(135 days)
No
The device description details a standard immunonephelometry method based on light scattering and comparison to a standard, with no mention of AI or ML terms or concepts.
No
The device is an in vitro diagnostic reagent used to measure transferrin levels, which aids in diagnosis. It does not directly treat or prevent a disease, injury, or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device aids in the diagnosis of various medical conditions, such as malnutrition, acute inflammation, infection, and iron deficiency anemia, which is a characteristic function of a diagnostic device.
No
The device description clearly describes a method involving immunochemical reactions and light scattering, which are physical processes requiring hardware components (reagents, light source, detector) for measurement. It is an in vitro diagnostic reagent kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "In vitro diagnostic reagents for the quantitative determination of transferrin in human serum, heparinized and EDTA plasma, as well as transferrin in human urine". This clearly indicates the device is intended for use on samples taken from the human body (in vitro) to diagnose or aid in the diagnosis of medical conditions.
- Device Description: The description details a method for analyzing components of human body fluids (proteins) using an immunochemical reaction. This is a common characteristic of IVD devices.
- Measurement of transferrin levels aids in the diagnosis: The intended use also states that the measurement "aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders". This further confirms its diagnostic purpose.
N/A
Intended Use / Indications for Use
In vitro diagnostic reagents for the quantitative determination of transferrin in human serum, heparinized and EDTA plasma, as well as transferrin in human urine by means of immunonephelometery on the BN™ Systems. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
Product codes
DDG
Device Description
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
To demonstrate equivalence in measurement between serum and heparinized or EDTA plasma, method comparisons were performed. The studies demonstrate equivalent performance with correlation coefficients between 0.96 and 0.98
Key Metrics
correlation coefficients between 0.96 and 0.98
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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510(k) Summary for N Antisera to Human Transferrin
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.
Image /page/0/Picture/4 description: The image shows the text "The assigned 510(k) number is:" followed by the number K053075. The number is written in a handwritten style, and there is an underline beneath it. The text is likely part of a document or form related to medical device approval.
1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
Manufacturer:
Dade Behring Marburg GmbH Emil-von-Behring Str. 76 D-35001 Marburg, Germany
Contact Information:
Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497
Preparation date:
February 17, 2006
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- Device Name/ Classification: N Antisera to Human Transferrin Class: Transferrin Immunological Test System, Class II, 21 CFR 866.5880 Panel: Immunology Product Code: DDG
3. Identification of the Legally Marketed Device:
N Antisera to Human Transferrin– K972840
4. Device Description:
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
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5. Device Intended Use:
In vitro diagnostic reagents for the quantitative determination of transferrin in human m viro diagnostic reagents for the qualifical as transferrin in human urine by means of immunonephelometry on the BN™ Systems.
Medical device to which equivalence is claimed and comparison information: 6.
The modified N Antisera to Human Transferrin assay is substantially equivalent to the N The modified N Antional terrin currently marketed (K972840). The modified N Antisera to / Introura to Human Transferrin assay, like the current N Antisera to Human Transferrin assay, is intended for the quantitative determination of transferrin by means of immunonephelometry on the BN™ Systems.
Device Performance Characteristics: 7.
To demonstrate equivalence in measurement between serum and heparinized or EDTA plasma, method comparisons were performed. The studies demonstrate equivalent performance with correlation coefficients between 0.96 and 0.98
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three overlapping wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 6 2006
Dade Behring, Inc. c/o Ms. Kathleen A Dray-Lyons Glasgow Site P.O. Box 6101 Newark, DE 19714
Re: K053075
Trade/Device Name: N Antisera to Human Transferrin Regulation Number: 21 CFR 866.5880 Regulation Name: Transferrin immunological test system Regulatory Class: Class II Product Code: DDG Dated: October 28, 2005 Received: November 1, 2005
Dear Ms. Dray-Lyons:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becally be (the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass stared in also introduction of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic nat (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 may of 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); 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and w you'ls ought inding of substantial equivalence of your device to a legally prematics notification: "The PDF Intentig sification 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), please 11 you desire spoonly and (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other Wilsonation of 10.0.2017 responsibilities under the Act from the Division of Small general international on your copying Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert H. Beckerf
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications Statement
Device Name:
N Antisera to Human Transferrin Assay
Indications for Use:
In vitro diagnostic reagents for the quantitative determination of transferrin in human serum, heparinized and EDTA plasma, as well as transferrin in human urine by means of immunonephelometery on the BN™ Systems. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use -(21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Maria Chan
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ion Sign-Off
Alice of In Vitro Diagnostic Device " whichon and Safety
4053075