(45 days)
Not Found
No
The description details a standard turbidimetric immunoassay and does not mention any AI or ML components.
No
The device is described as an in vitro diagnostic device used to measure transferrin levels in human serum and plasma to aid in the diagnosis of various conditions. It does not exert a therapeutic effect on the patient.
Yes
The Intended Use section states that the device is "an in vitro diagnostic device" and that "Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders".
No
The device is a reagent cartridge, which is a physical component used in a clinical chemistry system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The TRNF Flex® reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic device used to measure by immunochemical techniques the transferrin in human serum and heparinized plasma."
N/A
Intended Use / Indications for Use
The TRNF Flex® reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic device used to measure by immunochemical techniques the transferrin in human serum and heparinized plasma. 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
The TRNF Flex® reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay using endpoint detection, based on the precipitation of transferrin (TRNF) by its polyclonal antibody.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Split sample comparison between the TRNF Flex® reagent cartridge method and the Beckman Array® TRF method gave a correlation coefficient of 0.984, slope of 0.90, and an intercept of 7.9 mg/dL when tested with 95 clinical patient samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
0
4 2000 FEB
DADE BEHRI
DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
Summary of Safety and Effectiveness Information
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.
| Submitter's Name: | Richard M. Vaught
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 | |
|--------------------------|----------------------------------------------------------------------------------|--|
| Date of Preparation: | December 20, 1999 | |
| Name of Product: | TRNF Flex® Reagent Cartridge | |
| FDA Classification Name: | Transferrin, Antigen, Antiserum, Control; 82DDG | |
| Predicate Device: | Beckman Array® Transferrin (TRF) method (K780913; K922273) | |
Device Description: The TRNF Flex® reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay using endpoint detection, based on the precipitation of transferrin (TRNF) by its polyclonal antibody.
Intended Use: The TRNF Flex® reagent cartridge is used in the Dimension® clinical chemistry system to quantitatively measure TRNF in human serum and heparinized plasma.
Comparison to Predicate Device:
| Dimension® TRNF Flex® | | Beckman.
TRF method |
|-----------------------|----------------------|------------------------|
| Item | Reagent Cartridge | |
| Sample Type | Serum and plasma | Serum |
| Methodology | Immunoprecipitation | Immunoprecipitation |
| Antibody | Rabbit polyclonal | Goat polyclonal |
| Detection | Bichromatic endpoint | Nephelometry |
| | (340 and 700 nm) | (405 nm) |
| | (turbidimetry) | |
Comments on Substantial Equivalence: Split sample comparison between the TRNF Flex® reagent cartridge method and the Beckman Array® TRF method gave a correlation coefficient of 0.984, slope of 0.90, and an intercept of 7.9 mg/dL when tested with 95 clinical patient samples.
Conclusion: The TRNF Flex® reagent cartridge method is substantially equivalent in principle and performance to the Beckman Array® TRF method based on the split sample comparison discussed above.
R m Vaught
Richard M. Vaught
Regulatory Affairs and Compliance Manager Date: December 20, 1999
1
Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold font. The text is centered in the image. The text is likely the name of a government agency.
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract human figures, represented by flowing lines, stacked on top of each other.
FEB 4 2000 Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101
Re: K994294 Trade Name: Dimension® TRNF Flex® Reagent Cartridge Regulatory Class: II Product Code: DDG Dated: December 20, 1999 Received: December 21, 1999
Dear Mr. Vaught:
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 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). 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 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 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.
2
Page 2
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/dsma/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
3
Indications For Use Statement
Device Name:
Dimension® TRNF Flex® Reagent Cartridge
Indications for Use:
The TRNF Flex® reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic device used to measure by immunochemical techniques the transferrin in human serum and heparinized plasma. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
R M. Van
Richard M. Vaught Regulatory Affairs and Compliance Manager
December 20, 1999
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Maxim
#############################################################################################################################################################################
(Division Sign-Off) Division of Clinical Labora
ﺎ Prescription Use (Per 21 CFR 801.109)
OR
Over-the-counter Use
(Optional format 1-2-96)