ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS

K091123 · Siemens Healthcare Diagnostics · JJX · Aug 14, 2009 · Clinical Chemistry

Device Facts

• Record ID: K091123
• Device Name: ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 14, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The ADVIA® Centaur DHEAS Master Curve Material are for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA® Centaur Systems Dehydroepiandrosterone sulfate (DHEAS) assay.

Device Story

ADVIA Centaur DHEAS Master Curve Materials (MCM) consist of 5 levels of DHEAS concentrations (0, 60, 300, 900, 1500 µg/dL) in delipidated, steroid-stripped, human defibrinated plasma. Used in clinical laboratory settings to verify calibration and reportable range of the ADVIA Centaur DHEAS assay. Liquid, ready-to-use format. Healthcare professionals use the output to confirm assay performance within the reportable range. Benefits include ensuring accuracy of patient DHEAS test results.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time and accelerated) support 18-month unopened shelf life and 60-day open-vial stability at 2-8°C. Value assignment performed using ADVIA Centaur analyzers and reference lots.

Technological Characteristics

Liquid, human defibrinated plasma matrix, steroid-stripped, delipidated. Five concentration levels. Traceable to internal standard using purified DHEAS. Storage 2-8°C.

Indications for Use

Indicated for in vitro diagnostic use to verify calibration and reportable range of the ADVIA Centaur Systems Dehydroepiandrosterone sulfate (DHEAS) assay.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• VALIDATE Thyroid Calibration Verification Test Set (K062501)

Submission Summary (Full Text)

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K091123

## 510(k) Summary

| Submitter information<br>Contact person: | Clare Santulli<br>Sr. Regulatory Technical Specialist | | |
|-----------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------|--------------|
| Address: | Siemens Healthcare Diagnostics<br>511 Benedict Avenue<br>Tarrytown, NY 10591-5097 | | AUG 1 4 2009 |
| Phone: | 914-524-2701<br>914-524-3579 (fax) | | |
| Date summary prepared: | | June 11, 2009 | |
| Device Trade or Proprietary Name: | | ADVIA® Centaur DHEAS Master Curve<br>Material | |
| Device Common/Usual Name or<br>Classification Name: | | Single (Specified) Analyte Controls (Assayed And<br>Unassayed) | |
| Classification Number/Class: | | JJX / Class I | |
| Classification Panel: | | Clinical Chemistry (75) | |

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

The assigned 510(k) number is: K091123

## Predicate Devices:

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| Device Name | VALIDATE Thyroid Calibration Verification Test Set |
|---------------|----------------------------------------------------|
| Common name | VALIDATE THY Calibration Verification Test Set |
| 510(k) Number | K062501 |
| Manufacturer | Maine Standards Company |

Siemens Healthcare Diagnostics ADVIA Centaur DHEAS Master Curve Materials Premarket Notification - Abbreviated 510(K) 510(k) Summary

.

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### Device Description:

The ADVIA® Centaur DHEAS Master Curve Material are 5 levels of varying concentrations of DHEAS in delipidated, steroid stripped, human defribrinated plasma with preservative. The MCM Master Curve Materials have expected values (lot specific) of 0, 60, 300, 900 and 1500 ug/dL.

The MCM Master Curve Material (1.0 mL/vial) are liquid and ready to use. Storage is at 2 - 8ºC.

CAUTION! POTENTIAL BIOHAZARD: Contains human source material. While each human serum or plasma donor unit used in the manufacture of this product was tested by FDAapproved methods and found nonreactive for hepatitis B surface antigen (HBsAg), antibody to hepatitis C (HCV), and antibody to HIV-1/2, all products manufactured using human source material should be handled as potentially infectious. Because no test method can offer complete assurance that hepatitis B or C viruses, HIV, or other infectious agents are absent, these products should be handled according to established good labor atory practices.

### Statement of Intended Use:

The ADVIA® Centaur DHEAS Master Curve Material are for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA® Centaur Systems Dehydroepiandrosterone sulfate (DHEAS) assay.

#### Performance:

The traceability, value assignment, and stability of the ADVIA® Centaur DHEAS Master Curve Materials have been validated following procedures of Siemens Healthcare Diagnostics. These DHEAS Master Curve Material are substantially equivalent to currently marketed devices with similar intended uses.

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## Comparison to the Predicate Device:

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

| Item | Device | Predicate |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ADVIA® DHEAS Master Curve<br>Material | Maine Standards Company<br>VALIDATE Thyroid Calibration<br>Verification Test Set<br>(K062501) |
| Intended Use | The ADVIA® Centaur DHEAS<br>Master Curve Material are for <i>in vitro</i> diagnostic use in the<br>verification of calibration and<br>reportable range in the ADVIA<br>Centaur® Systems<br>Dehydroepiandrosterone<br>sulfate (DHEAS) assay. | The VALIDATE Thyroid<br>Calibration Verification Test Set<br>solutions are for <i>in vitro</i><br>diagnostic use in the quantitative<br>determination of linearity,<br>calibration verification and<br>verification of reportable range in<br>automated, semi-automated and<br>manual chemistry systems. |
| Form | Liquid | Liquid |
| Analytes | DHEAS only | Multiple analytes including<br>Triiodothyronine (Ta), Thyroxine<br>ff4), human Thyroid Stimulating<br>Hormone (TSH), and Cortisol |
| Storage | 2°C to 8°C | -10°C to -20°C |
| Stability | Unopened - until expiration date<br>on the vial label<br><br>Opened - 60 days | Unopened - until expiration date<br>on storage container when stored<br>as directed |
| Differences | Verification of calibration and<br>reportable range for the ADVIA<br>Centaur® DHEAS assay. | Verification of calibration,<br>linearity, and reportable range for<br>multiple assays (Triiodothyronine<br>(Ta), Thyroxine ff4), human<br>Thyroid Stimulating Hormone<br>(TSH), and Cortisol). |
| Matrix | Human Plasma | Human Serum |

## Comparison Table*

* From Instructions for Use

### Conclusions:

The ADVIA® Centaur DHEAS Master Curve Material is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Maine Standards Company, VALIDATE Thyroid Calibration Verification Test Set (K062501) in intended use, matrix, and stability.

Siemens Healthcare Diagnostics ADVIA Centaur DHEAS Master Curve Materials Premarket Notification - Abbreviated 510(k) 510(k) Summary

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an emblem that resembles a stylized caduceus, featuring a staff with a snake winding around it.

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

Siemens Healthcare Diagnostics c/o Clare Santulli 511 Benedict Avenue Tarrytown, NY 10591

# AUG 1 4 2009

k091123 Re:

Trade/Device Name: ADVIA Centaur DHEAS Master Curve Materials Regulation Number: 21 CFR § 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I (Reserved) Product Code: JJX Dated: June 11, 2009 Received: June 16, 2009

Dear Clare Santulli:

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 11 your as not 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 I toase of actived that I Drivination that your device complies with other requirements of the Act that + 21 there l 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 devicerelated 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.

G. C. H

Courtney C. Harper, Ph.D. Acting 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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# Indications for Use

510(k) Number (if known): K091123

ADVIA CENTAUR® DHEAS Master Curve Material Device Name(s):

Indications For Use:

The ADVIA® Centaur (DHEAS) Master Curve Material are for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA Centaur® Systems Dehydroepiandrosterone sulfate (DHEAS) assay.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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signature

Division Sign-Off

Office of in Vitro Diagnostic Device Evaluation and Safety

510(k) K091123