(103 days)
Not Found
No
The description details a standard immunoassay method based on light scattering and comparison to known standards. There is no mention of AI/ML algorithms for data analysis, interpretation, or decision support.
No
This device is an in vitro diagnostic (IVD) test used to measure soluble transferrin receptor in human samples to aid in the diagnosis of certain conditions (e.g., iron deficiency anemia). It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the STFR method is an "in vitro diagnostic test" for the quantitative determination of soluble transferrin receptor, and that "Measurements of soluble transferrin receptor aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia."
No
The device description clearly details physical components like reagent cartridges, polystyrene particles, and liquid serum-based calibrators and controls, indicating it is a hardware-based in vitro diagnostic system, not software-only.
Yes, all three devices described are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use / Indications for Use: The descriptions explicitly state that these are "in vitro diagnostic" products and describe their use in testing human samples (serum and plasma) to aid in the diagnosis of various conditions.
- Device Description: The descriptions detail how the devices interact with biological samples (e.g., mixing with samples, scattering light) to produce a result related to a specific analyte (soluble transferrin receptor).
- Performance Studies: The inclusion of a "Method Comparison Study" further supports their classification as IVDs, as performance studies are a standard requirement for demonstrating the analytical performance of diagnostic tests.
- Predicate Devices: The listing of predicate devices (other IVD products) indicates that these devices are being compared to existing diagnostic tests.
Therefore, based on the provided information, all three devices clearly fall under the definition of In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Dimension Vista™ STFR Flex® reagent cartridge: The STFR method is an in vitro diagnostic test for the quantitative determination of soluble transferrin receptor in human serum and heparinized plasma on the Dimension Vista System. Measurements of soluble transferrin receptor 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 Soluble Transferrin Receptor (STFR), 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 soluble transferrin receptor (STFR) on the Dimension Vista System.
Product codes (comma separated list FDA assigned to the subject device)
DDG, JIX, JJY
Device Description
Dimension Vista™ STFR Flex® reagent cartridge: Polystyrene particles coated with monoclonal antibodies specific to human soluble transferrin receptor are aggregated when mixed with samples containing soluble transferrin receptor. These aggregates 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, liguid, human serum based product containing C3 Complement, C4 Complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) and Soluble Transferrin Receptor (STFR).
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, immunoqlobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) and soluble transferrin receptor (STFR).
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison Study: The Dimension Vista™ STFR assay was compared to the Dade Behring N Latex sTR assay on the BN ProSpec® System by evaluating serum and plasma samples with concentrations ranging from 0.21 mg/L to 4.13 mg/L. Regression analysis of these results yielded the following equation: Slope = 1.053, Intercept mg/L = -0.078, Correlation Coefficient = 0.997, n = 153.
Key results: These studies demonstrate correlation and equivalent performance between the Dade Behring N Latex sTfR assay and the Dimension Vista™ STFR assay.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Slope = 1.053, Intercept mg/L = -0.078, Correlation Coefficient = 0.997
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
510(k) Summary for Dimension Vista" STFR 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: K063663
-
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
| Manufacturer: | Dade Behring Marburg GmbH Emil-von-Behring Str. 76 35041 Marburg, Germany |
|---|---|
| --------------- | ----------------------------------------------------------------------------- |
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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
December 7, 2006 Preparation date: -
Dimension Vista" STFR Flex® reagent cartridge
Dimension Vista" Protein 1 Calibrator
Dimension Vista" Protein 1 Calibrator
Dimension Vista", Protein 1 Control M M
Dimension Vi 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 Devices:
Dade Behring N Latex sTFR- K053072 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468
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4. Device Descriptions:
Dimension Vista" STFR Flex reagent cartridge
Polystyrene particles coated with monoclonal antibodies specific to human soluble transferrin receptor are aggregated when mixed with samples containing soluble transferrin receptor. These aggregates 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, liguid, human serum based product containing C3 Complement, C4 Complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) and Soluble Transferrin Receptor (STFR).
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, immunoqlobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) and soluble transferrin receptor (STFR).
5. Device Intended Uses:
Dimension Vista™ STFR Flex® reagent cartridge:
The STFR method is an in vitro diagnostic test for the quantitative determination of soluble transferrin receptor in human serum and heparinized plasma on the Dimension Vista System. Measurements of soluble transferrin receptor 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 Soluble Transferrin Receptor (STFR), 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 soluble transferrin receptor (STFR) on the Dimension Vista System.
6. Medical device to which equivalence is claimed and comparison information:
The Dimension Vista™ STFR assay, like Dade Behring N Latex sTfR is an in vitro diagnostic test for the quantitative measurement of soluble transferrin receptor in human serum and plasma.
Device Performance Characteristics: 7.
The Dimension Vista" STFR assay was compared to the Dade Behring N Latex sTR assay on the BN ProSpec® System by evaluating serum and plasma samples with
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concentrations ranging from 0.21 mg/L to 4.13 mg/L. Regression analysis of these results yielded the following equation.
| Comparative Method | n | Slope | Intercept
mg/L | Correlation
Coefficient |
|-------------------------------------------|-----|-------|-------------------|----------------------------|
| N Latex sTFR on the BN
ProSpec® System | 153 | 1.053 | -0.078 | 0.997 |
Method Comparison Study
8. Conclusion:
These studies demonstrate correlation and equivalent performance between the Dade
Behring N Latex sTfR assay and the Dimension Vista" STFR assay.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 1 2007
Ms. Kathleen A. Dray-Lyons Regulatory Affairs & Compliance Manager Dade Behring Inc. PO Box 6101, M/S 514 Newark DE 19714- 6101
Re: K063663
Trade/Device Name: Dimension Vista™ STFR® Reagent Cartridge Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L Dimension Vista™ Protein 1 Control M Dimension VistaTM Protein 1 Control H Regulation Number: 21 CFR§866.5880 Regulation Name: Transferrin Immunological Test System Regulatory Class: Class II Product Code: DDJ, JIX, JJY Dated: February 12, 2007 Received: February 15, 2007
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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) 276-0490. 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 at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean m. Cooper, M.S., D.v.M.
Yéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Dade Behring Inc. sion Vista™ STFR 510(k) Notification
Indications Statement
Device Name:
Dimension Vista" STFR Flex® reagent cartridge Dimension Vista" Protein 1 Calibrator Dimension Vista Protein 1 Calibrator
Dimension Vista Dimension Vista Protein 1 Control L
Dimension Vista Protein 1 Control Million Protein 1
Dimension Vista Protein 1 Control H
Indications for Use:
Dimension Vista™ STFR Flex® reagent cartridge:
The STFR method is an in vitro diagnostic test for the quantitative determination of soluble transferrin receptor in human serum and heparinized plasma on the Dimension Vista System. Measurements of soluble transferrin receptor 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), lmmunoglobulin G (IGG), Immunoglobulin M (IGM), Prealbumin (PREALB) and Soluble Transferrin Receptor (STFR) 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 Soluble Transferrin Receptor (STFR) on the Dimension Vista® System.
Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)
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