DIMENSION VISA ENZ 2 CAL

K103612 · Siemens Healthcare Diagnostics, Inc. · JIX · Jan 25, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103612
• Device Name: DIMENSION VISA ENZ 2 CAL
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jan 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The ENZ 2CAL is an in vitro diagnostic product for the calibration of the alanine aminotransferase (ALT and ALT )) and aspartate aminotransferase (AST) methods on the Dimension® Vista system.

Device Story

ENZ 2 CAL is a liquid, multi-analyte, bovine serum albumin-based calibrator containing porcine heart-derived alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Used in clinical laboratory settings to calibrate ALT and AST assays on the Dimension Vista System. The calibrator ensures the accuracy and traceability of patient sample measurements by establishing a reference point for the analyzer. It is intended for professional use by laboratory personnel. The device benefits patients by ensuring reliable, standardized diagnostic results for liver function testing.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Liquid, multi-analyte, bovine serum albumin-based calibrator. Contains porcine heart-derived ALT and AST. Traceable to Master pool and IFCC ALT primary reference method. Packaged in 1.5 mL glass vials. Stored at 2 to 8°C.

Indications for Use

Indicated for the calibration of ALT, ALTI, and AST assays on the Dimension Vista 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

• Dimension Vista® ENZ 2 CAL (KC320) (K061390)

Submission Summary (Full Text)

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# SIEMENS

JAN 2 5 2011

## 510(k) Summary for Dimension Vista ENZ 2 CAL KC321

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: K103612

## 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: December 1, 2010 ENZ 2 CAL (KC321) 2. Device Name: Classification: Class II (21CFR862.1150) JIX: Product Code: Panel: Clinical Chemistry (75) 3. ldentification of the Legally Marketed Device: Dimension Vista® ENZ 2 CAL (KC320) k061390

#### ব . Device Descriptions:

ENZ 2 CAL is a liquid, multi-analyte, bovine serum albumin based product containing alanine aminotransferase and aspartate aminotransferase from porcine heart.

### 5. Device Intended Uses:

### Dimension Vista® ENZ 2CAL (KC321)

The ENZ 2CAL is an in vitro diagnostic product for the calibration of the alanine aminotransferase (ALT and ALT )) and aspartate aminotransferase (AST) methods on the Dimension® Vista system.

Medical device to which equivalence is claimed and comparison information: 6. The Dimension Vista ENZ 2 CAL (KC321), is substantially equivalent to the Dimension Vistas

.

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## SIEMENS

ENZ 2 CAL (KC320). Like the predicate, ENZ 2 CAL is an in vitro diagnostic product intended to be used for the calibration of alanine aminotransferase, and aspartate aminotransferase assays.

### 7. Comparative Features Table

| Feature | Current | Modified |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Dimension Vista® ENZ 2<br>Calibrator KC320 | Dimension® Vista ENZ 2<br>Calibrator KC321 |
| Similarities | | |
| Form: | liquid, bovine serum albumin<br>based | liquid, bovine serum albumin<br>based |
| Constituents: | aspartate aminotransferase<br>and alanine aminotransferase<br>from porcine heart | aspartate aminotransferase<br>and alanine aminotransferase<br>from porcine heart |
| Traceability<br>of<br>constituents: | ALT and AST traceable to<br>Master pool, Dimension®<br>clinical chemistry system values | ALT and AST traceable to<br>Master pool, Dimension®<br>clinical chemistry system values |
| Packaging: | ENZ 2 CAL is packaged in<br>glass vials containing 1.5<br>mL/vial. Each carton contains 3<br>vials of each level. | ENZ 2 CAL, modified is<br>packaged in glass vials<br>containing 1.5 mL/vial. Each<br>carton contains 3 vials of each<br>level. |
| Levels: | 2 | 2 |
| Stability and<br>storage | ENZ 2 CAL is stored at 2 to 8°<br>C | ENZ 2 CAL is stored at 2 to 8°<br>C |
| Differences | | |
| Intended Use: | ENZ 2 CAL is an in vitro<br>diagnostic product for<br>calibration of the Aspartate<br>Aminotransferase (AST) and<br>Alanine Aminotransferase<br>(ALT) methods on the<br>Dimension Vista® System. | ENZ 2 CAL is an in vitro<br>diagnostic product for<br>calibration of the Aspartate<br>Aminotransferase (AST),<br>Alanine Aminotransferase (ALT<br>and ALTI) methods on the<br>Dimension Vista® System. |
| Traceability of<br>constituents: | | ALTI is traceable to the IFCC<br>ALT@ 37°C primary reference<br>method. |

#### 8. Conclusion

Dimension Vista® ENZ 2 CAL, KC321, is substantially equivalent in intended use to the legally marketed device, Dimension Vista® ENZ 2 CAL, KC320, based on the information described above.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.

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

Siemens Healthcare Diagnostics, Inc. c/o Ms. Anna Marie K. Ennis Senior Regulatory Affairs & Compliance Mgr. 500 GBC Drive, PO Box 6101 Newark, Delaware 19714-6101

> Re: k103612 Trade Name: Dimension Visa ENZ 2 CAL Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIX Dated: December 8, 2010 Received: December 9, 2010

JAN 2 5 201

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 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/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.

Courthey 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): _( ) 03612

Device Name: Dimension Vista® ENZ 2 CAL

Indications for Use:

The ENZ 2 CAL is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALT and ALTI) and Aspartate Aminotransferase (AST) on the Dimension Vista® System.

| Prescription Use_XX (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 OF NEEDED)

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

Signature

Division Sign-Off Office of In Vitro Diagnostic Device

Evaluation and Safety

K103612 510(k)_

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