TRANSFERRIN KIT FOR USE ON THE SPAPLUS

K120236 · The Binding Site Group , Ltd. · DDG · Feb 13, 2013 · Immunology

Device Facts

• Record ID: K120236
• Device Name: TRANSFERRIN KIT FOR USE ON THE SPAPLUS
• Applicant: The Binding Site Group , Ltd.
• Product Code: DDG · Immunology
• Decision Date: Feb 13, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5880
• Device Class: Class 2

Intended Use

The Binding Site Human Transferrin Kit is intended for the quantitative determination of human transferrin using the Binding Site SPAPlus™ turbidimetric analyzer in human serum. The measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection and iron deficiency anemia. This test should be used in conjunction with other laboratory and clinical findings.

Device Story

The Human Transferrin Kit is an in vitro diagnostic assay for use on the SPAPlus™ turbidimetric analyzer. It utilizes sheep anti-human transferrin antiserum to react with transferrin in human serum, forming insoluble complexes. The analyzer passes light through the sample; an optical lens system focuses transmitted light onto a photodiode. The amount of transmitted light is inversely proportional to the transferrin concentration. The instrument automatically calculates concentrations using a calibration curve. The device is intended for use in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing iron deficiency anemia, malnutrition, and inflammatory conditions. The kit includes antiserum, calibrators, controls, and reaction buffer.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and performance characteristics of the assay on the SPAPlus analyzer.

Technological Characteristics

Turbidimetric immunoassay for the quantitative determination of human transferrin. Designed for use on the SPAPlus automated analyzer. Analyzes human serum samples.

Indications for Use

Indicated for the quantitative determination of human transferrin in human serum to aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia. For use by clinical laboratory professionals.

Regulatory Classification

Identification

A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

The Binding Site Group, Ltd. c/o Dr. Jill Constantine. Regulatory Affairs Scientist 8 Calthorpe Road Edgbaston, Birmingham West Midlands UK B15 IQT

February 13, 2013

· Re: k120236

Trade/Device Name: Human Transferrin kit for use on the SPAPlus™ Regulation Number: 21 CFR §866.5880 Regulation Name: Transferrin Immunological Test System Regulatory Class: Class II Product Code: DDG Dated: February 11, 2013 Received: February 11, 2013

Dear Dr. Constantine:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical

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Page 2 - Dr. Jill Constantine

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

## Maria Mi &han -S

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): k120236

Human Transferrin Kit for use on SPAPLus Device Name:

Indications For Use:

The Binding Site Human Transferrin Kit is intended for the quantitative determination of human transferrin using the Binding Site SPAPLus turbidimetric analyzer in human serum. The measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection and iron deficiency anemia. This test should be used in conjunction with other laboratory and clinical findings

Prescription Use

· AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

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Office of In Vitro Diagnostics and Radiological Health

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