(69 days)
Not Found
No
The description details a standard immunochemical assay and calibration/control materials. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic test used for the quantitative determination of Ceruloplasmin, aiding in the diagnosis of copper metabolism disorders. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the CER method "is an in vitro diagnostic test for the quantitative determination of Ceruloplasmin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders." The calibrator and controls are also described as "in vitro diagnostic product".
No
The device description clearly indicates that the device includes physical components such as reagent cartridges, calibrators, and controls, which are liquid, human serum-based products. These are not software-only components. The device also operates on a "Dimension Vista System," which is a hardware platform.
Yes, all three devices described are IVDs (In Vitro Diagnostics).
Here's why:
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Dimension Vista™ CER Flex® reagent cartridge: The "Intended Use / Indications for Use" explicitly states it is an "in vitro diagnostic test". It is used to quantitatively determine Ceruloplasmin in human samples (serum, plasma) to aid in the diagnosis of copper metabolism disorders. This fits the definition of an IVD, which is a medical device used to examine specimens derived from the human body to provide information for diagnostic purposes.
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Dimension Vista™ Protein 1 Calibrator: The "Intended Use / Indications for Use" explicitly states it is an "in vitro diagnostic product". Calibrators are essential components of many IVD systems, used to establish the relationship between the signal measured by the instrument and the concentration of the analyte in the sample.
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Dimension Vista™ Protein 1 Control L, M and H: The "Intended Use / Indications for Use" states they are "assayed intralaboratory quality controls". Quality controls are also crucial for IVD systems to monitor the performance and accuracy of the test. While not directly used to diagnose a patient, they are integral to ensuring the reliability of the diagnostic results.
The descriptions of the devices further support their IVD nature by detailing their composition (human serum based products) and how they are used in the context of laboratory testing for specific proteins.
N/A
Intended Use / Indications for Use
Dimension Vista™ CER Flex® reagent cartridge:
The CER method is an in vitro diagnostic test for the quantitative determination of Ceruloplasmin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.
Dimension Vista™ Protein 1 Calibrator
PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin (PREALB) 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), ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vista® System.
Product codes (comma separated list FDA assigned to the subject device)
DDB; JIX; JJY, CHN, JIX, JJY
Device Description
Dimension Vista™ CER 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, ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
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, ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
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)
Method Comparison Study
The Dimension Vista" CER assay was compared to the Dade Behring N Antisera to Human Ceruloplasmin assay on the BN ProSpec System by evaluating serum and plasma samples with concentrations ranging from 0.09 g/L to 2.20 g/L. Regression analysis of these results yielded the following equation.
Comparative Method: N Antisera to Human Ceruloplasmin on BN ProSpec®
n: 130
Slope: 1.009
Intercept g/L: 0.008
Correlation Coefficient: 0.994
Conclusion: These studies demonstrate correlation and equivalent performance between the Dade Behring N Antisera to Human Ceruloplasmin assay and the Dimension Vista" CER assay
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient: 0.994
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
§ 866.5210 Ceruloplasmin immunological test system.
(a)
Identification. A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
0
Dade Behring Inc. Dimension Vista™ CER 510(k) Notification
FEB 1 5 2007
510(k) Summary for Dimension Vista" CER Flex reagent cartridge Dimension Vista™ Protein 1 Calibrator 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: 1003655
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
| Manufacturer: | Dade Behring Marburg GmbH |
|---|---|
| Emil-von-Behring Str. 76 | |
| 35041 Marburg, Germany |
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 7, 2006
- Dimension Vista" CER Flex® reagent cartridge
Dimension Vista™ Protein 1 Calibrator 2. Device Name: Dimension Vista" Protein 1 Control L Dimension Vista" Protein 1 Control M
Dimension Vista" Protein 1 Control M
Classification: Class II; Class II; Class I Product Code: DDB; JIX; JJY Panel: Immunology (82) and Clinical Chemistry (75)
3. Identification of the Legally Marketed Devices:
Dade Behring N Antisera to Human Ceruloplasmin~ K053074 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468
1
Dade Behring Inc. Dimension Vista™ CER 510(k) Notification
4. Device Descriptions:
Dimension Vista™ CER 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, ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
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, ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
5. Device Intended Uses:
Dimension Vista™ CER Flex® reagent cartridge:
The CER method is an in vitro diagnostic test for the quantitative determination of ceruloplasmin in human serum, heparinized plasma on the Dimension Vista System. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.
Dimension Vista™ Protein 1 Calibrator:
PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin (PREALB) 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), ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vista "System.
6. Medical device to which equivalence is claimed and comparison information:
The Dimension Vista" CER assay, like Dade Behring N Antisera to Human Ceruloplasmin is an in vitro diagnostic test for the quantitative measurement of Ceruloplasmin in human serum and plasma.
7. Device Performance Characteristics:
The Dimension Vista" CER assay was compared to the Dade Behring N Antisera to Human Ceruloplasmin assay on the BN ProSpec System by evaluating serum and plasma samples with concentrations ranging from 0.09 g/L to 2.20 g/L. Regression analysis of these results yielded the following equation.
2
| Comparative Method | n | Slope | Intercept
g/L | Correlation
Coefficient |
|-----------------------------------------------------|-----|-------|------------------|----------------------------|
| N Antisera to Human
Ceruloplasmin on BN ProSpec® | 130 | 1.009 | 0.008 | 0.994 |
Method Comparison Study
8. Conclusion:
These studies demonstrate correlation and equivalent performance between the Dade
Behring N Antisera to Human Ceruloplasmin assay and the Dimension Vista" CER 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular fashion around the eagle. The text is in all capital letters and is relatively small compared to the eagle symbol. The logo is black and white.
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
FEB 1 5 2007
Re: K063655
Trade/Device Name: Dimension Vista™ Ceruloplasmin 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 866.5210 Regulation Name: Ceruloplasmin Immunological Test System Regulatory Class: Class II Product Code: CHN, JIX, JJY Dated: December 7, 2006 Received: December 8, 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 sset forth in the quality systems (QS) 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" (21 CFR 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 Z. Beebech
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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Dimension Vista™ CEF
Indications Statement
Device Name:
Dimension Vista™ CER Flex® reagent cartridge " Protein 1 Calibrator Dimension Vista" Protein 1 Calibrator Dimension Vista™ Protein 1 Control M Dimension Vista™ Protein 1 Control H
Indications for Use:
Dimension Vista™ CER Flex® reagent cartridge:
The CER method is an in vitro diagnostic test for the quantitative determination of Ceruloplasmin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.
Dimension Vista™ Protein 1 Calibrator
PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin (PREALB) 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), ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vista® System.
Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safety KOB3655