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

Intended 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) Summary of Safety and Effectiveness for the

### ADVIA® Centaur Calibrator 30

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

A. 510(K) Number: k100293

B. Date of Preparation: January 20, 2010

C. Proprietary and Established Names:

# MAR 1 9 2D10

ADVIA Centaur systems, ADVIA Centaur Calibrator 30

D. Applicant:

Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, NY 10591

Ernest Joseph, Senior Regulatory Specialist

Office: [phone] Fax: [phone]

#### E. Regulatory Information:

ADVIA Centaur systems, ADVIA Centaur Calibrator 30

1. Regulation section: 21 CFR § 862.1150 Calibrator, Secondary

- 2. Classification: Class II
- 3. Product Code: JIT
- 4. Panel: Clinical Chemistry

#### F. Predicate Device:

The ADVIA Centaur Calibrator 30 is substantially equivalent to the ADVIA Centaur Calibrator E which was cleared under K932715/K954697

#### G. Device Description:

The ADVIA Centaur Calibrator 30 is a 2 level human plasma based solutions containing varying concentrations of Estradiol in charcoal stripped defibrinated human plasma, 0.1% Sodium azide and preservatives. The Estradiol calibrators have expected values of 35 and 2500 pg/mL.

The Cal 30 (2.0 mL/vial) is lyophilized. Storage for lyophilized cal is at 2 - 8°C until expiration date specified on label, reconstituted calibrator storage is at 2-80 up to 14 days, and on board is up to 4 hours.

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### Statement of Intended Use:

For in vitro diagnostic use in calibrating the following assays using the ADVIA Centaur® systems.

### Enhanced Estradiol (eE2) Comparison to the Predicate Device:

Similarities and Differences between the devices and the predicate are shown below:

| | Device | Predicate |
|----------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Item | ADVIA Centaur® Calibrator 30 | ADVIA Centaur® Calibrator E<br>K 932715/K954697 |
| Number of Levels | 2 | 2 |
| Form | Lyophilized | Lyophilized |
| Matrix | charcoal stripped defibrinated<br>plasma | charcoal stripped defibrinated<br>plasma |
| Intended Use | For <i>in vitro</i> diagnostic use | For <i>in vitro</i> diagnostic use |
| Storage (Lyophilized and<br>open vial) | 2°C to 8°C | 2°C to 8°C |
| Stability | Unopened - until expiration date<br>on the vial label<br><br>Opened - 14 days<br>or | Unopened - until expiration date<br>on the vial label<br><br>Opened - 14 days<br>or |

## Similarities

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| | Device | Predicate |
|--------------|--------------------------------------------------------|--------------------------------------------------------|
| Item | ADVIA Centaur® Calibrator 30 | ADVIA Centaur® Calibrator E<br>K 932715/ K954697 |
| Constituents | Estradiol, Testosterone,<br>Progesterone and Cortisol. | Estradiol, Testosterone,<br>Progesterone and Cortisol. |

# Differences

| | Device | Predicate |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | ADVIA Centaur® Calibrator 30 | ADVIA Centaur® Calibrator E<br>K 932715/ K954697 |
| Intended use | For use in calibrating the following<br>assays using the ADVIA Centaur®<br>systems:<br><br>Enhanced Estradiol (eE2) | For use in calibrating the following<br>assays using the ADVIA Centaur®<br>systems:<br><br>Estradiol, Testosterone,<br>Progesterone and Cortisol |
| Analyte Values | Enhanced Estradiol (eE2) | Estradiol, Testosterone,<br>Progesterone and Cortisol |
| Targeted Concentration of<br>levels | Low = 35 pg/mL<br>High = 2500 pg/mL | Low = 120 pg/mL<br>High = 1450 pg/mL |

## Performance:

The traceability, value assignment, and stability of the ADVIA Centaur® Calibrator 30 have been
validated following procedures of Siemens Healthcare Diagnostics.

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## Conclusions:

The ADVIA Centaur Calibrator 30 is substantially equivalent to previously cleared ADVIA
Centaur Calibrator E.

:

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the snakes intertwined around a staff.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Siemens Healthcare Diagnostics Inc. c/o Ernest Joseph Senior Regulatory Specialist 511 Benedict Avenue Tarrytown, NY 10591

Har 1 9 2010

Re: k100293

> Trade Name: ADVIA Centaur Calibrator 30 Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator, Secondary Regulatory Class: Class II Product Codes: JIT Dated: January 31, 2010 Received: February 2, 2010

Dear Mr. Joseph:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

CA

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indication for Use

510(k) Number (if known): Device Name: ADVIA Centaur Ca Indication for Use:

For in vitro diagnostic use in calibrating the following assays using 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.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) jk/00293

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