DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR

K081789 · Siemens Healthcare Diagnostics, Inc. · JIT · Sep 10, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081789
• Device Name: DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Sep 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The ENZ I CAL is an in vitro diagnostic product for the calibration of the LDI method on the Dimension® clinical chemistry system. For prescription use only

Device Story

ENZ I CAL is a liquid, bovine serum albumin-based calibrator containing lactate dehydrogenase (chicken heart). It is used to calibrate the LDI method on the Dimension® clinical chemistry system. The product is supplied in 4 vials (2 vials of Level 2, 2 vials of Level 3). Purified water or reagent grade water is required as the Level 1 calibrator. The device is used in clinical laboratory settings by trained personnel to ensure the accuracy of quantitative lactate dehydrogenase measurements. By establishing a calibration curve traceable to the IFCC reference method, the device enables the clinical chemistry system to provide accurate patient test results, supporting clinical decision-making regarding patient health status.

Clinical Evidence

No clinical data. Substantial equivalence is based on analytical traceability to the IFCC reference method for lactate dehydrogenase.

Technological Characteristics

Liquid, bovine serum albumin-based matrix containing lactate dehydrogenase (chicken heart). Ready-to-use form. Calibrator for clinical chemistry analyzer (Dimension®). Traceable to IFCC reference method. Storage at 2-8°C.

Indications for Use

Indicated for the calibration of the lactate dehydrogenase (LDI) method on the Dimension® clinical chemistry system for in vitro diagnostic use.

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

• Roche Calibrator for automated systems

Submission Summary (Full Text)

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# 510 (k) Summary for the Dimension® clinical chemistry system Enzyme I Calibrator (DC35)

| 510 (k) Number: | K081789 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyte: | Lactate dehydrogenase |
| Type of Test: | Calibrator Material |
| Applicant: | Siemens Healthcare Diagnostics Inc<br>P.O. Box 6101<br>Newark, DE 19714-6101<br>Helen M. Lee<br>Regulatory Affairs and Compliance Manager<br>Office Phone: [phone]<br>Fax: [phone] |

#### Proprietary and Established Name:

Dimension® clinical chemistry system Enzyme | Calibrator

## Regulatory Information:

Regulation Section: 21 CFR § 862.1150 - Calibrator Classification: Class II

Product Code: JIT - Calibrator, Secondary

Panel: Clinical Chemistry

#### Intended Use:

The ENZ I CAL is an in vitro diagnostic product for the calibration of the LDI method on the Dimension® clinical chemistry system.

#### Device Description:

ENZ I CAL is a liquid, bovine serum albumin based product containing lactate dehydrogenase (chicken heart). The calibrator packaging contains 4 vials, 2 vials of Level 2 and two vials of Level 3, with 1.5 mL per vial. Level 1 calibrator for LDI is not included in the ENZ I CAL carton. Purified Water Diluent (Cat. No. 710615901) or reagent grade water is required for use as Calibrator Level 1 for the LDI method.

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# Substantial Equivalence Information:

Comparison of the Dimension® clinical chemistry system Enzyme ! Calibrator, proposed device, to the predicate Roche Calibrator for automated systems.

| Item | New Device | Predicate Device |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyte | Lactate dehydrogenase. | Multi-analyte; including lactate<br>dehydrogenase. |
| Use | For the calibration of the lactate<br>dehydrogenase (LDI) method on the<br>Dimension® clinical chemistry system.<br>For <i>in vitro</i> diagnostic use. | For use in the calibration<br>of quantitative Roche methods on Roche<br>clinical chemistry analyzers<br>as specified in the value sheet.<br>For <i>in vitro</i> diagnostic use. |
| Matrix | Liquid bovine serum albumin base with<br>lactate dehydrogenase of chicken liver<br>origin. | Human serum base with lactate<br>dehydrogenase of porcine heart origin. |
| Form | Liquid | Lyophilized |
| Traceability | IFCC LD at 37 ° C primary reference<br>method. | Standardized against the original<br>formulation and procedures recommended<br>by the IFCC. |

## Comments on Substantial Equivalence:

Both the proposed ® clinical chemistry system Enzyme I Calibrator and the predicate Roche Calibrator for automated systems are traceable to IFCC reference method and used to calibrate IFCC traceable lactate dehydrogenase methods.

## Conclusion:

The Dimension® Enzyme | Calibrator is substantially equivalent to the Roche Calibrator for automated systems based upon the information above.

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Image /page/2/Picture/1 description: The image contains the seal of the Department of Health & Human Services, USA. The seal features an eagle-like emblem with three stylized, curved lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Siemens Healthcare Diagnostics Inc. c/o Ms. Helen M. Lee 500 GBC Drive P.O. Box 6101, Mailbox 514 Newark, DE 19714-6101

SEP 1 0 2008

k081789 Rc:

> Trade/Device Name: Dimension® Chemistry System Enzyme I Calibrator (ENZ I Cal) Regulation Number: 21 CFR§ 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: June 24, 2008 Received: June 25, 2008

Dear Ms. Lee:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yéan M. Cooper, M.S., D.V.M. 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 Statement

#### Kori759 510(k) Number (if known):

Device Name:

Dimension® clinical chemistry system Enzyme I Calibrator (ENZ I CAL)

#### Indications for Use:

The ENZ I CAL is an in vitro diagnostic product for the calibration of LDI method on the Dimension® clinical chemistry system.

Prescription Use (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)

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

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

Carol C Benson
Division Sign-Off

**vision Sign-Off**

Office of In Vitro Diagnostic De lation and Safe

K081789