ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770

K093732 · Siemens Healthcare Diagnostics · JIX · Mar 22, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093732
• Device Name: ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JIX · Clinical Chemistry
• Decision Date: Mar 22, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The ADVIA® Chemistry DRUG Calibrator I is for in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and Theophylline_2 (THEO_2) methods on the ADVIA Chemistry Systems. For prescription use.

Device Story

Liquid, human serum-based calibrator; ready-to-use. Contains Phenobarbital, Phenytoin, and Theophylline at defined concentrations. Used in clinical laboratory settings to calibrate ADVIA Chemistry Systems. Value assignment achieved via alignment with master lots of previously cleared calibrators and confirmation through method comparisons using patient samples. Provides reference points for clinical chemistry analyzers to ensure accurate patient sample measurement. Handled by laboratory personnel as potentially infectious human-source material.

Clinical Evidence

No clinical data provided; bench testing only. Equivalence established through comparison of formulation, matrix, stability, and traceability to USP standards.

Technological Characteristics

Multi-analyte liquid calibrator; human serum matrix; 5 levels; 3.0 mL per vial. Traceable to USP standards. Shelf-life 18 months; 90-day open-vial stability. No software or electronic components.

Indications for Use

Indicated for in vitro diagnostic calibration of Phenobarbital, Phenytoin, and Theophylline methods on ADVIA Chemistry Systems. No specific patient population, age, or gender restrictions provided.

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

• Dade Behring Dimension Drug Calibrator (k011035)

Submission Summary (Full Text)

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#### 510(k) Summary of Safety and Effectiveness for the

#### ADVIA® Chemistry DRUG Calibrator I

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: K093732

B. Date of Preparation: December 03, 2009

#### C. Proprietary and Established Names:

MAR 2 2 2010

ADVIA® Chemistry DRUG Calibrator I

#### D. Applicant:

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

Kira Gordon, Sr. Regulatory Affairs Specialist

Office: [phone] Fax: [phone]

### E. Regulatory Information:

ADVIA Chemistry DRUG Calibrator I

- 1. Regulation section: 21 CFR § 862.1150 Calibrator.
- 2. Classification: Class II
- 3. Product Code: JIX, calibrator, multi-analyte mixture
- 4. Panel: Clinical Chemistry

#### F. Predicate Device:

ADVIA Chemistry DRUG Calibrator I is substantially equivalent to the (formerly) Dade Behring Dimension Drug Calibrator (DC22B) cleared under K011035.

#### G. Device Description:

ADVIA Chemistry DRUG Calibrator I is a multi-analyte, liquid, human serum based product containing multiple analytes. The kit consists of 2 vials each of 5 calibrator levels which are ready for use (no preparation is required). The volume per vial is 3.0 mL. Phenobarbital, Phenytoin, and Theophylline are value assigned for ADVIA

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Chemistry systems. In addition DRUG Calibrator I also contains Lithium and Digoxin with no specific value assignment on ADVIA Chemistry systems at this time.

## H. Intended Use:

The ADVIA Chemistry DRUG Calibrator I is for in vitro diagnostic use in the calibration of Phenobarbital (PHNB_2), Phenytoin (PHNY_2), and Theophylline (THEO 2) methods on the ADVIA Chemistry Systems

# I. Substantial Equivalence Information:

The ADVIA Chemistry DRUG Calibrator I and Dimension Drug Calibrator I were compared in the following table.

| Item | New Device - The ADVIA<br>Chemistry DRUG Calibrator I | Predicate Device - (formerly) Dade<br>Behring Dimension Drug Calibrator<br>(DC22B) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | for in vitro diagnostic use in the<br>calibration of Phenobarbital_2<br>(PHNB_2), Phenytoin_2 (PHNY_2),<br>and Theophylline_2 (THEO_2)<br>methods on the ADVIA Chemistry<br>Systems . | DRUG CAL is an in vitro diagnostic<br>product intended to be used to calibrate<br>digoxin, lithium, phenobarbital,<br>phenytoin and theophylline methods on<br>the Dimension System |
| Formulation /<br>analytes present | Digoxin<br>Phenobarbital<br>Phenytoin<br>Theophylline<br>Lithium | Digoxin<br>Phenobarbital<br>Phenytoin<br>Theophylline<br>Lithium |
| Measured<br>Analytes (value<br>assigned) | Phenobarbital<br>Phenytoin<br>Theophylline | Digoxin<br>Phenobarbital<br>Phenytoin<br>Theophylline<br>Lithium |
| Form | Liquid | Liquid |
| Traceability | USP | USP |
| Matrix | Human Serum | Human Serum |
| Number of<br>Levels | five | five |
| Packaging | Ten vials: two vials at five levels (3.0<br>mL each) | Ten vials: two vials at five levels (3.0<br>mL each) |
| Stability | 18 months - shelf-life<br>90 days open vial | 18 months - shelf-life<br>90 days open vial |

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## J. Conclusion:

The multi-analyte, five level, human serum based ADVIA Chemistry DRUG Calibrator I is substantially equivalent to the Dimension DRUG Calibrator. They are identical in composition and both used in calibration of TDM methods on Chemistry systems.

・

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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 a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is stylized and simplified, with only a few lines used to create its form.

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

Siemens Healthcare Diagnostics c/o Kira Gordon 511 Benedict Ave Tarrytown, NY 10591

k093732 Re:

Trade Name: Advia Chemistry Drug Calibrator I Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIX Dated: February 5, 2010 Received: February 12, 2010

MAR 2 2 2010

Dear Ms. Gordon:

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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## Indications for Use

K093732 510(k) Number (if known):

Device Name: ADVIA® Chemistry DRUG Calibrator I

Indications For Use:

For in vitro diagnostic use in the calibration of Phenobarbital 2 (PHNB 2), Phenytoin 2 (PHNY_2), and Theophylline_2 (THEO_2) methods on the ADVIA Chemistry Systems .

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)

Carol C. Benson

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

K 093732

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