DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H

K110169 · Siemens Healthcare Diagnostics · JIT · Apr 7, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110169
• Device Name: DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JIT · Clinical Chemistry
• Decision Date: Apr 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

Dimension Vista® CDT CAL CDT CAL is an in vitro diagnostic product for the calibration of the carbohydrate-deficient transferring (CDT) method on the Dimension Vista® System. Dimension Vista® CDT CON L CDT CON L is an assayed, low level, intra-laboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of carbohydrate-deficient transferrin (CDT) Dimension Vista® CDT CON H CDT CON H is an assayed, high level, intra-laboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of carbohydrate-deficient transferring (CDT).

Device Story

Dimension Vista® CDT CAL, CON L, and CON H are liquid, human serum-based products containing carbohydrate-deficient transferrin. Used as calibrators and assayed quality controls for the Dimension Vista® System. Laboratory personnel use these products to calibrate the CDT assay and monitor analytical precision and bias. The output provides reference values for system calibration and performance verification, ensuring accurate quantitative measurement of CDT in patient samples. These products support clinical decision-making by maintaining the accuracy of diagnostic testing for CDT, a biomarker often associated with chronic alcohol consumption.

Clinical Evidence

No clinical data. Bench testing only. Stability was validated via real-time studies confirming performance until expiration when stored at 2-8°C and 14-day open-vial stability on the system. Traceability established against an internally produced master calibrator calibrated against a highly purified in-house protein preparation. Value assignment performed via quadruplicate analysis across multiple runs on the Dimension Vista 1500 analyzer.

Technological Characteristics

Liquid human serum-based products. Calibrator and assayed quality control materials. Storage at 2-8 °C. Shelf life of 24 months. Designed for use on the Dimension Vista® System. No specific materials of construction or software algorithms described.

Indications for Use

Indicated for use as an in vitro diagnostic calibrator and assayed quality control material for the quantitative determination of carbohydrate-deficient transferrin (CDT) on the Dimension Vista® 1500 System. Intended for professional laboratory 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

• Siemens N Latex CDT Test Kit (K060677)

Submission Summary (Full Text)

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2011 - /

# 510(k) Summary for Dimension Vista® CDT CAL Dimension Vista® CDT CON L and H

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:

er is: K116169

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

| Manufacturer: | Siemens Healthcare Diagnostics Products GmbH<br>Emil von Behring Str. 76<br>Marburg, 35041 Germany |
|---------------|----------------------------------------------------------------------------------------------------|
|---------------|----------------------------------------------------------------------------------------------------|

Siemens Healthcare Diagnostics Contact Information: P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: [phone] Fax: [phone]

March 30, 2011 Preparation date:

#### 2. Device Name:

Dimension Vista® CDT CAL Dimension Vista® CDT CON L and H

Classification:

Calibrator, Secondary, Class II Single-Analyte Controls, Class I

JIT: JJX Product Code: Chemistry Panel:

- ldentification of the Legally Marketed Device: 3.
Siemens N Latex CDT Test Kit

### Device Description: 4.

### Dimension Vista® CDT CAL

CDT CAL is a liquid human serum based product containing carbohydrate-deficient transferrin.

### Dimension Vista® CDT CON L

CDT CON L is a low level, liguid human serum based product containing human carbohydratedeficient transferrin.

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# Dimension Vista® CDT CON H

CDT CON H is a high level, liquid human serum based product containing human carbohydratedeficient transferrin.

#### 5. Device Intended Use:

## Dimension Vista® CDT CAL

CDT CAL is an in vitro diagnostic product for the calibration of the carbohydrate-deficient transferrin (CDT) method on the Dimension Vista® System.

## Dimension Vista® CDT CON L

CDT CON L is an assayed, low level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of carbohydrate-deficient transferrin (CDT).

### Dimension Vista® CDT CON H

CDT CON H is an assaved, high level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of carbohydrate-deficient transferrin (CDT).

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

The Dimension Vista® CDT CAL and CON L and CON H are substantially equivalent to the Siemens N Latex CDT Test Kit (k060677), which contains N CDT Standard, N CDT Control 1 and N CDT Control 2 respectively.

| Item | Device (k110169)<br>Dimension Vista® CDT CAL | Predicate<br>N CDT Standard |
|--------------|----------------------------------------------------------------------------------------------------|-----------------------------|
| Contents | 4 vials, (4A, 2.0 mL per vial) | 3 X 1mL |
| Storage Temp | 2 - 8 °C. | Same |
| Shelf life | 24 months | Same |
| Composition | CDT CAL is a liquid human serum<br>based product containing<br>carbohydrate-deficient transferrin. | Same |

## Similarities and Differences

### Similarities and Differences

| ltem | Device (k110169)<br>Dimension Vista® CDT<br>CON L and H | Predicate<br>N CDT Con L<br>and H |
|--------------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Contents | 4 vials, (4Low and 4 High, 2.0 mL<br>per vial) | 3 X 1mL |
| Storage Temp | 2 - 8 °C. | Same |
| Shelf life | 24 months | Same |
| Composition | CDT CON L and H are liquid<br>human serum based products<br>containing human carbohydrate-<br>deficient transferrin. | Same |

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.

Siemens Healthcare Diagnostics c/o Kathleen Dray-Lyons

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

Image /page/2/Picture/5 description: The image shows the date "APR 7 2011" in a bold, sans-serif font. The letters and numbers are closely spaced, giving the date a compact appearance. The text is likely part of a document or label where the date is relevant.

Re: k110169

500 GBC Drive

Newark, Delaware 19714

PO Box 6101

Trade Name: Dimension Vista CDT Calibrator Dimension Vista CDT Control L, Dimension Vista CDT Control H Regulation Number: 21 CFR§862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIT, JJX Dated: January 19, 2011 Received: January 20, 2011

Dear Ms. Dray-Lyons:

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 paremarket 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 the [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

G.C.

Courmey 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): | ||0169

Device Name: Dimension Vista® CDT CAL Dimension Vista® CDT CON L Dimension Vista®CDT CON H

Indications For Use:

# Dimension Vista® CDT CAL

CDT CAL is an in vitro diagnostic product for the calibration of the carbohydrate-deficient transferrin (CDT) method on the Dimension Vista® System.

# Dimension Vista® CDT CON L

CDT CON L is an assayed, low level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of carbohydrate-deficient transferrin (CDT).

# Dimension Vista® CDT CON H

CDT CON H is an assayed, high level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of carbohydrate-deficient transferrin (CDT).

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

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

AND/OR

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

Carol C. Benson

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