(77 days)
Not Found
No
The device description focuses on a traditional immunoassay method using light scattering and comparison to a standard, with no mention of AI/ML terms or concepts.
No.
The device is an in vitro diagnostic reagent used to measure transferrin levels, aiding in diagnosis, not providing therapy.
Yes
The "Intended Use" section explicitly states that the device is "used as an aid in the diagnosis of latent and manifest iron deficiency and iron overload, and glomerular defects."
No
The device is an in vitro diagnostic reagent, which is a chemical substance used in laboratory tests, not a software-only medical device. It is used in conjunction with a hardware system (Behring Nephelometer Systems).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the product is an "in vitro diagnostic reagent" and is "intended to be used... in the measurement of transferrin in human serum and urine, used as an aid in the diagnosis of latent and manifest iron deficiency and iron overload, and glomerular defects." This clearly indicates its use for diagnostic purposes outside of the living body.
- Device Description: The description details how the product interacts with human samples (serum and urine) to measure a specific substance (transferrin) using an immunological reaction and light scattering. This is a typical process for in vitro diagnostic tests.
- Performance Studies: The document includes performance studies evaluating the product's accuracy and precision when used with human urine samples, which is standard for demonstrating the reliability of an IVD.
- Predicate Device: The mention of a "Predicate Device" (Beckman Transferrin (TRF) Reagent) with a K number (K926272) further confirms that this product is being compared to an already cleared IVD.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
N Antiserum to Human Transferrin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems for the measurement of transferrin in human serum and urine, used as an aid in the diagnosis of latent and manifest iron deficiency and iron overload, and glomerular defects.
Product codes (comma separated list FDA assigned to the subject device)
DDG
Device Description
The proposed product, N Antiserum to Human Transferrin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of transferrin in human serum and urine.
In the proposed product, proteins contained in the human serum or urine samples, form immune complexes 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 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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Correlation:
Comparative studies to measure transferrin in urine using N Antiserum to Human Transferrin and Beckman Transferrin (TRF) Reagent were conducted. In 53 urine samples, ranging from 2.44 to 300.60 mg/L, the correlation coefficient was 0.99, the v-intercept was 0.53 and the slope was 1.01.
Precision:
The N Antiserum to Human Transferrin Reagent was evaluated for the precision of the assay in urine on the Behring Nephelometer. The data analysis protocol was adapted from NCCLS EP5-T. Intra-assay precision %CV ranged from 2.52 to 5.86, and interassay precision %CV ranged from 1.22 to 7.46.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficient was 0.99.
Intra-assay precision %CV ranged from 2.52 to 5.86.
Interassay precision %CV ranged from 1.22 to 7.46.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
OCT 1 7 1997
510(k) SUMMARY FOR N ANTISERUM TO HUMAN TRANSFERRIN
Manufactures Name, Address, Telephone, and contact person, date of 1 . preparation:
| Manufacturer | Behringwerke GmbH
Emil-von-Behring Strasse 76
35041 Marburg
Germany |
|--------------|------------------------------------------------------------------------------|
| Distributor | Behring Diagnostics Inc.
151 University Avenue
Westwood. MA 02090 |
Contact Person: Ruth Forstadt
Date of Preparation: July 31, 1997
Name/ Classification: 2 . Device
N Antiserum to Human Transferrin
FDA has classified N Antiserum to Human Transferrin into Class II (866.5880).
617-320-3000
3 . ldentification of the legally marketed device:
Beckman Transferrin(TRF) Reagent -K926272
4 . Device Description: Proposed
The proposed product, N Antiserum to Human Transferrin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of transferrin in human serum and urine.
In the proposed product, proteins contained in the human serum or urine samples, form immune complexes 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 relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
000023
Confidential
1
Proposed Device Intended Use: 5 .
N Antiserum to Human Transferrin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems for the measurement of transferrin in human serum and urine, used as an aid in the diagnosis of latent and manifest iron deficiency and iron overload, and glomerular defects.
Medical device to which equivalence is claimed and comparison 6. information.
The N Antiserum to Human Transferrin is substantially equivalent in intended use and results to the Beckman Transferrin (TRF) Reagent, in that both methods measure human transferrin in serum and urine.
Performance 7 . Proposed Device Characteristics:
Correlation:
Comparative studies to measure transferrin in urine using N Antiserum to Human Transferrin and Beckman Transferrin (TRF) Reagent were conducted. In 53 urine samples, ranging from 2.44 to 300.60 mg/L, the correlation coefficient was 0.99, the v-intercept was 0.53 and the slope was 1.01.
Precision:
The N Antiserum to Human Transferrin Reagent was evaluated for the precision of the assay in urine on the Behring Nephelometer. The data analysis protocol was adapted from NCCLS EP5-T. Intra-assay precision %CV ranged from 2.52 to 5.86, and interassay precision %CV ranged from 1.22 to 7.46.
CONFIDENTIAL
2
Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other.
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Ruth Forstadt Regulatory Affairs Associate Behring Diagnostics, Inc. 151 University Avenue Westwood, Massachusetts 02090
OCT ! 7 1997
Re: K972840 Trade Name: N Antiserum to Human Transferrin Requlatory Class: II Product Code: DDG Dated: July 31, 1997 Received: Auqust 1, 1997
Dear Ms. Forstadt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device 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 requirement, 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 comply with 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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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity cateqorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 at (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
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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Behring Diagnostics Inc. N Antiserum to Human Transferrin 510(k) Notification
of _ Page
510(k) Number (if known): K972840
Device Name:
N Antiserum to Human Transferrin
- 1.0 27. 1.9 1.0 1.3 1.3 1.4 1.
Indications For Use:
N Antiserum to Human Transferrin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of transferrin in human serum and urine, used as an aid in the diagnosis of latent and manifest iron deficiency and iron overload, and glomerular defects.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Madni
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
0000000
Confidential