ENZYME II CALIBRATOR

K103836 · Siemens Healthcare Diagnostics, Inc. · JIT · Feb 16, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103836
• Device Name: ENZYME II CALIBRATOR
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Feb 16, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Enzyme II Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI) on the Dimension® clinical chemistry system.

Device Story

ENZ II CAL is a liquid, bovine serum albumin-based calibrator containing alanine aminotransferase derived from porcine heart. It is designed for use with the Dimension® clinical chemistry system to calibrate the alanine aminotransferase (ALTI) assay. The product is supplied in plastic vials (1.5 mL/vial) across three levels (0 U/L, 550 U/L, and 1100 U/L). It is intended for professional use in clinical laboratory settings. By providing known concentrations of the analyte, the calibrator allows the clinical chemistry system to establish a calibration curve, ensuring the accuracy and reliability of patient sample measurements. This process supports healthcare providers in diagnosing and monitoring liver function and other clinical conditions associated with ALT levels.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Liquid, bovine serum albumin-based calibrator. Contains alanine aminotransferase from porcine heart. Three-level configuration (0, 550, 1100 U/L). Traceable to IFCC ALT @ 37°C primary reference method. Stored at 2 to 8 °C. Packaged in 1.5 mL plastic vials.

Indications for Use

Indicated for the calibration of the Alanine Aminotransferase (ALTI) assay on the Dimension® clinical chemistry system. For professional 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

• Dimension Vista® ENZ 2 CAL (k061390)

Submission Summary (Full Text)

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## SIEMENS

### 510(k) Summary for Dimension ® ENZ II CAL

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.

The assigned 510(k) number is: _ K |03836

- 1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:

| Manufacturer: | Siemens Healthcare Diagnostics, Inc. |
|---------------|--------------------------------------|
| | 500 GBC Drive |
| | Newark, DE 19714 |

- Contact Information: Siemens Healthcare Diagnostics, Inc. 500 GBC Drive Newark, DE 19714 Attn: A. Kathleen Ennis Tel: [phone] Fax: [phone]
Preparation date: November 15, 2010

- 2. Device Name: ENZ II CAL
Classification: Class II

Product Code: JIX;

Panel: Clinical Chemistry (75)

- 3. Identification of the Legally Marketed Device:
Dimension Vista® ENZ 2 CAL k061390

#### 4. Device Descriptions:

ENZ II CAL is a liquid, multi-analyte, bovine serum albumin based product containing alanine aminotransferase from porcine heart.

#### 5. Device Intended Uses:

Dimension Vista ® ENZ 2CAL

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## SIEMENS

The ENZ II CAL is an in vitro diagnostic product for the calibration of the alanine aminotransferase (ALT I) method on the Dimension® clinical chemistry system.

### 6. Medical device to which equivalence is claimed and comparison information:

The Dimension® ENZ II CAL, modified, is substantially equivalent to the Dimension Vista® ENZ 2 CAL. ENZ II CAL like the predicate, is an in vitro diagnostic product intended to be used for the calibration of the alanine aminotransferase assay.

#### 7. Comparative Features Table

| Feature | Predicate Device<br>Dimension Vista® ENZ 2 Calibrator | New Device<br>Dimension® ENZ II Calibrator |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use: | ENZ 2 CAL is an <i>in vitro</i> diagnostic<br>product for calibration of automated<br>clinical chemistry analyzers. | ENZ II CAL is an <i>in vitro</i><br>diagnostic product for calibration<br>of automated clinical chemistry<br>analyzers |
| Form: | liquid, bovine serum albumin based | liquid, bovine serum albumin<br>based |
| Packaging: | ENZ 2 CAL is packaged in plastic<br>vials containing 1.5 mL/vial. Each<br>carton contains 2 vials of each level. | ENZ II CAL is packaged in plastic<br>vials containing 1.5 mL/vial. Each<br>carton contains 2 vials of each<br>level. |
| Stability and<br>storage | ENZ 2 CAL is stored at 2 to 8 °C | ENZ II CAL is stored at 2 to 8 °C |
| Differences | | |
| Intended Use: | ENZ 2 CAL is an <i>in vitro</i> diagnostic<br>product for calibration of the<br>Aspartate Aminotransferase (AST)<br>and Alanine Aminotransferase (ALT)<br>methods on the Dimension Vista®<br>System. | ENZ II CAL is an <i>in vitro</i><br>diagnostic product for calibration<br>of the Alanine Aminotransferase<br>(ALTI) method on the Dimension<br>® clinical chemistry system. |
| Assigned<br>Constituents: | aspartate aminotransferase and<br>alanine aminotransferase from<br>porcine heart | alanine aminotransferase from<br>porcine heart |
| Traceability of<br>constituents: | ALT and AST traceable to Master<br>pool, Dimension® clinical chemistry<br>system values | ALT I traceable to the IFCC<br><br>ALT @ 37°C primary reference<br>method. |
| Levels: | 2 levels<br>Level 1 - 0 U/L<br>Level 2 - 1047 U/L | 3 levels<br>Level 1 - 0 U/L<br>Level 2 - 550 U/L<br>Level 3 - 1100 U/L |

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# SIEMENS

#### 8. Conclusion

Dimension ENZ II CAL is substantially equivalent in intended use to the legally marketed device, Dimension Vista® ENZ 2 Calibrator based on the information described above.

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Public Health Service

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

FEB 1 6 2011

Siemens Healthcare Diagnostics, Inc. c/o Anna Marie Kathleen Ennis. Regulatory Affairs Manager 500 GBC Drive PO Box 6101 Newark, DE 19714-6101, USA

Re: k103836

Trade Name: Siemens Dimension® ENZ II Calibrator Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrators Regulatory Class: Class II Product Codes: JIT Dated: February 9, 2011 Received: February 10, 2011

Dear Ms. Ennis:

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 Parts 801 and 809), please contact the Office of In Viro 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/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 [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

C.C.

Courtney 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 Form

510(k) Number (if known): K1038360 Device Name: Dimension® ENZ II CAL Indications for Use:

The Enzyme II Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI) on the Dimension® clinical chemistry system.

| Prescription Use _XX_<br>(Part 21<br>CFR 801 Subpart D) | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |
|---------------------------------------------------------|--------|------------------------------------------------|
|---------------------------------------------------------|--------|------------------------------------------------|

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

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

District Court Officer

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) 12/0383

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