| Traceability | The calibrator is traceable to an internal master pool containing human cardiac troponin complex | Same |

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

None were 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

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

Traceability and Value Assignment:

Traceability and value assignment for LOCI Troponin I calibrators involves preparation of anchor pools and master pools. The master pools are used to assign individual calibrator lots.

The anchor pools are a 6-level set of primary reference calibrators. They are prepared from native human sera and are assigned values using the Siemens Stratus CS analyzer. The master pools are prepared from a normal human serum pool spiked with human troponin complex to the appropriate concentrations. Values for the Master Pool are derived by multiple analyses against the Anchor Pool calibration curve. Each lot of the LOCI® Cardiac Troponin I Calibrator is prepared the same manner as the master pool and the value assignment is established by measurement against the Master Pool calibration.

Stability: The shelf-life and open-vial stability of the LOCI Cardiac Troponin I Calibrator have been demonstrated using real time data collected from 3 lots of calibrators. The predetermined acceptance criteria and protocols were reviewed and found to be acceptable.

For the LOCI Cardiac Troponin I Calibrator, the sponsor claims a shelf life of 12 months when unopened and stored at -20°C. Once thawed and opened, the calibrator is stable for 24 hours when 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

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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:
The assigned values are printed in the labeling of the calibrator materials.

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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