(82 days)
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.
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.
This document describes the Dimension Vista™ TRF Flex® reagent cartridge, Dimension Vista™ Protein 1 Calibrator, and Dimension Vista™ Protein 1 Control L, M, and H, which are in vitro diagnostic medical devices. The core of your request focuses on the Dimension Vista™ TRF Flex® reagent cartridge for the quantitative determination of transferrin.
Here's an analysis of the provided information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of pre-defined thresholds. Instead, it presents a method comparison study comparing the new device (Dimension Vista™ TRF assay) with a legally marketed predicate device (Dade Behring N Antisera to Human Transferrin assay on the BN ProSpec® System). The reported device performance from this study serves as the evidence of equivalence to the predicate.
| Performance Metric | Acceptance Criteria (Implied by equivalence) | Reported Device Performance (Dimension Vista™ TRF vs. N Antisera to Human Transferrin on BN ProSpec®) |
|---|---|---|
| Correlation Coefficient | High correlation (e.g., >0.95 or >0.975) | 0.992 |
| Slope | Close to 1 (e.g., 0.95 - 1.05) | 1.087 |
| Intercept | Close to 0 | 0.060 |
Note: The document states, "These studies demonstrate correlation and equivalent performance between the Dade Behring N Antisera to Human Transferrin assay and the Dimension Vista™ TRF assay." This implies that the observed correlation, slope, and intercept values were considered acceptable by the manufacturer for demonstrating substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 180 samples (n = 180)
- Data Provenance: The document does not explicitly state the country of origin. It also does not explicitly state if the data was retrospective or prospective. However, given that it's a method comparison study for an in vitro diagnostic device, it is typically conducted on clinical samples, which are generally considered prospective or retrospective clinical samples collected for research purposes. No specific information on the demographics or collection methods is provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of in vitro diagnostic device (immunoassay for transferrin) does not typically involve human experts for establishing "ground truth" in the same way an imaging or pathology device would. The "ground truth" for method comparison studies like this is the measurement obtained from the predicate device (Dade Behring N Antisera to Human Transferrin assay on the BN ProSpec® System), which is itself an established laboratory method. Therefore, no human experts were involved in establishing the ground truth for this test set; rather, it relied on the analytical performance of a reference method.
4. Adjudication Method for the Test Set
Not applicable. As explained above, the "ground truth" for this method comparison study is the measurement obtained from the predicate device, not an interpretation requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is an in vitro diagnostic assay, not an imaging or interpretive device that would involve multiple human readers. Therefore, an MRMC comparative effectiveness study is not relevant here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in a sense. The study directly compares the analytical performance of the new automated Dimension Vista™ TRF assay (device only) against the predicate automated assay (device only). This is an evaluation of the algorithm/device's performance in generating quantitative results without human interpretive input affecting the result itself. The device is designed to provide a quantitative measurement.
7. Type of Ground Truth Used
The "ground truth" for the performance comparison was the measurements obtained from the legally marketed predicate device, the Dade Behring N Antisera to Human Transferrin assay on the BN ProSpec® System. This is a common approach for demonstrating substantial equivalence for new in vitro diagnostic assays.
8. Sample Size for the Training Set
The document does not provide information about a separate "training set." For in vitro diagnostic assays, especially those based on established immunochemical principles, the development often relies on well-understood chemical reactions and calibration procedures rather than a large, continuously-trained machine learning model in the typical sense. Data used for initial assay development and optimization would precede this validation study, but specifics are not mentioned.
9. How the Ground Truth for the Training Set Was Established
As with point 8, the document does not detail a "training set" or its ground truth establishment. Development of such assays generally involves using characterized reference materials and calibrators, often with values traceable to international standards or established reference methods, to ensure accuracy during the assay's development and optimization phases.
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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
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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 | CorrelationCoefficient |
|---|---|---|---|---|
| N Antisera to Human Transferrinon 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
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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
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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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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Office of In Vitro Diagnostic Device Evaluation and Safety
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§ 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).