MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL

K011662 · The Binding Site, Ltd. · DDG · Jul 30, 2001 · Immunology

Device Facts

• Record ID: K011662
• Device Name: MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL
• Applicant: The Binding Site, Ltd.
• Product Code: DDG · Immunology
• Decision Date: Jul 30, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5880
• Device Class: Class 2

Intended Use

This assay is designed for the in vitro measurement of human transferrin in serum using the Minineph®.

Device Story

Minineph® a-1 Transferrin Antiserum is an in vitro diagnostic reagent used for the quantitative measurement of human transferrin in serum. The device is intended for use with the Minineph® analyzer. It functions as an immunochemical assay where the antiserum reacts with transferrin in the patient serum sample to form an immune complex, which is then measured by the analyzer. The device is used in clinical laboratory settings by trained laboratory personnel. The output provides a quantitative concentration of transferrin, which assists clinicians in assessing iron metabolism and nutritional status. The device aids in the diagnosis and management of conditions related to transferrin levels.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Immunochemical reagent (antiserum) for use with the Minineph® analyzer. Operates via turbidimetric or nephelometric principles for protein quantification. Class II device, product code DDG (Regulation 866.5880).

Indications for Use

Indicated for the in vitro measurement of human transferrin in serum using the Minineph® system. For prescription use only.

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

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 3 0 2001

The Binding Site Limited c/o Mr. Jay H. Geller West Tower, Suite 4000 2425 West Olympic Boulevard Santa Monica, CA 90404

510(K) Number: K011662 Re: Trade/Device Name: Minineph® a-1 Transferrin Antiserum Regulation Number: 866.5880 Regulatory Class: II Product Code: DDG Dated: May 24, 2001 Received: May 29, 2001

Dear Mr. Geller:

We have reviewed your Section 510(k) notification of intent to market the device referenced w that to reveal your can in edevice is substantially equivalent (for the indications for use above and we nave active actively marketed predicate devices marketed in interstate commerce sured in the energed of the enactment date of the Medical Device Amendments, or to devices that provisions of the same with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 provisions of the Prod - 2004 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations ( Femanel 1 pp v ice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspotionist the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## KO11662

## INDICATIONS FOR USE STATEMENT

Minineph® a-1 Transferrin Antiserum Device Name:

This assay is designed for the in vitrophy as Indications for Use: Indications for Use . This assay is designical the Mininephy, as measurement of human transferrin in scrum doming the more of the

Division Sign-Off

(Division Sign-Off) (Division of Clinical Laboratory Devices KO1662 510(k) Number.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use v (Per 21 CFR 801.109) . OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Optional Formal 1-2-96