(82 days)
No
The device description and performance studies focus on standard immunochemical methods and comparison to predicate devices using traditional statistical metrics. There is no mention of AI/ML algorithms, training data, or related concepts.
No.
The device is an in vitro diagnostic test for the quantitative determination of transferrin, aiding in the diagnosis of various conditions, not for treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the TRF method is an "in vitro diagnostic test" for measuring transferrin, and that "Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia." This clearly indicates its diagnostic purpose.
No
The device description clearly indicates that the device is a reagent cartridge, calibrator, and control, which are physical, liquid-based products used in an in vitro diagnostic test. These are not software-only components.
Yes, all three devices described are explicitly stated to be In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use / Indications for Use: Each section clearly states that the product is an "in vitro diagnostic test" or "in vitro diagnostic product."
- Device Description: The descriptions detail how the devices are used to analyze human samples (serum, plasma) outside of the body to determine the presence and quantity of specific substances (proteins). This is the core definition of an in vitro diagnostic.
- Performance Studies: The performance study describes a "Method Comparison Study" comparing the device to a predicate device, which is a standard practice for demonstrating the performance of IVD devices.
Therefore, based on the provided text, these devices are indeed IVDs.
N/A
Intended Use / Indications for Use
Dimension Vista™ TRF Flex® reagent cartridge:
The TRF method is an in vitro diagnostic test for the quantitative determination of transferrin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia.
Dimension Vista " Protein 1 Calibrator
PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), Prealbumin (PREALB) and Transferrin (TRF) methods on the Dimension Vista" System.
Dimension Vista™ Protein 1 Control L, M and H
PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and transferrin (TRF) on the Dimension Vista® System.
Product codes
DDG, JIX, JJY
Device Description
Dimension Vista™ TRF Flex® reagent cartridge
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 respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista" Protein 1 Calibrator
Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and Transferrin.
Dimension Vista™ Protein 1 Control L, M and H
Protein 1 Control L, M and H are multi-analyte, liquid, human serum based products containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and transferrin.
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
Method Comparison Study comparing Dimension Vista™ TRF assay to Dade Behring N Antisera to Human Transferrin assay on the BN ProSpec® System.
Sample size: 180
Slope: 1.087
Intercept: 0.060
Correlation Coefficient: 0.992
Key Metrics
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).
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JAN 2 4 2007
510(k) Summary for Dimension Vista" TRF Flex® reagent cartridge
Dimension Vista™ Protein 1 Control L. M and H
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.
The assigned 510(k) number is: 10(13322
-
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
Manufacturer: Dade Behring Marburg GmbH Emil-von-Behring Str. 76 35041 Marburg, Germany
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
Contact Information: Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497
Preparation date: December 20, 2006
- Dimension Vista" TRF Flex® reagent cartridge
Dimension Vista" Protein 1 Calibrator
Dimension Vista" Protein 1 Calibrator
Dimension Vista", Protein 1 Control M
Dimension Vista 2. Device Name:
Classification: Class II; Class II; Class I Product Code: DDG; JIX; JJY Panel: Immunology (82) and Clinical Chemistry (75)
3. ldentification of the Legally Marketed Device:
Dade Behring N Antisera to Human Transferrin- K053075 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468
Image /page/0/Picture/12 description: The image contains the word "CONFIDENTIAL" in all capital letters. The text is written in a simple, sans-serif font. The letters are evenly spaced and the word is centered in the image.
Corner 1
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Device Description: 4.
Dimension Vista™ TRF Flex® reagent cartridge
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 respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista" Protein 1 Calibrator
Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and Transferrin.
Dimension Vista™ Protein 1 Control L, M and H
Protein 1 Control L, M and H are multi-analyte, liquid, human serum based products containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and transferrin.
5. Device Intended Use:
Dimension Vista™ TRF Flex® reagent cartridge:
The TRF method is an in vitro diagnostic test for the quantitative determination of transferrin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia.
Dimension Vista™ Protein 1 Calibrator:
PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 complement (C3), C4 complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), Prealbumin (PREALB) and Transferrin (TRF) methods on the Dimension Vista® System.
Dimension Vista" Protein 1 Control L, M and H:
PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and transferrin (TRF) on the Dimension Vista "System.
Medical device to which equivalence is claimed and comparison information: 6.
The Dimension Vista " TRF assay, like the Dade Behring N Antisera to Human Transferrin assay is an in vitro diagnostic test for the quantitative measurement of transferrin in human serum and plasma.
CONFIDENTIAL
2
Device Performance Characteristics: 7.
The Dimension Vista" TRF assay was compared to the Dade Behring N Antisera to Human
Transferrin assay on the BN ProSpec" System and plasma samples vielded the Transferrin assay on the BN ProSpec "System by evaluating of these results yielded the following equation:
Method Comparison Study
| Comparative Method | n | Slope | Intercept | Correlation
Coefficient |
|-------------------------------------------------------|-----|-------|-----------|----------------------------|
| N Antisera to Human Transferrin
on the BN ProSpec® | 180 | 1.087 | 0.060 | 0.992 |
Conclusion: 8.
These studies demonstrate correlation and equivalent performance between the Dade These studies demonstrate conelation and equivalent portomanse on the provincies of the assay.
Behring N Antisera to Human Transferrin assay and the Dimension Vista "TRF assa
CONFIDENTIAL
00012
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dade Behring Inc. c/o Ms. Kathleen Dray-Lyons Regulatory Affairs and Compliance Manager Glasgow Site P.O. Box 6101 Newark, DE 19714-6101
JAN 2 4 2007
Re: K063322
Trade/Device Name: Dimension Vista™ TRF Flex reagent cartridge Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L Dimension Vista™ Protein 1 Control M Dimension Vista™ Protein 1 Control H Regulation Number: 21 CFR 866.5880 Regulation Name: Transferrin Immunological Test System Regulatory Class: Class II Product Code: DDG, JIX, JJY Dated: December 20, 2006
Received: December 26, 2006
Dear Ms. Dray-Lyons:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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 found in 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
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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 (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert A. Bocteel
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
5
Indications Statement
510(k) number: K063322
Dimension Vista™ TRF Flex® reagent cartridge Device Name: Dimension Vista - TRF Flex® reagent of
Dimension Vista - Protein 1 Calibration 1 Calibrary
Dimension Vista - Protein 1 Colibrol L
Dimension Vista - Protein 1 Control L
Dimens " Protein 1 Calibrator Dimension Vista™ Protein 1 Control L
Dimension Vista™ Protein 1 Control M
Dimension Vista™ Protein 1 Control H
Indications for Use:
Dimension Vista™ TRF Flex® reagent cartridge:
The TRF method is an in vitro diagnostic test for the quantitative determination of transferrin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia.
Dimension Vista " Protein 1 Calibrator
PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), Prealbumin (PREALB) and
Transferrin (TRF) methods on the Dimension Vista" System.
Dimension Vista™ Protein 1 Control L, M and H
PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and transferrin (TRF) on the Dimension Vista® System.
Prescription Use × (Per 21 CFR 801 Subpart D)
Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801)
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