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.

Device Description

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

AI/ML Overview

The provided text describes a 510(k) summary for an "Anemia Calibrator" device. However, it does not contain any information about acceptance criteria, device performance results from a study, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document focuses on:

Manufacturer and device identification: Siemens Healthcare Diagnostics, Anemia Calibrator, Class II device.
Intended Use: Calibration of Ferritin (FERR), LOCI Vitamin B12 (B12), and LOCI Folate (FOL) methods on the Dimension® EXL™ integrated chemistry system and Dimension® clinical chemistry system.
Substantial Equivalence: Comparison to a predicate device (Dimension Vista® LOCI 4 Calibrator), highlighting similarities (intended use, form, constituents, traceability, levels, stability) and differences (system compatibility).
FDA Clearance Letter: Official notification of substantial equivalence determination.

Therefore, I cannot provide the requested information. The input document simply does not contain the details necessary to answer those points.

Summary

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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: 302-631-9352

Fax: 302-631-6299

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 DeviceDimension Vista® LOCI 4 Calibrator	New DeviceDimension® Anemia Calibrator
Similarities
Intended Use:	LOCI 4 CAL is an in vitro diagnosticproduct for calibration of the Ferritin(FERR), Vitamin B12 (B12) and Folate(FOL) methods on the Dimension Vista®System.	ANEMIA CAL is an in vitrodiagnostic product for calibration ofthe Vitamin B12 (B12) and Folate(FOL) methods on the Dimension®EXLTM integrated chemistry systemand the Ferritin (FERR) method onthe Dimension® clinical chemistrysystem.
Form:	frozen liquid, bovine serum albumin	frozen liquid, bovine serum albumin
Constituents:	ferritin from human liver, vitamin B12and folate	ferritin from human liver, vitaminB12 and folate
Traceability ofconstituents:	ferritin - human serum based anchorpool containing WHO Standard forFerritin, 3rd IS 94/572	ferritin - human serum based anchorpool containing WHO Standard forFerritin, 3rd IS 94/572
	vitamin B12 - Human serum basedanchor pool containing USP gradeVitamin B12	vitamin B12 - Human serum basedanchor pool containing USP gradeVitamin B12
	folate - human serum based anchor poolcontaining USP grade folic acid	folate - human serum based anchorpool 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 -15 °C
	LOCI 4 CAL is stable, thawed andunopened for 30 days @ 2 - 8 °C	ANEMIA CAL is stable, thawed andunopened for 30 days @ 2 - 8 °C
Differences	LOCI 4 Cal is for use on the DimensionVista® System.	ANEMIA CAL is for use on theDimension® EXLTM integratedchemistry 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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Page 2

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 (301) 796-5450. 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 (301) 796-5760. 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 (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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:

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

Page 1 of

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
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.)(b)
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.