ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491

K103548 · Siemens Healthcare Diagnostics, Inc. · JIT · Jun 2, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103548
• Device Name: ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jun 2, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

For in vitro diagnostic use in calibrating the ADVIA Centaur® Total IgE (tIgE) quantitative assay on the ADVIA Centaur system.

Device Story

ADVIA Centaur Calibrator 80 is a 2-level lyophilized calibrator consisting of human IgE in equine serum with detergents and preservatives. Used in clinical laboratory settings to calibrate the ADVIA Centaur Total IgE assay. Healthcare professionals reconstitute the lyophilized material and load it onto the ADVIA Centaur analyzer. The system uses the calibrator values—entered via barcode scanner or keyboard—to establish a 2-point calibration curve for the tIgE assay. This calibration ensures the accuracy of patient sample measurements, facilitating clinical assessment of IgE levels.

Clinical Evidence

No clinical data. Performance characteristics, including traceability, value assignment, and stability, were validated via bench testing following Siemens Healthcare Diagnostics procedures.

Technological Characteristics

Lyophilized human IgE in equine serum with detergents and preservatives. 2-level kit. Reconstituted stability: 60 days at 2-8°C. On-board stability: 8 hours. Traceable to WHO standard 75/502. Used on ADVIA Centaur analyzer.

Indications for Use

Indicated for in vitro diagnostic use in calibrating the ADVIA Centaur Total IgE quantitative assay on the ADVIA Centaur system. Prescription use only.

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

• Siemens Healthcare Diagnostics (formerly Ciba Corning Diagnostics Corp.) ACS Calibrator B (k920372)

Submission Summary (Full Text)

{0}------------------------------------------------

## ADVIA Centaur® Calibrator 80

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.

#### k103548 A. 510(k) Number:

- B. Date of Preparation: May 11, 2011
- C. Proprietary and Established Names: ADVIA Centaur® Calibrator 80

#### D. Applicant

| Contact: | Sandra D. White, MS, RAC<br>Sr. Regulatory Technical Specialist |
|----------|-----------------------------------------------------------------------------------|
| Address: | Siemens Healthcare Diagnostics, Inc<br>333 Coney Street<br>East Walpole, MA 02032 |
| Phone: | [phone]<br>[phone] (fax) |

#### E. Regulatory Information:

- 1. Regulation section: 21 CFR §862.1150 Calibrator, Secondary
- 2. Classification: Class II
- 3. Product Code: JIT
-
- 4. Panel: 75 - Clinical Chemistry

## F. Predicate Device:

- 1. Device Name: Siemens Healthcare Diagnostics (formerly Ciba Corning Diagnostics Corp.) ACS Calibrator B
- 2. Common Name: Calibrator B
- 3. 510(k) Number: k920372
- 4. Manufacturer: Siemens Healthcare Diagnostics (formerly Ciba Corning Diagnostics Corp.)

#### G. Intended Use:

For in vitro diagnostic use in calibrating the ADVIA Centaur® Total IgE (tIgE) quantitative assay on the ADVIA Centaur system.

{1}------------------------------------------------

### H. Device Description:

"

The ADVIA Centaur® Calibrator 80 is a 2 level human IgE in equine serum containing detergents 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 Total IgE Calibrators have expected values of 35 and 1825 IU/mL.

The Calibrator 80 (2.0 mL/vial) is lyophilized. Storage for the lyophilized calibrators is at 2 - 8℃ until expiration date specified on label, the reconstituted calibrator storage is at 2 - 8ºC up to 60 days, and on board is up to 8 hours.

#### I. Substantial Equivalence Information:

1. Predicate device name: Siemens Healthcare Diagnostics (formerly Ciba Corning Diagnostics Corp.) Calibrator B

- 2. Predicate K number: k920372
- 3. Comparison with predicate:

| Similarities | | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | ADVIA Centaur® Calibrator 80<br>(New Device) | ADVIA Centaur® Calibrator B<br>(Predicate Device) |
| Number of Levéls | 2 | Same |
| Form | Lypholized | Same |
| Matrix | Equine serum | Same |
| Total IgE Target<br>Concentrations | Low Calibrator = 35 IU/mL<br>High Calibrator = 1825 IU/mL | Same |
| Storage Temperature | 2 - 8°C | Same |
| Differences | | |
| Item | ADVIA Centaur® Calibrator 80<br>(New Device) | ADVIA Centaur® Calibrator B<br>(Predicate Device) |
| Analytes | Single Analyte:<br>Total IgE (tIgE) | Multi Analyte:<br>Digoxin, FSH, Total IgE, LH LH2,<br>Prolactin, Total hCG, TSH |
| Ingredients | After reconstitution, low or high<br>levels of human IgE in equine<br>serum, detergents and<br>preservatives | After reconstitution, low or high<br>levels of the analytes listed in<br><i>Intended Use</i> in equine serum<br>with preservatives and protein<br>stabilizers |
| Stability | Unopened - until expiration date on the<br>vial label<br>Reconstituted - 60 days<br>On-board - 8 hours | Unopened - until expiration date on<br>the vial label<br>Reconstituted - 28 days<br>On-board - 4 hours |
| Fill Volume | 2 mL/vial | 5 mL/vial |

## J. Performance Characteristics:

The traceability, value assignment, and stability of the ADVIA Centaur® Calibrator 80 have been validated following procedures of Siemens Healthcare Diagnostics.

{2}------------------------------------------------

## K. Conclusion:

The ADVIA Centaur® Calibrator 80 is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Siemens Healthcare Diagnostics (formerly Ciba Corning Diagnostics Corp.) ACS Calibrator B (k920372).

-

:

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure with three human profiles forming its body and wings. The profiles are facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Siemens Healthcare Diagnostics, Inc. c/o Ms. Sandra D. White Manager Regulatory Affairs 333 Coney Street East Walpole, MA 02032

JUN 0 2 2011

Re: k103548

Trade/Device Name: ADVIA Centaur® Calibrator 80 Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: April 25, 2011 Reccived: April 28, 2011

Dear Ms. White:

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 class II (Special Controls), 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

{4}------------------------------------------------

Page 2 - Ms. Sandra D. white

requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation.(21 CFR Parts 801 and 809), 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Reena Philip

Kost Maria M. Chan, Ph.D. Director

Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

# Indication for Use

k103548 510(k) Number (if known):

Device Name: ADVIA Centaur® Calibrator 80

Indication for Use: .

For in vitro diagnostic use in calibrating the ADVIA Centaur® Total IgE (tIgE) quantitative assay on the ADVIA Centaur system.

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 (OIVD)

Reena Philip

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

510(k) k103548

Page 1 of