EXL ANEM CAL, MODEL RC640

K093645 · Siemens Healthcare Diagnostics · JIX · Mar 5, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093645
• Device Name: EXL ANEM CAL, MODEL RC640
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JIX · Clinical Chemistry
• Decision Date: Mar 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The ANEMIA CAL is an in vitro diagnostic product for the calibration of the LOCI Vitamin B12 (B12) and LOCI Folate (FOL) methods on the Dimension® EXL™ integrated chemistry system and the Ferritin (FERR) method on the Dimension® clinical chemistry system.

Device Story

Dimension EXL Anemia Calibrator is a multi-analyte, liquid, frozen, bovine serum albumin-based product; contains human liver-derived ferritin, Vitamin B12, and Folate. Used in clinical laboratory settings to calibrate Vitamin B12, Folate, and Ferritin assays on Dimension EXL integrated chemistry systems. Calibrator kit includes ten vials across five levels. Healthcare professionals use the calibrator to establish assay traceability and ensure accurate patient sample measurement. Human source materials are tested for HbsAg, anti-HCV, and HIV-1/2.

Clinical Evidence

No clinical data. Bench testing only. Stability and value assignment protocols were validated; traceability established using USP grade materials and WHO IS 94/572 standards.

Technological Characteristics

Multi-analyte, liquid, frozen, bovine serum albumin-based matrix. Contains human liver-derived ferritin, USP grade Vitamin B12, and Folate. Five-level kit configuration. Storage: -25 to -15°C (unopened); 30-day stability at 2-8°C (thawed/unopened).

Indications for Use

Indicated for the calibration of Ferritin, Vitamin B12, and Folate assays on Dimension EXL integrated chemistry systems and Dimension clinical chemistry systems.

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® LOCI 4 Calibrator (k071224)

Submission Summary (Full Text)

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## 510(k) Summary for Anemia Calibrator

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: (0936465

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

Siemens Healthcare Diagnostics, Inc. Manufacturer:

500 GBC Drive

Newark, DE 19714

Siemens Healthcare Diagnostics, Inc. Contact Information:

500 GBC Drive

Newark, DE 19714

Attn: A. Kathleen Ennis

Tel: [phone]

Fax: [phone]

November 23, 2009 Preparation date:

- Anemia Calibrator 2. Device Name:
Classification: Class II

Product Code: JIX;

Clinical Chemistry (75) Panel:

## Identification of the Legally Marketed Device: 3.

Dimension Vista ® LOCI 4 Calibrator k071224

#### Device Descriptions: 4.

ANEMIA CAL is a multi-analyte, liquid, frozen bovine serum albumin based product containing ferritin from human liver, Vitamin B12 and Folate

MAR - 5 2010

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#### Device Intended Uses: 5.

## Dimension Anemia Calibrator

The ANEMIA CAL is an in vitro diagnostic product for the calibration of Ferritin (FERR), LOCI Vitamin B12 (B12) and LOCI Folate (FOL) methods on the Dimension ® EXL™ integrated chemistry system.

- Medical device to which equivalence is claimed and comparison information: 6. The ANEMIA CAL is substantially equivalent to the Dimension Vista® LOCI 4 Calibrator. ANEMIA CAL, like the predicate, is an in vitro diagnostic product intended to be used for the calibration of Ferritin, Vitamin B12 and Folate assays.

| Feature | Predicate Device<br>Dimension Vista® LOCI 4 Calibrator | New Device<br>Dimension® Anemia Calibrator |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use: | LOCI 4 CAL is an <i>in vitro</i> diagnostic<br>product for calibration of the Ferritin<br>(FERR), Vitamin B12 (B12) and Folate<br>(FOL) methods on the Dimension Vista®<br>System. | ANEMIA CAL is an <i>in vitro</i><br>diagnostic product for calibration of<br>the Vitamin B12 (B12) and Folate<br>(FOL) methods on the Dimension®<br>EXLTM integrated chemistry system<br>and the Ferritin (FERR) method on<br>the Dimension® clinical chemistry<br>system. |
| Form: | frozen liquid, bovine serum albumin | frozen liquid, bovine serum albumin |
| Constituents: | ferritin from human liver, vitamin B12<br>and folate | ferritin from human liver, vitamin<br>B12 and folate |
| Traceability of<br>constituents: | ferritin - human serum based anchor<br>pool containing WHO Standard for<br>Ferritin, 3rd IS 94/572 | ferritin - human serum based anchor<br>pool containing WHO Standard for<br>Ferritin, 3rd IS 94/572 |
| | vitamin B12 - Human serum based<br>anchor pool containing USP grade<br>Vitamin B12 | vitamin B12 - Human serum based<br>anchor pool containing USP grade<br>Vitamin B12 |
| | folate - human serum based anchor pool<br>containing USP grade folic acid | folate - human serum based anchor<br>pool containing USP grade folic acid |
| Levels: | 5 | 5 |
| Stability and storage | LOCI 4 CAL is stored at -20 to -10 °C | ANEMIA CAL is stored at -25 to -<br>15 °C |
| | LOCI 4 CAL is stable, thawed and<br>unopened for 30 days @ 2 - 8 °C | ANEMIA CAL is stable, thawed and<br>unopened for 30 days @ 2 - 8 °C |
| Differences | LOCI 4 Cal is for use on the Dimension<br>Vista® System. | ANEMIA CAL is for use on the<br>Dimension® EXLTM integrated<br>chemistry system. |

#### Comparative Features Table 7.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three wing segments, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Siemens Healthcare Diagnostics c/o Anna M. Kathleen Ennis 500 GBC Drive M/S 514 PO Box 6101 Newark, Delaware 19714

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

Har 0 5 2010

Re: k093645

> Trade Name: Anemia Calibrator Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator. Regulatory Class: Class II Product Codes: JIX Dated: January 20, 2010 Received: January 21, 2010

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 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 Form

510(k) Number (if known): ko 93 64 5

Anemia Calibrator Device Name:

Indications for Use:

ANEMIA CAL is an in vitro diagnostic product for the calibration of the LOCI Vitamin B12 (B12)and LOCI Folate(FOL) methods on the Dimension(r) EXI(tm) integrated chemistry system and the Ferritin(FERR) method on the Dimension(r) clinical chemistry system.

XXXXX Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (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)

Carol Benson

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

510(k) K093645

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