ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810

K100293 · Siemens Heatlhcare Diagnostics, Inc. · JIT · Mar 19, 2010 · Clinical Chemistry

Device Facts

• Record ID: K100293
• Device Name: ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810
• Applicant: Siemens Heatlhcare Diagnostics, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Mar 19, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

For in vitro diagnostic use in calibrating the following assays using the ADVIA Centaur® systems. Enhanced Estradiol (eE2) ADVIA Centaur calibrator 30 is a device intended for medical purposes for use in Estradiol Assay to establish points of reference that are used in the determination of values in the measurement of Estradiol in human serum, Heparinized and EDTA Plasma.

Device Story

ADVIA Centaur Calibrator 30; 2-level human plasma-based solution; contains USP Estradiol, Testosterone, Cortisol, and Progesterone; spiked in charcoal-stripped defibrinated human plasma with 0.1% Sodium azide. Used in clinical laboratory settings on ADVIA Centaur and ADVIA Centaur XP systems. Calibrator establishes reference points for Estradiol assay value determination. Healthcare providers use assay results for clinical decision-making regarding patient hormone levels. Lyophilized format; requires reconstitution; stored at 2°C to 8°C.

Clinical Evidence

No clinical data. Performance validation focused on traceability, value assignment, and stability testing conducted by the manufacturer.

Technological Characteristics

Lyophilized human plasma matrix; contains USP Estradiol, Testosterone, Cortisol, Progesterone, and 0.1% Sodium azide. Calibrator levels: 35 and 2500 pg/mL. Traceability to internal standards value-assigned via ID-GC/MS. System compatibility: ADVIA Centaur and ADVIA Centaur XP. Storage: 2°C to 8°C.

Indications for Use

Indicated for in vitro diagnostic calibration of the Enhanced Estradiol (eE2) Assay in human serum, Heparinized, and EDTA plasma samples.

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

• ADVIA Centaur Calibrator E (k954697)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k100293

B. Purpose for Submission:
New device

C. Measurand:
Calibration materials for estradiol assay

D. Type of Test:
Not applicable

E. Applicant:
Siemens Healthcare Diagnostics Inc.

F. Proprietary and Established Names:
ADVIA Centaur systems, ADVIA Centaur Calibrator 30

G. Regulatory Information:

1. Regulation section:
21 CFR 862.1150 Calibrator, Secondary

2. Classification:
Class II

3. Product code:
JIT

4. Panel:
Clinical Chemistry (75)

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H. Intended Use:

1. Intended use(s):

See indications for use below.

2. Indication(s) for use:

For in vitro diagnostic use in calibrating the Enhanced Estradiol (eE2) Assay. ADVIA Centaur calibrator 30 is a device intended for medical purposes for use in Estradiol Assay to establish points of reference that are used in the determination of values in the measurement of Estradiol in human serum, Heparinized and EDTA Plasma.

3. Special conditions for use statement(s):

For prescription use only.

4. Special instrument requirements:

ADVIA Centaur and ADVIA Centaur XP systems.

I. Device Description:

The ADVIA Centaur® Calibrator 30 is a 2 level human plasma based solutions containing varying concentrations of USP Estradiol, Testosterone, Cortisol and Progesterone spiked in charcoal stripped defibrinated human plasma, 0.1% Sodium azide and preservatives. All human source materials used in the manufacture of this product was tested by FDA-approved methods and found nonreactive for hepatitis B surface antigen (HBsAg), antibody to hepatitis C (HCV), and antibody to HIV-1/2, The Estradiol calibrators have expected values of 35 and 2500 pg/mL. ADVIA Centaur Calibrator 30 (2.0 mL/vial) is lyophilized.

J. Substantial Equivalence Information:

1. Predicate device name(s):

ADVIA Centaur Calibrator E

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

k954697

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | same | For use as a calibration material for the ADVIA Centaur® systems: |
| Form | same | Lyophilized |
| Matrix | same | charcoal stripped defibrinated plasma |
| Intended Use | same | For in vitro diagnostic use |
| Storage (Lyophilized and open vial) | same | 2°C to 8°C |
| Stability | same | Unopened – until expiration date on the vial label
Opened - 14 days
or
On-board - 4 hours |
| Constituents | same | Estradiol, Testosterone, Progesterone and Cortisol. |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analyte Values | Estradiol | Estradiol, Testosterone, Progesterone and Cortisol |
| Targeted Concentration of levels | Low = 35 pg/mL
High = 2500 pg/mL | Low = 120 pg/mL
High = 1450 pg/mL |

K. Standard/Guidance Document Referenced (if applicable):
FDA Guidance Document: Abbreviated 510(K) submissions for In Vitro Diagnostic Calibrators (1999).
FDA Guidance Document: Format for Traditional and Abbreviated 510(K)s (2005).

L. Test Principle:
Not applicable.

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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

A set of internal Estradiol standards (primary calibrators), which are not traceable to an international standard, are value assigned using panel of ID-GC/MS value assigned real serum samples. Each production lot of Estradiol calibrators (secondary calibrators) are value assigned against these internal standards. Primary calibrator values are then calculated from full curve data reduction for each system independently. The average dose recovered for each calibrator assigns their value. Quality control is performed by calculating the recovery of controls using the calibrator values. These controls must fall within set specifications. The internal standards are stored frozen and checked periodically against the panel of these serum samples to confirm stability.

Production lots of secondary estradiol calibrators are value assigned against primary standards using one reagent lot, one run on three different instruments. Estradiol calibrator values are derived using four-parameter weighted data algorithm reduction for each run on each instrument. Calibrator values are then averaged across all systems. Three levels of commercially available controls and three levels of human serum based Medical Decision Pools at 60, 450 and 1500 pg/mL are used to validate value assignment.

Stability

Real time, accelerated, open vial and on board stability testing protocols and acceptance criteria were described and found to be adequate. The current closed vial stability claim is 16 months at 2° to 8°C; however it will be updated as additional real time stability data becomes available. The reconstituted vials are stable for fourteen days at 2 to 8°C or for four hours at 25°C.

d. Detection limit:
Not applicable

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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:
The expected values are provided in the labeling for each specific lot.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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