(62 days)
This assay is designed for the in vitro measurement of human transferrin in serum using the Minineph®.
Not Found
I am sorry, but the provided text from the FDA 510(k) notification for "Minineph® a-1 Transferrin Antiserum" does not contain information regarding:
- Acceptance criteria and device performance table
- Sample size and data provenance for a test set
- Number of experts and their qualifications for ground truth establishment
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
This document is primarily a clearance letter confirming substantial equivalence to a predicate device and outlining the indications for use. It does not delve into the detailed study design, performance data, or ground truth methodologies that would typically be found in a more comprehensive clinical or analytical validation report.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged in a circular pattern around the eagle.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
§ 866.5880 Transferrin immunological test system.
(a)
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.(b)
Classification. Class II (performance standards).